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Clinical Trials/NCT01995890
NCT01995890CompletedPhase 4

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

Dr T V Patel Eye Institute1 site in 1 country327 target enrollmentStarted: December 2012Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
327
Locations
1
Primary Endpoint
Intraocular pressure
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts 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)

Arms & Interventions

nepafenac

Experimental

Nepafenac 0.1% eye drops, 3 times a day

Intervention: nepafenac (Drug)

Outcomes

Primary Outcomes

Intraocular pressure

Time Frame: 8 weeks

Intraocular pressure elevation of more than 4 mmHg from baseline

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dr T V Patel Eye Institute
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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