Efficacy and Safety of PRO-155 on Inflammation of the Conjunctival Surface in Subjects With Grade I-III Pterygium vs Placebo.

• Status: Completed
• Trial end date: 2018-10-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Sophia S.A de C.V.
• Treatments: Anti-Inflammatory Agents; Bromfenac; Ophthalmic Solutions

Criteria

Inclusion Criteria:

• Age of 18 to 90 years.

• Both genders.

• Clinical diagnosis of grade I to III pterygium (temporal, nasal, or bitemporal).

• Possibility of going to the revisions when indicated.

Exclusion Criteria:

• Subjects with topical or systemic medication that interfere decisively in the results of the study; such as topical immunomodulators, NSAIDs, antihistamines, corticosteroids, artificial tears with conservative, vasoconstrictors etc.

• Subjects (female) with active sexual life who do not use a contraceptive method.

• Subjects of the female sex in a pregnant state or who are breastfeeding.

• Subjects of the female sex with pregnancy test in positive urine.

• Positive substance abuse

• Subjects who have participated in any clinical research study in the last 40 days.

• Subjects legally or mentally incapacitated to give their informed consent for their participation in this study.

• Subjects that can not comply with the appointments or with all the requirements of the Protocol.