Full text of DOI:10.1007/s004170100346

Graefe’s Arch Clin Exp Ophthalmol
(2001) 239:737–742
C L I N I C A L I N V E S T I G AT I O N
DOI 10.1007/s004170100346
Hans Gert Struck
Annett Bariszlovich
Comparison of 0.1% dexamethasone
phosphate eye gel (Dexagel)
and 1% prednisolone acetate eye suspension
in the treatment of post-operative
inflammation after cataract surgery
Abstract A prospective, multi-cen-
tre, clinical parallel group study was concerning primary and secondary
conducted to assess the efficacy and efficacy criteria. The mean reduction
safety of a new 0.1% dexamethasone in anterior chamber flare from day
phosphate eye gel (Group 1, n=117) 1 to day 14 post-operatively was
ences between the treatment groups
Received: 26 March 2001
Revised: 27 June 2001
Accepted: 27 June 2001
Published online: 19 September 2001
© Springer-Verlag 2001
compared to 1%prednisolone acetate 8.34±20.80 photons/ms with 0.1%
eye suspension (Group 2I, n=119) in dexamethasone eye gel and
a total of 236 patients (safety popu-
lation), aged 39–92 years, following
cataract surgery. Both drugs were
given four times a day for 14 days
5.72±16.70 photons/ ms with 1%
prednisolone eye suspension. The
mean reduction of inflammation se-
verity score was 1.8±1.3 points in
starting 24±4 h after surgery. Criteria Group 1 and 2.0±1.1 points in Group
for evaluation were the reduction in
anterior chamber flare and inflam-
mation severity score (primary effi-
2. Intra-ocular pressure did not in-
crease after treatment with 0.1%
dexamethasone phosphate eye gel.
cacy criteria) as well as different sec- Conclusion: the results of the study
ondary efficacy and safety evalua-
tion criteria. Laser photometry
(LFM-500, Kowa), slit lamp assess-
ment and the examination of other
objective and subjective symptoms
underline the protective effect of
topically applied 0.1% dexametha-
sone phosphate eye gel on the blood-
aqueous barrier. This drug is an
effective and safe steroidal anti-
H.G. Struck ( ) · A. Bariszlovich
✉
Department of Ophthalmology,
Martin-Luther-University Halle-Wittenberg,
Magdeburger Strasse 8,
06097 Halle/Saale, Germany
e-mail:
hans-gert.struck@medizin.uni-halle.de
Tel.: +49-345-5571551
Fax: +49-345-5574647
of ocular discomfort were performed inflammatory agent for topical use
between the last preoperative and
14th post-operative day. There were
no statistically significant differ-
following cataract surgery and intra-
ocular lens implantation.
formation of posterior subcapsular cataract, and delay in
corneal healing.
Introduction
Dexamethasone and prednisolone are halogenated gluco-
Until recently, dexamethasone sodium phosphate was
corticoids with a potent anti-inflammatory effect. Both commercially available in Germany in the form of aque-
agents are topically applied routinely after intra-ocular ous eye drops only. Now, a new formulation has been de-
surgery to reduce conjunctival, perikeratic and iridal hy- veloped in the form of a viscous crystal-clear gel (Dexa-
peraemia, prevent the breakdown of the blood-aqueous gel, Dr. Mann Pharma GmbH, Berlin) containing the wa-
barrier and to inhibit cellular infiltration into target tis- ter soluble ester of dexamethasone, dexamethasone sodi-
sues. The clinical utility of corticosteroid eye drops is um phosphate, at a concentration of 0.1%. The addition
limited by some known side-effects occurring after pro- of a viscoelastic agent (carbomer) increases the viscosity
longed administration. Ocular adverse effects include el- of the formulation. In rabbits, a pharmacokinetic com-
evation of intra-ocular pressure, masking of infection, parison of an aqueous dexamethasone solution versus

738
ing criteria were used for the evaluation of the two preparations
from preoperative Day –1 (visit 1), Day 0 (surgery), Day 1 (visit
2), Day 3 (visit 3), Day 7 (visit 4) to Day 14±2 (visit 5) : (1) pri-
mary efficacy consisting of, reduction in anterior chamber flare,
and reduced inflammation severity score (cells and flare in the an-
terior chamber), (2) secondary efficacyconsisting of reduced cor-
neal oedema, reduction of Descemet folds, reduction of intraocu-
lar debris on lens, change in visual acuity, and global efficacy as-
sessment (frequency of clinical cure);(3) safety evaluation: ad-
verse events, intraocular pressure, local tolerance and vital signs.
