Trial Outcomes & Findings for COSOPT (Timolol/Dorzolamide Combination) Normal Tension Glaucoma Study (MK0507A-161)(COMPLETED) (NCT NCT00832377)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

37 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2017-09-29

Participant Flow

44 participants were actually screened. Among them, 7 participants failed in screening (2 participants withdrew and 5 did not meet eligibility criteria). Therefore 37 participants were considered to have enrolled.

Participant milestones

Participant milestones
Measure	Timolol/Dorzolamide Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
Overall Study STARTED	37
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Timolol/Dorzolamide Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
Overall Study Protocol Violation	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Timolol/Dorzolamide n=37 Participants Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
Age, Continuous	56.6 years STANDARD_DEVIATION 10.92 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Timolol/Dorzolamide n=36 Participants Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
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 Standard Deviation 2.28

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Timolol/Dorzolamide n=36 Participants Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP.	-3.22 mmHg Standard Deviation 2.14

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Timolol/Dorzolamide n=36 Participants Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP	-3.78 mmHg Standard Deviation 2.40

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Timolol/Dorzolamide n=36 Participants Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
Baseline IOP	15.60 mmHg Standard Deviation 2.46

Adverse Events

Timolol/Dorzolamide

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Timolol/Dorzolamide n=37 participants at risk Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
Eye disorders Eye irritation	59.5% 22/37 • Number of events 32
Eye disorders Ocular hyperaemia	16.2% 6/37 • Number of events 6
Musculoskeletal and connective tissue disorders Back pain	5.4% 2/37 • Number of events 2
Nervous system disorders Headache	5.4% 2/37 • Number of events 2
Skin and subcutaneous tissue disorders Rash	5.4% 2/37 • Number of events 2

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER