Trial Outcomes & Findings for Dry Eye Study With Cosopt® Over 8 Weeks in Patients With Open-Angle Glaucoma or Ocular Hypertension (0507A-152)(COMPLETED) (NCT NCT00545064)

Results Overview

GSS-SYMP-6 measures 6 non-visual adverse symptoms related to glaucoma medications, with 10 5-point Likert scale questions. Score ranges between 0 and 100, lower scores indicating higher symptoms severity. Change equals post-baseline value minus baseline.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

176 participants

Primary outcome timeframe

Baseline to week 8

Results posted on

2017-06-20

Participant Flow

First patient in: MAY-23-2007 Last patient out: OCT-15-2008 Total number of sites: 28 sites in Canada. (Study performed in Canada only).

Participant milestones

Participant milestones
Measure	Preservative-free Dorzolamide-timolol (COSOPT®) subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available).
Overall Study STARTED	178
Overall Study Visit 1 (Baseline)	178
Overall Study Visit 2 (Week 4)	169
Overall Study Visit 3 (Week 8)	176
Overall Study COMPLETED	170
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Preservative-free Dorzolamide-timolol (COSOPT®) subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available).
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	2
Overall Study did not complete course of treatment	1
Overall Study cancel all appointments, no rebooking	1
Overall Study inclement weather	1

Baseline Characteristics

Dry Eye Study With Cosopt® Over 8 Weeks in Patients With Open-Angle Glaucoma or Ocular Hypertension (0507A-152)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Preservative-free Dorzolamide-timolol (COSOPT®) n=178 Participants subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available).
Age, Continuous	65.6 years STANDARD_DEVIATION 12.1 • n=99 Participants
Sex: Female, Male Female	90 Participants n=99 Participants
Sex: Female, Male Male	88 Participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline to week 8

Population: 176 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. Observations on GSS-SYMP-6 were available for 114 and 111 patients at week 4 and 8 respectively

GSS-SYMP-6 measures 6 non-visual adverse symptoms related to glaucoma medications, with 10 5-point Likert scale questions. Score ranges between 0 and 100, lower scores indicating higher symptoms severity. Change equals post-baseline value minus baseline.

Outcome measures

Outcome measures
Measure	Preservative-free Dorzolamide-timolol (COSOPT®) Week 4 n=114 Participants	Preservative-free Dorzolamide-timolol (COSOPT®) Week 8 n=111 Participants
Change in Glaucoma Symptom Scale (GSS)-SYMP-6 Score	1.7 Units on a Scale Standard Deviation 16.8	3.2 Units on a Scale Standard Deviation 20.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 8

Population: 178 - number of patients that signed the consent form and received at least one dose of study medication. The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristics were available).

At week 8, patients were asked to complete a single question describing how satisfied they were regarding with their medication, on a 5-level scale: very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, very dissatisfied.

Outcome measures

Outcome measures
Measure	Preservative-free Dorzolamide-timolol (COSOPT®) Week 4 n=170 Participants	Preservative-free Dorzolamide-timolol (COSOPT®) Week 8
Patient's Global Satisfaction Very Satisfied	79 Participants	—
Patient's Global Satisfaction Satisfied	65 Participants	—
Patient's Global Satisfaction Neither Satisfied or Dissatisfied	11 Participants	—
Patient's Global Satisfaction Dissatisfied	6 Participants	—
Patient's Global Satisfaction Very Dissatisfied	3 Participants	—
Patient's Global Satisfaction Missing	6 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 8

Population: 178 - number of patients that signed the consent form and received at least one dose of study medication. The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristics were available).

At week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient's treatment, on a 5-level scale: very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, very dissatisfied.

Outcome measures

Outcome measures
Measure	Preservative-free Dorzolamide-timolol (COSOPT®) Week 4 n=170 Participants	Preservative-free Dorzolamide-timolol (COSOPT®) Week 8
Physician's Global Satisfaction Very Satisfied	130 Participants	—
Physician's Global Satisfaction Satisfied	52 Participants	—
Physician's Global Satisfaction Neither Satisfied or Dissatisfied	5 Participants	—
Physician's Global Satisfaction Dissatisfied	5 Participants	—
Physician's Global Satisfaction Very Dissatisfied	2 Participants	—
Physician's Global Satisfaction Missing	3 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 4 and from Baseline to Week 8

Population: 176 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. Observations on IOP were available for 164 and 166 patients at week 4 and 8 respectively

IOP measurements using Goldmann applanation tonometry, performed by a masked physician two hours after patient was administered study medication. Change is computed as week 4 (or week 8) value minus baseline value.

Outcome measures

Outcome measures
Measure	Preservative-free Dorzolamide-timolol (COSOPT®) Week 4 n=164 Participants	Preservative-free Dorzolamide-timolol (COSOPT®) Week 8 n=166 Participants
Change in Intra-ocular Pressure (IOP) for Worse Eye From Baseline to Week 4 and From Baseline to Week 8, in Patients Receiving Preservative-free Dorzolamide-timolol	-11.7 mm Hg Standard Deviation 5.1	-11.5 mm Hg Standard Deviation 5.3

Adverse Events

Preservative-free Dorzolamide-timolol (COSOPT®)

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Preservative-free Dorzolamide-timolol (COSOPT®) n=178 participants at risk subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available).
Cardiac disorders Cardiac disorders	0.56% 1/178 • Number of events 1 As per protocol only Serious Adverse Events were systematically reported. The 0/0 indicates that Other (Not Including Serious) Adverse Events were not collected as per protocol.
Gastrointestinal disorders Gastrointestinal disorders	0.56% 1/178 • Number of events 1 As per protocol only Serious Adverse Events were systematically reported. The 0/0 indicates that Other (Not Including Serious) Adverse Events were not collected as per protocol.
Eye disorders Eye disorders	0.56% 1/178 • Number of events 1 As per protocol only Serious Adverse Events were systematically reported. The 0/0 indicates that Other (Not Including Serious) Adverse Events were not collected as per protocol.

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

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