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Effect of Nepafenac Eye Drops on Intraocular Pressure in Normal Eyes

Sponsor
Dr T V Patel Eye Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01995890
Collaborator
(none)
327
Enrollment
1
Location
2
Arms
4
Duration (Months)
82.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
327 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Official Title:
Effect of Nepafenac Eye Drops on Intraocular Pressure - a Randomized Prospective Study
Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Feb 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Intraocular pressure [4 weeks]

      Intraocular pressure elevation of more than 4 mmHg from baseline

    2. Intraocular pressure [8 weeks]

      Intraocular pressure elevation of more than 4 mmHg from baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dr TV Patel Eye Insititute Vadodara Gujarat India 390001

    Sponsors and Collaborators

    • Dr T V Patel Eye Institute

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr T V Patel Eye Institute
    ClinicalTrials.gov Identifier:
    NCT01995890
    Other Study ID Numbers:
    • TVPEI
    First Posted:
    Nov 27, 2013
    Last Update Posted:
    Nov 27, 2013
    Last Verified:
    Nov 1, 2013
    Keywords provided by Dr T V Patel Eye Institute
    nepafenac eye drops
    intraocular pressure
    Additional relevant MeSH terms:
    Nepafenac

    Study Results

    No Results Posted as of Nov 27, 2013