NCT00832377

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

Completed Phase 2 Results posted Last updated 29 September 2017

What this trial tests

Phase 2 trial testing timolol/dorzolamide combination in Glaucoma in 37 participants. Completed in 26 March 2010.

Timeline

24 April 2009

Primary endpoint
12 March 2010

26 March 2010

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	24 April 2009
Primary completion	12 March 2010
Estimated completion	26 March 2010

Drugs / interventions tested

• timolol/dorzolamide combination — full drug profile →

Conditions studied

• Glaucoma — all drugs for Glaucoma →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, any sex, with Glaucoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

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.

Group	Value	95% CI
Timolol/Dorzolamide	-3.73	± 2.28

Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP. Secondary · Baseline and 12 weeks

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.

Group	Value	95% CI
Timolol/Dorzolamide	-3.22	± 2.14

Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP Secondary · Baseline and 12 weeks

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.

Group	Value	95% CI
Timolol/Dorzolamide	-3.78	± 2.40

Baseline IOP Secondary · Baseline

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.

Group	Value	95% CI
Timolol/Dorzolamide	15.60	± 2.46

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Timolol/Dorzolamide

Serious: 0/37 (0%)

Deaths: —

Other adverse events (5 terms — click to expand)

Reaction	System	Timolol/Dorzolamide
Eye irritation	Eye disorders	—
Ocular hyperaemia	Eye disorders	—
Back pain	Musculoskeletal and connective tissue disorders	—
Headache	Nervous system disorders	—
Rash	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT00832377 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.