Pterygium Clinical Trial
Official title:
Efficacy and Safety of PRO-155 (Zebesten Ofteno®) on Inflammation of the Conjunctival Surface in Subjects With Grade I-III Pterygium vs Placebo.
Title of the study Efficacy and safety of PRO-155 (Zebesten ofteno®) on inflammation of the
conjunctival surface in subjects with grade I-III pterygium vs placebo.
Hypothesis H0. The Zebesten® ophthalmic solution (bromfenac 0.09%) is less effective and safe
than placebo in reducing conjunctival hyperemia in subjects with grade I-III pterygium.
H1 The Zebesten® ophthalmic solution (bromfenac 0.09%) is more effective and safe than
placebo in reducing conjunctival hyperemia in subjects with grade I-III pterygium.
Objective
To evaluate the efficacy and safety of PRO-155 (bromfenac 009%) ophthalmic solution in the
treatment of conjunctival hyperemia and ocular surface inflammation in a clinical model of
pterygium grade I to III.
Variables to be evaluated Visual ability Intraocular pressure. Ocular surface Exploration of
the previous segment. Exploration of the posterior segment. Lacrimal rupture time. Corneal
de-epithelialization Conjunctival de-epithelialization Adverse events.
PHARMACOLOGICAL INTERVENTION
The pharmacological intervention will consist of the instillation of the ophthalmological
solution in the conjunctival cul-de-sac, during the waking period, to any of the following
study groups:
- Group 1:
- Sodium hyaluronate 0.4% [Lagricel ofteno®] 1 drop 3 times a day in the period of
vigil in the conjunctival sac fund (the following application scheme is suggested:
start: 7:00 ± 1 hours, continuation: 15:00 ± 1 hour and term: at 19:00 ± 1 hours)
for 20 days
- Pro-155 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac
(the following application scheme is recommended: start: 7:15 ± 1 hours and term:
at 19:15 ± 1 hours) during 20 days
- Group 2:
- Sodium hyaluronate 0.4% [Lagricel ofteno®] 1 drop 3 times a day in the period of
vigil in the conjunctival sac fund (the following application scheme is suggested:
start: 7:00 ± 1 hours, continuation: 15:00 ± 1 hour and term: at 19:00 ± 1 hours)
for 20 days
- Placebo 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac
(the following application scheme is recommended: start: 7:15 ± 1 hours and term:
at 19:15 ± 1 hours) for 20 days
;
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