The following parameters were measured at each visit using the
methods described: the Tyndall effect in the anterior chamber us-
ing the LFM-500 laser flare photometer (Kowa) based on the
method described by Sawa et al. [20] and Oshika et Araie [17],
clinical-biomicroscopic parameters assessed by slit lamp examina-
tion, visual acuity examined using standard equipment, and intra-
ocular pressure determined by applanation tonometry. The signs
and symptoms were scored using different rules and scales. Ad-
verse events were assessed with respect to their intensity using the
categories mild, moderate and severe.
dexamethasone gel demonstrated that bioavailability of
dexamethasone phosphate in corneal tissue and aqueous
humour is increased after application of Dexagel, proba-
bly as a result of greater initial saturation of the tear film
and a slower rate of elimination [13].
The aim of the present study was to investigate the ef-
fects of this 0.1% dexamethasone phosphate eye gel on
post-operative inflammation following cataract surgery
after a treatment period of 14 days. The reference prepa-
ration was an eye suspension containing 1% predniso-
lone acetate.
Subjects and methods
This prospective, multi-centre, active-controlled, open, clinical
parallel group study describes the results of 236 patients (safety
population) scheduled for phaco emulsification by the tunnel tech-
nique with sclerocorneal incision. The study was reviewed by the
appropriate Ethics Committee. The tenets of the World Medical
Association Declaration of Helsinki were followed and prior in-
formed consent was obtained from all patients.
After screening on the basis of defined inclusion and exclusion
criteria, the total of 236 cataract patients (87 male, 149 female),
aged 39–92 years (average age 70.8 years) were included succes-
sively in the study in seven different centres between January and
October 1999. At each centre, all surgery was performed by one
surgeon with comparable surgical experience and surgical tech-
nique. The number of examiners was not specified. Patients to be
included in the study were at least 40 years of age, suffered from
pre-senile or senile cataract and were planned for cataract surgery.
The eye concerned had to be free of irritations. Exclusion criteria
were a history of hypersensitivity to steroids or other components
of the study medication, diabetes mellitus, herpes simplex virus
infection, uveitis, glaucoma and surgical interventions of the eye
concerned within 2 months preceding surgery. Exclusion criteria
regarding present conditions were infections, inflammation, severe
dry eye syndrome and corneal lesions of the eye concerned.
Statistics
The statistical analysis procedures, as laid down in the protocol,
were described in detail in the analysis plan which was prepared
by “staticon international” (Verum Staticon GmbH, Planegg). The
study was designed to show one-sided non-inferiority (at the 2.5%
significance level) of 0.1% dexamethasone eye gel compared to
1% prednisolone eye suspension. The test preparation 0.1% dexa-
methasone eye gel was to be considered as not being inferior if the
reduction of the main efficacy variable (anterior chamber flare)
with 0.1% dexamethasone eye gel was greater than 80% of that
with 1% prednisolone eye suspension. The confirmatory analysis
was based on the PP population. Additionally, an exploratory anal-
ysis based on the ITT population was performed in order to check
for internal consistency of the results.
The tests were calculated by t-test (ANCOVA). For the second-
ary efficacy criteria, two-sided exploratory tests for differences
between 0.1% dexamethasone eye gel and 1% prednisolone eye
suspension were performed at the 5% significance level (Mantel-
Haenszel chi-squared test and analysis of covariance). An explor-
atory analysis of covariance for the primary efficacy criteria was
carried out with additional treatment-by-centre interaction, both
for the PP population and ITT population. There was no evidence
of centre specific treatment effects either in the PP population or
in the ITT population.
Distribution of patients:
Patients were randomly allocated to one of the following therapeu-
tic groups: Group 1 (n=117, 47 males, 70 females); therapy with
0.1% dexamethasone phosphate eye gel (Dexagel) and Group 2
(n=119, 40 males, 79 females); therapy with 1% prednisolone ace-
tate eye suspension. Some 16 patients of the safety population
(Group 1: 6; Group 2: 10) were withdrawn from the study after
randomisation due to different reasons for premature study termi-
nation. As 13 of the 236 patients of the safety population did not
meet the criteria for the intention-to-treat (ITT) population and 47
patients had at least one major protocol violation, the ITT popula-
tion consisted of 223 patients (Group 1: 112, Group 2: 111) and
the per protocol (PP) population comprised 189 patients (Group 1:
92, Group 2: 97). BothPP and ITT populations were used for the
analysis of clinical efficacy.
