Effect of Nepafenac Eye Drops on Intraocular Pressure in Normal Eyes

Intraocular Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01995890
• Other study ID #: TVPEI
• Status: Completed
• Phase: Phase 4
• First received: November 22, 2013
• Last updated: November 22, 2013
• Start date: December 2012
• Est. completion date: April 2013

Study information

• Verified date: November 2013
• Source: Dr T V Patel Eye Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: April 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Intraocular Pressure

Intervention

Drug:
• nepafenac

Locations

Country	Name	City	State
India	Dr TV Patel Eye Insititute	Vadodara	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Dr T V Patel Eye Institute

Country where clinical trial is conducted

India, 

References & Publications (3)

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) — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure	Intraocular pressure elevation of more than 4 mmHg from baseline	4 weeks	Yes
Primary	Intraocular pressure	Intraocular pressure elevation of more than 4 mmHg from baseline	8 weeks	Yes