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Effect of Nepafenac Eye Drops on Intraocular Pressure in Normal Eyes

NCT ID: NCT01995890

Last Updated: 2013-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

327 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-04-30

Brief Summary

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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

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Conditions

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Intraocular Pressure

Keywords

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nepafenac eye drops intraocular pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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nepafenac

Nepafenac 0.1% eye drops, 3 times a day

Group Type EXPERIMENTAL

nepafenac

Intervention Type DRUG

control

No intervention in the control arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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nepafenac

Intervention Type DRUG

Other Intervention Names

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Nevanac

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr T V Patel Eye Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paaraj R Dave, MD

Role: PRINCIPAL_INVESTIGATOR

TV Patel Eye Institute

Locations

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Dr TV Patel Eye Insititute

Vadodara, Gujarat, India

Site Status

Countries

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India

References

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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.

Reference Type BACKGROUND
PMID: 10850857 (View on PubMed)

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.

Reference Type RESULT
PMID: 16488953 (View on PubMed)

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.

Reference Type RESULT
PMID: 18664937 (View on PubMed)

Other Identifiers

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TVPEI

Identifier Type: -

Identifier Source: org_study_id