Comparison of the Effects of Two Glaucoma Drugs Over 24 Hours (0507A-137)(COMPLETED)
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ClinicalTrials.gov Identifier: NCT00108017 |
Recruitment Status :
Completed
First Posted : April 13, 2005
Last Update Posted : May 13, 2015
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Condition or disease | Intervention/treatment | Phase |
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Glaucoma Ocular Hypertension | Drug: 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 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 330 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official 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 |
Study Start Date : | April 2005 |
Actual Primary Completion Date : | July 2006 |
Actual Study Completion Date : | July 2006 |
- 24 hour diurnal IOP reduction after 8 weeks of treatment [ Time Frame: After 8 weeks of treatment ]
- IOP reduction a) from baseline at 6 weeks; b) comparison with timolol; c) comparison day versus night [ Time Frame: At 6 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108017
Study Director: | Medical Monitor | Merck Sharp & Dohme LLC |
Responsible Party: | Merck Sharp & Dohme LLC |
ClinicalTrials.gov Identifier: | NCT00108017 |
Other Study ID Numbers: |
0507A-137 2005_021 |
First Posted: | April 13, 2005 Key Record Dates |
Last Update Posted: | May 13, 2015 |
Last Verified: | May 2015 |
Ocular hypertension (excessive pressure in the eye) |
Glaucoma Ocular Hypertension Hypertension Vascular Diseases Cardiovascular Diseases Eye Diseases Timolol Dorzolamide Maleic acid Adrenergic beta-Antagonists |
Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents Enzyme Inhibitors Carbonic Anhydrase Inhibitors |