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Completed

NCT Number: NCT00449956

MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension (0507A-149)(COMPLETED)

The clinical study compares safety and efficacy of MK0507A (dorzolamide 1.0% / timolol 0.5%) with 1) timolol 0.5% and with 2) concomitant therapy with dorzolamide 1.0% / timolol 0.5% in patients with glaucoma and ocular hypertension.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with glaucoma and ocular hypertension

Exclusion criteria

  • History of ocular surgery within 3 months
  • Administration contradiction to timolol and dorzolamide

Treatment and study plan

dorzolamide hydrochloride (+) timolol maleate

Drug

Dorzolamide hydrochloride 1% + timolol 0.5%, 8-week

Comparator: timolol maleate

Drug

timolol maleate 0.5%, 8-week

Comparator: dorzolamide hydrochloride

Drug

dorzolamide hydrochloride 1%, 8-week

Primary outcomes

  1. Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks

    Time frame: 8 weeks

    Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)

Secondary outcomes

  1. Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks

    Time frame: 8 Weeks

    Percent Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)

  2. Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks

    Time frame: 8 weeks

    Percent Change from baseline to 8 weeks in Outflow Pressure Reduction Rate assessed 2 hours after ocular instillation (at Hour 2)

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Multicenter, Double-Blind, Active Comparator-controlled Study to Evaluate the Safety and Efficacy of MK0507A in Patients With Glaucoma and Ocular Hypertension Who Are Inadequately Controlled on Beta-Blockers

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 21, 2007
Registry last updated
Jun 20, 2017

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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