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OpenTrials
Completed

NCT Number: NCT00647101

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

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.

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Albi, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

latanoprost

Drug

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

Primary outcomes

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

    Time frame: 3 months

Secondary outcomes

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

    Time frame: 3 months

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

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

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2005
First posted
Mar 31, 2008
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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