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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00108017
• Other study ID #: 0507A-137
• Secondary ID: 2005_021
• Status: Completed
• Phase: Phase 3
• First received: April 12, 2005
• Last updated: May 12, 2015
• Start date: April 2005
• Est. completion date: July 2006

Study information

• Verified date: May 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• MK0507A, dorzolamide hydrochloride (+) timolol maleate

• Comparator: timolol maleate

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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (2)

Feldman RM, Stewart RH, Stewart WC, Jia G, Smugar SS, Galet VA. 24-hour control of intraocular pressure with 2% dorzolamide/0.5% timolol fixed-combination ophthalmic solution in open-angle glaucoma. Curr Med Res Opin. 2008 Aug;24(8):2403-12. doi: 10.1185/03007990802243366. Epub 2008 Jul 14. — View Citation

Olander KW, Galet VA, Jia G, Smugar SS, Stewart WC. Relationship between visual field severity and response to fixed combination dorzolamide/timolol or timolol alone. J Ocul Pharmacol Ther. 2009 Aug;25(4):357-64. doi: 10.1089/jop.2008.0104. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour diurnal IOP reduction after 8 weeks of treatment		After 8 weeks of treatment	No
Secondary	IOP reduction a) from baseline at 6 weeks; b) comparison with timolol; c) comparison day versus night		At 6 weeks	No