A Study Comparing The Efficacy, Safety And Tolerability Of Latanoprost 75, 100 And 125 ug/ml To Xalatan In The Treatment Of Primary Open-Angle Glaucoma And Ocular Hypertension

• Status: Completed
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study was to compare the change in intraocular pressure (IOP) of three different doses of latanoprost (75, 100 and 125 ug/ml) to that of the marketed 50 ug/ml dose, in a dose ranging study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Latanoprost

Criteria

Inclusion Criteria:

• Male or female, 18 years of age or older.

• Primary open angle glaucoma (POAG) or ocular hypertension (OHT) requiring unilateral or bilateral administration of intraocular pressure (IOP) lowering treatment, including patients who were naïve to IOP lowering treatment.

• IOP between ≥ 24 mmHg and ≤ 36 mmHg in at least one eye at the 8 AM time point at baseline/randomization.

Exclusion Criteria:

• Closed/barely open anterior chamber angle or a history of acute angle closure.

• A history of discontinued prostaglandin IOP lowering treatment, unless the reason for discontinuation was participation in a clinical study.

• Ocular surgery or argon laser trabeculoplasty in one or both eyes within 3 months prior to the screening visit.

• Use or anticipated requirement during the study of any topical medication that was known to affect IOP.

• Anticipated need to modify systemic medication known to affect IOP (eg, beta-adrenergic antagonists, alpha-adrenergic agonists, calcium channel blockers, angiotension converting enzyme inhibitors, and angiotension II receptor antagonists) during the study period.