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OpenTrials
Completed

NCT Number: NCT00108017

Comparison of the Effects of Two Glaucoma Drugs Over 24 Hours (0507A-137)(COMPLETED)

This study is comparing 2 medications for glaucoma and how effective they are at controlling glaucoma over the course of an entire day.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 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 or ocular hypertension

Exclusion criteria

  • Other eye conditions
  • Poor vision
  • Recent eye surgery
  • Use of contact lenses
  • Nursing or pregnant women
  • Use of some other selected medications
  • Drug or alcohol abuse
  • Asthma
  • Slow heart beat
  • Allergy or previous reaction to study drugs

Treatment and study plan

MK0507A, dorzolamide hydrochloride (+) timolol maleate

Drug

Comparator: timolol maleate

Drug

Duration of Treatment: Part 1) 6 wk timolol maleate run in

Drug

Part 2) 6 wk washout pd Part 3) two 8 wk active tx pds

Drug

Primary outcomes

  1. 24 hour diurnal IOP reduction after 8 weeks of treatment

    Time frame: After 8 weeks of treatment

Secondary outcomes

  1. IOP reduction a) from baseline at 6 weeks; b) comparison with timolol; c) comparison day versus night

    Time frame: At 6 weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Randomized, Multicenter, Dbl-Masked, Parallel Study Evaluating the 24 Hr. Diurnal Ocular Hypotensive Effect of 2% Dorzolamide Hydrochloride/0.5% Timolol Maleate Combo. Ophthalmic Sol. in Patients w/ Open Angle Glaucoma or Ocular Hypertension

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Apr 13, 2005
Registry last updated
May 13, 2015

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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