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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 February 2021
• Main ID: NCT00647101
• Date of registration: 26/03/2008
• Prospective Registration: No
• Primary sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Public title: 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
• Scientific title: Open Multicenter Study on the Efficacy of Xalatan at 3 Months as First-line Therapy in Naive Patients With Ocular Hypertension (OH) or Open Angle Glaucoma (OAG), Based on Initial Intraocular Pressure (IOP): 20 mmHg Less Than or Equal to IOP Less Than 24 mmHg, IOP Greater Than or Equal to 24 mmHg
• Date of first enrolment: December 2003
• Target sample size: 600
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00647101
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Glaucoma, Open-Angle

Ocular Hypertension

Intervention(s)

Drug: Latanoprost

Primary Outcome(s)

Change in IOP after 3 months of treatment in absolute values (mmHg) compared to baseline IOP [Time Frame: 3 months]

Secondary Outcome(s)

Occurrence of adverse events on latanoprost, local tolerability analysis by clinical exam [Time Frame: 3 months]

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 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]

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 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]

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]

Secondary ID(s)

A6111002

X-FIL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors