Phase 2 N=37 Treatment

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

Glaucoma

Bottom Line

View on ClinicalTrials.gov: NCT00832377 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2011

Primary outcome: Primary: Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP. — -3.73 mmHg — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: timolol/dorzolamide combination (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Mar 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP.	-3.73	<0.0001 sig
SECONDARY Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP.	-3.22	<0.0001 sig
SECONDARY Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP	-3.78	<0.0001 sig

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00832377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.