Clinical trial NCT00832377: COSOPT (Timolol/Dorzolamide Combination) Normal Tension Glaucoma Study (MK0507A-161)(COMPLETED)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-01-30
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP.
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP.
timeFrame: Baseline and 12 weeks
measure: Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Baseline IOP
timeFrame: Baseline
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.