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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00108017
Enrollment
330
Registered
2005-04-13
Start date
2005-04-30
Completion date
2006-07-31
Last updated
2015-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Ocular Hypertension

Keywords

Ocular hypertension (excessive pressure in the eye)

Brief summary

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

Interventions

DRUGMK0507A, dorzolamide hydrochloride (+) timolol maleate
DRUGDuration of Treatment: Part 1) 6 wk timolol maleate run in
DRUGPart 2) 6 wk washout pd Part 3) two 8 wk active tx pds

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
24 hour diurnal IOP reduction after 8 weeks of treatmentAfter 8 weeks of treatment

Secondary

MeasureTime frame
IOP reduction a) from baseline at 6 weeks; b) comparison with timolol; c) comparison day versus nightAt 6 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026