Effect of Nepafenac Eye Drops on Intraocular Pressure in Normal Eyes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intraocular Pressure

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dr TV Patel Eye Insititute

Vadodara, Gujarat, 390001, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nepafenac

Drug

Other names: Nevanac

Primary outcomes

Intraocular pressure

Time frame: 4 weeks

Intraocular pressure elevation of more than 4 mmHg from baseline
Intraocular pressure

Time frame: 8 weeks

Intraocular pressure elevation of more than 4 mmHg from baseline

Sponsors and collaborators

Lead sponsor

Dr T V Patel Eye Institute

Other

Registry information

Official study title

Effect of Nepafenac Eye Drops on Intraocular Pressure - a Randomized Prospective Study

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Nov 27, 2013
Registry last updated: Nov 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed