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Effect of Nepafenac Eye Drops on Intraocular Pressure in Normal Eyes

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01995890
Enrollment
327
Registered
2013-11-27
Start date
2012-12-31
Completion date
2013-04-30
Last updated
2013-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraocular Pressure

Keywords

nepafenac eye drops, intraocular pressure

Brief summary

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.

Interventions

Sponsors

Dr T V Patel Eye Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Intraocular pressure4 weeksIntraocular pressure elevation of more than 4 mmHg from baseline

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026