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MK0507A Phase III Double-Blind, Comparative Study

Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma

Intervention: dorzolamide hydrochloride (+) timolol maleate (Drug); Comparator: timolol maleate (Drug); Comparator: dorzolamide hydrochloride (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

Summary

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.

Clinical Details

Official 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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Intraocular pressure reduction

Safety profile

Secondary outcome:

Intraocular pressure reduction rate

Outflow pressure reduction rate

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with glaucoma and ocular hypertension

Exclusion Criteria:

- History of ocular surgery within 3 months.

- Administration contradiction to timolol and dorzolamide.

Locations and Contacts

Additional Information

Starting date: March 2007
Last updated: March 5, 2008

Page last updated: June 20, 2008

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