Effect of Nepafenac Eye Drops on Intraocular Pressure in Normal Eyes

Overview

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.

Full Title of Study: “Effect of Nepafenac Eye Drops on Intraocular Pressure – a Randomized Prospective Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2013

Interventions

  • Drug: nepafenac

Arms, Groups and Cohorts

  • Experimental: nepafenac
    • Nepafenac 0.1% eye drops, 3 times a day
  • No Intervention: control
    • No intervention in the control arm

Clinical Trial Outcome Measures

Primary Measures

  • Intraocular pressure
    • Time Frame: 4 weeks
    • Intraocular pressure elevation of more than 4 mmHg from baseline
  • Intraocular pressure
    • Time Frame: 8 weeks
    • Intraocular pressure elevation of more than 4 mmHg from baseline

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Dr T V Patel Eye Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Paaraj R Dave, MD, Principal Investigator, TV Patel Eye Institute

References

Gamache DA, Graff G, Brady MT, Spellman JM, Yanni JM. Nepafenac, a unique nonsteroidal prodrug with potential utility in the treatment of trauma-induced ocular inflammation: I. Assessment of anti-inflammatory efficacy. Inflammation. 2000 Aug;24(4):357-70. doi: 10.1023/a:1007049015148.

Citations Reporting on Results

Chiba T, Kashiwagi K, Chiba N, Tsukahara S. Effect of non-steroidal anti-inflammatory ophthalmic solution on intraocular pressure reduction by latanoprost in patients with primary open angle glaucoma or ocular hypertension. Br J Ophthalmol. 2006 Mar;90(3):314-7. doi: 10.1136/bjo.2005.080895.

Warren KA, Fox JE. Topical nepafenac as an alternate treatment for cystoid macular edema in steroid responsive patients. Retina. 2008 Nov-Dec;28(10):1427-34. doi: 10.1097/IAE.0b013e31817e7ead.

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