Effect of Nepafenac Eye Drops on Intraocular Pressure in Normal Eyes

November 22, 2013 updated by: Dr T V Patel Eye Institute

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

327

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Gujarat
      • Vadodara, Gujarat, India, 390001
        • Dr TV Patel Eye Insititute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nepafenac
Nepafenac 0.1% eye drops, 3 times a day
Drug: nepafenac
Other Names:
  • Nevanac
No Intervention: control
No intervention in the control arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure
Time Frame: 4 weeks
Intraocular pressure elevation of more than 4 mmHg from baseline
4 weeks
Intraocular pressure
Time Frame: 8 weeks
Intraocular pressure elevation of more than 4 mmHg from baseline
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr T V Patel Eye Institute

Investigators

  • Principal Investigator: Paaraj R Dave, MD, TV Patel Eye Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

November 22, 2013

First Submitted That Met QC Criteria

November 22, 2013

First Posted (Estimate)

November 27, 2013

Study Record Updates

Last Update Posted (Estimate)

November 27, 2013

Last Update Submitted That Met QC Criteria

November 22, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TVPEI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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