Effect of Nepafenac Eye Drops on Intraocular Pressure in Normal Eyes

Dr T V Patel Eye Institute

Status and phase: Completed; Phase 4

Conditions: Intraocular Pressure

Treatments: Drug: nepafenac

Study type: Interventional

Funder types: Other

Identifiers

NCT01995890

TVPEI

Details and patient eligibility

About

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.

Enrollment: 327 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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)

Trial design

327 participants in 2 patient groups

nepafenac

Experimental group

Description:

Nepafenac 0.1% eye drops, 3 times a day

Treatment:

Drug: nepafenac

control

No Intervention group

Description:

No intervention in the control arm