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

Glaucoma Clinical Trial

Official title:

Prospective, Open-label, Single-arm Study to Evaluate Efficacy and Safety of Combination Therapy of Timolol and Dorzolamide (COSOPT) as Initial Treatment for Patients With Normal Tension Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00832377
• Other study ID #: 0507A-161
• Secondary ID: 2009_524
• Status: Completed
• Phase: Phase 2
• First received: January 29, 2009
• Last updated: August 31, 2017
• Start date: April 24, 2009
• Est. completion date: March 26, 2010

Study information

• Verified date: August 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 26, 2010
• Est. primary completion date: March 12, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Glaucoma
• Low Tension Glaucoma

Intervention

Drug:
• timolol/dorzolamide combination
Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Baseline IOP	Baseline IOP was measured at ~9 AM of first day of treatment period.; IOP was measured in both eyes and the eye with the higher IOP was used for the participant.	Baseline
Primary	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	Mean Change in Trough IOP Measured Right Before 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	Mean Change in IOP 8 Hours After the 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

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site