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A clinical trial to study the intraocular pressure lowering effect of an anti-glaucoma drug, LUMIGAN® (bimatoprost ophthalmic solution) 0.03%, in treating subjects who are new to treatment compared to subjects who are on prostaglandin only treatment

Phase 4
Registration Number
CTRI/2011/091/000204
Lead Sponsor
Johnson & Johnson Vision Care, Inc.7500 Centurion Parkway, Suite 100Jacksonville, FL 32256, USA
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Other (Terminated)
Sex
Not specified
Target Recruitment
40
Inclusion Criteria

A.Male or female 21 years of age or greater.
B.Diagnosis of mild open angle glaucoma.
C.IOP must meet the following criteria for "study eye" in both eyes: between 22 and 34 mmHg inclusive at the set time measurement at Visit 2 with < or = 5 mm Hg difference between the eyes.
D.Corrected visual acuity in each eye of + 1.0 log MAR or better by ETDRS in each eye (equivalent to 20/200 or better).

Exclusion Criteria

A.Known allergy, hypersensitivity, or intolerance to study medication or its components or to topical anesthetics.

B.Previous glaucoma intraocular surgery in either eye. This does not include previous laser surgery.

C.Known lack of ocular hypotensive response to topical ophthalmic prostaglandin analogs or prostamides (in the opinion of the investigator).

D.Refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.) in either eye.

E.Other forms of primary (e.g., angle closure, congenital) or secondary glaucoma other than those noted in the Inclusion Criteria.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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