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

Phase 4

Completed

• Conditions: Glaucoma, Open-Angle; Ocular Hypertension
• Interventions: Drug: Latanoprost

• Registration Number: NCT00647101
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study Completion: 2005-02
• Status Verified: 2008-03
• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-28
• Study First Posted: 2008-03-31
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Latanoprost group	Latanoprost	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in IOP after 3 months of treatment in relative values (percentage of decrease) compared to baseline IOP	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%	3 months
Change in IOP after 1 month of treatment in absolute (mmHg) and relative values (percentage of decrease) relative to baseline IOP	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%	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	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	1 month
Occurrence of adverse events on latanoprost, local tolerability analysis by clinical exam	3 months

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇫🇷 Wattrelos, France