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Effect of Nepafenac Eye Drops on Intraocular Pressure in Normal Eyes

Phase 4
Completed
Conditions
Intraocular Pressure
Interventions
Registration Number
NCT01995890
Lead Sponsor
Dr T V Patel Eye Institute
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
327
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
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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)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
nepafenacnepafenacNepafenac 0.1% eye drops, 3 times a day
Primary Outcome Measures
NameTimeMethod
Intraocular pressure8 weeks

Intraocular pressure elevation of more than 4 mmHg from baseline

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Dr TV Patel Eye Insititute

🇮🇳

Vadodara, Gujarat, India

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