Results
Primary efficacy criteria
The mean reduction in anterior chamber flare from Day
1(24±4 h after surgery) to Day 14 was 8.34±20.80 pho-
tons/ms (median 4.00 photons/ms) with 0.1% dexameth-
asone eye gel (Group 1) and 5.72±16.70 photons/ms
(median 3.10 photons/ms) with 1% prednisolone eye
suspension (Group 2) (Fig.1). The mean reduction in in-
flammation severity score in the same post-operative pe-
riod was 1.8±1.3 points (median 2.0 points) in Group 1
and 2.0±1.1 points (median 2.0 points) in Group 2
(Fig.2). Confirmatory testing showed statistically signifi-
cant non-inferiority of 0.1% dexamethasone eye gel
Treatments:
From Day 1 (24±4 h after surgery) until Day 14, the study medica-
tion (marketed preparations) was to be applied four times a day.
At each administration, one drop of study medication was to be in-
stilled into the lower conjunctival fold of the operated eye. Con-
comitant therapy given in both groups was identical. The follow-

739
Fig. 2 Inflammation severity score from preoperative Day –1
(visit 1) to Day 14±2 (visit 5); slit lamp examination of cells and
flare in the anterior chamber; PPpopulation (n=189). Dexametha-
sone 0.1% eye gel (dex) (n=92), prednisolone 1% eye suspension
(predn) (n=97)
Fig. 1 Anterior chamber flare from preoperative Day –1 (visit 1)
to Day 14±2 (visit 5); laser tyndallometry; PPpopulation (n=189).
Dexamethasone 0.1% eye gel (dex), (n=92); prednisolone 1% eye
suspension (predn) (n=97)
compared to 1% prednisolone eye suspension with re-
spect to reduction in anterior chamber flare (P=0.0019,
one-sided) and reduction in inflammation severity score
(P<0.0001, one-sided). Superiority of 0.1% dexametha-
sone eye gel over 1% prednisolone eye suspension could
not be demonstrated (P=0.1927, one-sided, for reduction
in anterior chamber flare and P=0.6347, one-sided, for
reduction in inflammation severity score). These results
were supported by the exploratory analysis of the prima-
ry efficacy criteria, based on the ITT population, which
also showed statistically significant one-sided non-inferi-
ority of 0.1% dexamethasone eye gel compared to 1%
prednisolone eye suspension, but not superiority.
Fig. 3 Change in best corrected visual acuity from Day 1 (visit 2)
to Day 14±2 (visit 5): 0.2±0.2 (both groups) PP population
(n=189). Dexamethasone (dex) (n=92), prednisolone (predn)
(n=97)
Secondary efficacy criteria
There was no statistically significant difference between
the treatment groups from Day 1 to Day 14 with respect
It must be taken into consideration that the relative
to the reduction in corneal oedema (P=0.242, two-sided), frequency of patients with abnormal baseline conditions
Descemet folds (P=0.682, two-sided) and intraocular de- (at Day 1) was higher for two criteria in the prednisolone
bris on lens (P=0.168, two-sided), respectively (Table1). group as compared to the dexamethasone group (reduc-
Exploratory testing did not show statistically significant tion in corneal oedema and Descemet folds, respectively)
differences between the treatment groups with respect to and for the criterion “reduction of intraocular debris on
the change in visual acuity (P=0.404, two-sided (Fig.3) lens” higher in the dexamethasone group as compared to
and the global efficacy assessment (P=0.209, two-sided). the prednisolone patients.
Table 1 Secondary efficacy criteria (selection) from Day 1 (visit 2) to Day 14±2 (visit 5); slit lamp examination, PP population (n=189)
Criterion
Reduced (%)
Unchanged (%)
Increased (%)
Dexamethasone Prednisolone
Dexamethasone
(n=92)
Prednisolone
(n=97)
Dexamethasone Prednisolone
(n=92)
(n=97)
(n=92)
(n=97)
Change in corneal oedema
Change in Descement folds
Change in intraocular
debris on lens
37.0
29.3
18.5
44.3
37.1
11.3
62.0
68.5
81.5
54.6
60.8
88.7
1.1
2.2
0
1.0
2.1
0

740
Fig. 5 Subjective local tolerance from Day 3 (visit 3) to Day 14±2
(visit 5); safety population (n=236). Dexamethasone (dex)
(n=117), predisolone (predn) (n=119). Scale: very good = no irri-
tation; good = slight irritation, ≤5 min; moderate = marked irrita-
tion, >5 min
Fig. 4 Intraocular pressure from preoperative Day –1 (visit 1) to
Day 14±2 (visit 555]. Applanation tonometry. Safety population
(n=236).Dexamethasone (dex) (n=117), predisolone (predn) (n=119)
The secondary efficacy criteria were additionally compared to the prednisolone group. There were no rele-
analysed for the ITT population using the same test pro- vant differences between the treatment groups with re-
cedures as described for the PP population. Exploratory spect to mean values of vital signs. The mean values
testing did not show statistical significant differences be- were within the normal range at each visit.
tween both treatment groups with respect to any of the
secondary efficacy criteria.
Discussion
Safety evaluation
Published reports have shown that the post-operative in-
flammatory response after cataract surgery may be relat-
The analysis of adverse events, “intraocular pressure”, ed to such factors such as previous alteration of the
“local tolerance”, and “vital signs” (systolic and diastolic blood-aqueous-barrier, surgical equipment and tech-
blood pressure and pulse) was carried out on the safety nique, incision size, intraocular lens type, and degree of
population (n=236), which was defined as patients who iris pigmentation [3, 7, 8, 10,16]. The anti-inflammatory
received at least one dose of study medication. The inci- effects of topically applied corticosteroids which are ad-
dence of adverse events assessed as related to the admin- ministered during the perioperative period have been
istration of study medication was equal in the treatment clearly demonstrated in clinical trials [25]. Our reference
groups.
preparation, 1% prednisolone acetate eye drops (aqueous
Overall, in four patients (two patients in each treat- suspension), has been shown to readily penetrate the cor-
ment group), the adverse events were considered to be nea [5], exhibit prolonged bioavailability in the aqueous
related to the administration of study medication (dexa- humour [14] and to have marked anti-inflammatory ef-
methasone group: face oedema, conjunctivitis, corneal fects in the post-cataract surgery period [2, 21,23].
oedema and ulceration; prednisolone group: conjunctivi-
With respect to the primary efficacy criteria “reduc-
tis and decrease of intraocular pressure). The intraocular tion in anterior chamber flare” and “reduction in inflam-
pressure was measured at each visit. There were no rele- mation severity score”, the test medication, 0.1% dexa-
vant differences between the treatment groups with re- methasone phosphate eye gel, was equivalent to the ref-
spect to the mean values of intraocular pressure. The erence preparation. Concerning the secondary efficacy
mean values were within the normal range at each visit. criteria, the two preparations exhibited practically identi-
In both treatment groups, the mean intraocular pressure cal clinical effects. There were no statistically significant
in the operated eye was comparable to that in the not op- differences between 0.1% dexamethasone phosphate eye
erated eye (Fig.4).
gel and 1% prednisolone acetate eye suspension with re-
From Day 3 (visit 3) up to the end of treatment, the spect to the criteria “reduction in corneal oedema”, “re-
subjective local tolerance was examined by questioning duction in Descemet folds”, “reduction of intraocular de-
the patient (Fig.5). At the end of treatment (visit 5), the bris on lens”, “change of visual acuity”, or “global effi-
relative frequency of patients who assessed the local tol- cacy assessment”. Regarding the baseline values of cor-
erance of the study medication as very good was slightly neal oedema and Descemet folds (Day 1, post-opera-
higher among the patients in the dexamethasone group as tive), the number of patients with corneal oedema and

741
Descemet folds was higher in the prednisolone group as achieves in the cornea and in the aqueous humour, re-
compared to the dexamethasone group. This fact could spectively [11]. The contact time of the drug system with
possibly explain the higher percentage of prednisolone the precorneal tear film is largely determined by the vis-
patients with a reduction in corneal oedema and Descem- cosity of the vehicle [22]. In a previous study we com-
et folds respectively as compared to the dexamethasone pared the effect of 0.5% prednisolone acetate eye gel
patients. On the other hand, the reduction of intraocular with 1% prednisolone acetate eye suspension in a clini-
debris on lens was more frequent under dexamethasone cal trial with a total of 63 patients, following cataract
as compared to prednisolone. The baseline values surgery. Both evaluated drugs showed equivalence con-
showed more patients with debris on lens in the dexa- cerning the anti-inflammatory efficacy [24].
methasone group than in the prednisolone group. The in-
crease in visual acuity was equal in both treatment centration-time response curve shows better availability
groups. of 50 µl 0.1% dexamethasone phosphate in the cornea
In an animal experiment with albino rabbits the con-
Corticosteroids vary in their inherent anti-inflamma- and aqueous humour when topically applied as an eye
tory potency. Prednisolone is four times more potent gel in comparison to eye drops [13]. The animal experi-
than hydrocortisone and dexamethasone is 25 times as ment demonstrated that due to the prolonged corneal
potent as hydrocortisone [12]. Dexamethasone has an in- contact time the gel formulation increases the bioavail-
herent systemic anti-inflammatory potency which is 5–7 ability of dexamethasone in the cornea and doubles the
times greater than that of prednisolone. However, it has area under the concentration-time curve in aqueous
been suggested that these systemic differences in poten- humour compared with the same drug applied as an
cy cannot be extrapolated directly to the eye. Lipophilic aqueous solution. Maximum concentration (Cmax) was
acetate and alcohol corticosteroid preparations penetrate moderately, but statistically significantly higher in the
the intact corneal epithelium better than polar prepara- cornea (2.05 µg/g versus 1.13 µg/g) and aqueous humour
tions such as sodium salts of the steroid phosphate. Thus, (0.22 µg/ml versus 0.14 µg/ml) of the group having re-
the mean peak concentration in human aqueous humour ceived the ophthalmic gel. This would explain, together
following the separate topical administration of 50 µl of with the different anti-inflammatory potency and the glu-
1% prednisolone acetate is 669.6±135.5 ng/ml and of cocorticoid-receptor binding capacity, the equivalence of
0.5% prednisolone phosphate only 25.6±4.0 ng/ml clinical effects of 0.1% dexamethasone phosphate eye
[6,14]. McGhee et al. [14] reported a mean concentration gel and 1% prednisolone acetate eye suspension. This ef-
of 0.67 µg/ml in human aqueous humour 1.5–2 h after fect can be utilised to improve the safety of the cortico-
instillation of 50 µl of 1% prednisolone acetate in the steroid during use.
conjunctival sac. After 20 h, the mean level had fallen to
0.03 µg/ml.
In the study presented here, adverse events assessed
as related to the administration of study medication were
Although 0.1% dexamethasone has a better anti- rare and the incidence was equal in the treatment groups.
inflammatory potency and a higher glucocorticoid-recep- There was no indication of any ocular side-effect. Ocular
tor binding capacity, it is hardly able to protect the adverse effects might also include a rise in the intraocu-
blood-aqueous barrier in a significantly better way than lar pressure, especially in steroid-responders, but this ef-
1% prednisolone acetate. One reason for this might be fect should be less pronounced for prednisolone than for
the better corneal penetration of prednisolone acetate [5]. dexamethasone [1, 18, 19]. We did not observe any in-
Midelfart et al. [15] investigated the penetration of dexa- fluence of the study medication on the mean values of
methasone phosphate into the aqueous humour and its intraocular pressure. The mean values were within the
metabolism using NMR spectroscopy. These investiga- normal range at each visit. For no patient in the dexa-
tions have confirmed that dephosphorylation of the pro- methasone group, increase of ocular pressure was report-
drug, dexamethasone phosphate, occurred in the cornea. ed as an adverse event. Concerning the mean values of
On the other hand, the penetration rate of dexamethasone intraocular pressure and local tolerance, 0.1% dexameth-
phosphate increases distinctly in an inflamed eye or asone eye gel and 1% prednisolone eye suspension were
when the epithelium of the cornea is no longer intact [4]. comparable. The clinical findings together with the re-
Furthermore, it has been documented that the formula- sults of the patients’ reports of symptoms of ocular dis-
tion of drugs (particularly vehicle and preservative) can comfort correlated well with the objectively evaluated
significantly influence the penetration of topically ap- data. In conclusion, the results of the study underline the
plied steroids [9]. The variables include the concentra- protective effect of topically applied 0.1% dexametha-
tion of the drug in the vehicle, the volume of the instilled sone phosphate eye gel on the blood-aqueous barrier af-
dose, the viscosity of the vehicle, the influence of tear ter cataract extraction and IOL implantation and the
turnover and drainage on the instilled dose, and the ab- equivalent anti-inflammatory efficacy of 0.1% dexa-
sorption and elimination characteristics of the drug. Con- methasone phosphate eye gel compared to 1% predniso-
tact time of a topically administered drug with the eye lone acetate eye suspension.
plays a major role in the concentration that the drug

742
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