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

Viatris

Status and phase: Completed; Phase 2

Conditions: Ocular Hypertension; Primary Open Angle Glaucoma

Treatments: Drug: latanoprost 75 ug; Drug: latanoprost 100 ug; Drug: latanoprost 50 ug; Drug: latanoprost 125 ug

Study type: Interventional

Funder types: Industry

Identifiers

NCT01379144

A6111066

XALA-0091-166

Details and patient eligibility

About

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.

Enrollment: 282 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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282 participants in 4 patient groups

latanoprost 75 ug

Experimental group

Treatment:

Drug: latanoprost 75 ug

latanoprost 100 ug

Experimental group

Treatment:

Drug: latanoprost 100 ug

latanoprost 125 ug

Experimental group

Treatment:

Drug: latanoprost 125 ug

latanoprost 50 ug

Active Comparator group

Treatment:

Drug: latanoprost 50 ug