COSOPT (Timolol/Dorzolamide Combination) Normal Tension Glaucoma Study (MK0507A-161)(COMPLETED)

NCT00832377 | Completed Phase 2 Results

• 2 other identifiers: 0507A-1612009_524
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study to evaluate the effect of the 12-week treatment with timolol/dorzolamide combination eyedrops (COSOPT) on decrease in intraocular pressure (IOP) at 2 hours after the study drug administration

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP.

  The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement. IOP was measured in both eyes and the eye with the higher IOP was used for the participant.

  Baseline and 12 weeks

Secondary Outcomes (2)

• Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP.

  Baseline and 12 weeks

• Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP

  Baseline and 12 weeks

Other Outcomes (1)

• Baseline IOP

  Baseline

Study Arms (1)

Timolol/Dorzolamide

EXPERIMENTAL

Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks

Drug: timolol/dorzolamide combination

Interventions

timolol/dorzolamide combination DRUG

Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks

Also known as: Cosopt

Timolol/Dorzolamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have not been treated with a glaucoma medication within 6 weeks prior to study participation after diagnosis with primary open-angle glaucoma
• Patients with primary open-angle glaucoma based on gonioscopy
• Patients with normal tension glaucoma diagnosed based on accompanying optic disc cupping and reappearance of visual field defect corresponding to retinal nerve fiber layer defect.
• Subjects with \< 22 mm Hg of diurnal IOP measured using Goldmann applanation tonometer (every two hours between 9 a.m. and 5 p.m.)

You may not qualify if:

• Patients with another type of glaucoma but primary open-angle glaucoma
• Patients treated with other glaucoma medications within 6 weeks prior to study participation
• Patients with a history of chronic ocular inflammation or recurrent ocular inflammation
• Patients using contact lenses
• Patients who are allergic to timolol or dorzolamide
• Patients with a history of any of the following COSOPT (timolol/dorzolamide combination) contraindications:
• Reactive airway diseases
• Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock
• Severe renal impairment
• Patients with a history of significant ocular trauma or intraocular surgery within 6 months before participating the study, or intraocular laser surgery within 3 months before the participating the study
• Patients with a history of a corneal disease
• Patients who are using steroid or used the drug for more than 2 weeks within 12 months before participating the study
• Pregnant women

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Kim TW, Kim M, Lee EJ, Jeoung JW, Park KH. Intraocular pressure-lowering efficacy of dorzolamide/timolol fixed combination in normal-tension glaucoma. J Glaucoma. 2014 Jun-Jul;23(5):329-32. doi: 10.1097/IJG.0b013e3182741f4d.

  PMID: 23377586 RESULT

MeSH Terms

Conditions

Glaucoma

Interventions

dorzolamide-timolol combination

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2009
• First Posted: January 30, 2009
• Study Start: April 24, 2009
• Primary Completion: March 12, 2010
• Study Completion: March 26, 2010
• Last Updated: September 29, 2017
• Results First Posted: March 24, 2011

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share