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Effect of Nepafenac Eye Drops on Intraocular Pressure in Normal Eyes

Information source: Dr T V Patel Eye Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Intraocular Pressure

Intervention: nepafenac (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Dr T V Patel Eye Institute

Official(s) and/or principal investigator(s):
Paaraj R Dave, MD, Principal Investigator, Affiliation: TV Patel Eye Institute

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Primary outcome:

Intraocular pressure

Intraocular pressure

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Dr TV Patel Eye Insititute, Vadodara, Gujarat 390001, India
Additional Information

Related publications:

Gamache DA, Graff G, Brady MT, Spellman JM, Yanni JM. Nepafenac, a unique nonsteroidal prodrug with potential utility in the treatment of trauma-induced ocular inflammation: I. Assessment of anti-inflammatory efficacy. Inflammation. 2000 Aug;24(4):357-70.

Starting date: December 2012
Last updated: November 22, 2013

Page last updated: August 23, 2015

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