A Study to Assess the Efficacy of 3 Months of Latanoprost Treatment in Reducing the Intraocular Pressure in Patients With Ocular Hypertension or Open-angle Glaucoma

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.600 enrolled

Overview

The purpose of this study is to evaluate the effect of latanoprost on intraocular pressure reduction in patients with ocular hypertension or open-angle glaucoma.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

600

Conditions

Glaucoma, Open-Angle Ocular Hypertension

Interventions

LatanoprostDRUG

Latanoprost 0.005% drops: 1 drop in the diseased eye(s) in the evening for 3 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A patient with an IOP greater than or equal to 20 mmHg related to unilateral or bilateral OH or OAG (primary open angle glaucoma, pseudo-exfoliative glaucoma, and pigmentary glaucoma), after a visual field exam * Naive patients (i.e. never having been treated) and requiring treatment initiation Exclusion Criteria: * A patient with OH or OAG currently on treatment * A patient with OH or OAG previously treated (regardless of the date treatment was discontinued) * A patient with traumatic, inflammatory, or neovascular glaucoma

Locations (176)

Outcomes

Primary Outcomes

Change in IOP after 3 months of treatment in absolute values (mmHg) compared to baseline IOP

Time frame: 3 months

Secondary Outcomes

Change in IOP after 3 months of treatment in relative values (percentage of decrease) compared to baseline IOP

Time frame: 3 months

Proportion of patients after 3 months of treatment with a relative reduction in IOP of greater than or equal to 30%, and greater than or equal to 10%

Time frame: 3 months

Change in IOP after 1 month of treatment in absolute (mmHg) and relative values (percentage of decrease) relative to baseline IOP

Time frame: 1 month

Proportion of patients after 1 month of treatment with a relative reduction in IOP of greater than or equal to 30%, and greater than or equal to 10%

Time frame: 1 month

Proportion of patients after 3 months of treatment achieving the following target IOP values: IOP less than or equal to 21 mmHg, IOP less than or equal to 18 mmHg, IOP less than or equal to 15 mmHg

Time frame: 3 months

Proportion of patients after 1 month of treatment achieving the following target IOP values: IOP less than or equal to 21 mmHg, IOP less than or equal to 18 mmHg, IOP less than or equal to 15 mmHg

Time frame: 1 month

Occurrence of adverse events on latanoprost, local tolerability analysis by clinical exam

Time frame: 3 months

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Albi, France

Pfizer Investigational Site

Ambert, France

Pfizer Investigational Site

Amboise, France

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Angers, France

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Antibes, France

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Aubenas, France

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Belfort, France

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Bergerac, France

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Bernay, France

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Béthune, France

...and 166 more locations