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Effect of Nepafenac Eye Drops on Intraocular Pressure in Normal Eyes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01995890
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : November 27, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Intraocular Pressure Drug: nepafenac Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : December 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Nepafenac

Arm Intervention/treatment
Experimental: nepafenac
Nepafenac 0.1% eye drops, 3 times a day
Drug: nepafenac
Other Name: Nevanac

No Intervention: control
No intervention in the control arm



Primary Outcome Measures :
  1. Intraocular pressure [ Time Frame: 4 weeks ]
    Intraocular pressure elevation of more than 4 mmHg from baseline

  2. Intraocular pressure [ Time Frame: 8 weeks ]
    Intraocular pressure elevation of more than 4 mmHg from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995890


Locations
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India
Dr TV Patel Eye Insititute
Vadodara, Gujarat, India, 390001
Sponsors and Collaborators
Dr T V Patel Eye Institute
Investigators
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Principal Investigator: Paaraj R Dave, MD TV Patel Eye Institute
Publications of Results:
Other Publications:
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Responsible Party: Dr T V Patel Eye Institute
ClinicalTrials.gov Identifier: NCT01995890    
Other Study ID Numbers: TVPEI
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: November 2013
Keywords provided by Dr T V Patel Eye Institute:
nepafenac eye drops
intraocular pressure
Additional relevant MeSH terms:
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Nepafenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents