Effect of Nepafenac Eye Drops on Intraocular Pressure in Normal Eyes

Phase 4CompletedNCT01995890

Dr T V Patel Eye Institute327 enrolled

Overview

The Nevanac product information insert says that it can cause increase in eye pressure in 5-10% of patients. There is very little published literature on the effect of topical Nepafenac eye drops on eye pressure in normal people. The purpose of our study is to report this effect with a working hypothesis that there is no increase in eye pressure following use of Nepafenac eye drops.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

327

Conditions

Intraocular Pressure

Interventions

nepafenacDRUG

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Best corrected visual acuity better than 20/80 in both eyes * Intraocular pressure ≤21 mmHg in both eyes * Open angles on 4 mirror gonioscopy without indentation * Normal optic disc on stereoscopic examination and photographs Exclusion Criteria: * Change in the systemic medication profile during the course of the study * Allergy to nepafenac molecule * Corneal thinning/corneal infections * Any intraocular surgery in past 3 months * Pregnancy or those planning to conceive * Breast feeding patients * Unwillingness to participate in the trial * Concomitant use of any other ocular drug (except artificial tears)

Locations (1)

Dr TV Patel Eye Insititute

Vadodara, Gujarat, India

Outcomes

Primary Outcomes

Intraocular pressure

Intraocular pressure elevation of more than 4 mmHg from baseline

Time frame: 4 weeks

Intraocular pressure

Intraocular pressure elevation of more than 4 mmHg from baseline

Time frame: 8 weeks

Data from ClinicalTrials.gov

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