Trial Outcomes & Findings for MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension (0507A-149)(COMPLETED) (NCT NCT00449956)
NCT ID: NCT00449956
Last Updated: 2017-06-20
Results Overview
Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
474 participants
Primary outcome timeframe
8 weeks
Results posted on
2017-06-20
Participant Flow
Phase III. Studied period: April 9, 2007 (date study therapy started for the first subject) to February 16, 2008 (the last subject's last visit stipulated in study protocol). Study was conducted at 67 clinical sites.
Outpatients with primary open angle glaucoma (broad definition) and/or ocular hypertension received 4-week timolol 0.5% monotherapy in the wash-out period before the study randomization.
Participant milestones
| Measure |
MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)
MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
|
Timolol 0.5%
Timolol 0.5%, one drop per dose twice daily to the study eye.
|
Concomitant (Dorzolamide 1.0% / Timolol 0.5%)
Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
|
|---|---|---|---|
|
Overall Study
STARTED
|
189
|
92
|
193
|
|
Overall Study
COMPLETED
|
179
|
88
|
184
|
|
Overall Study
NOT COMPLETED
|
10
|
4
|
9
|
Reasons for withdrawal
| Measure |
MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)
MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
|
Timolol 0.5%
Timolol 0.5%, one drop per dose twice daily to the study eye.
|
Concomitant (Dorzolamide 1.0% / Timolol 0.5%)
Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
7
|
1
|
6
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
1
|
1
|
Baseline Characteristics
MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension (0507A-149)(COMPLETED)
Baseline characteristics by cohort
| Measure |
MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)
n=189 Participants
MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
|
Timolol 0.5%
n=92 Participants
Timolol 0.5%, one drop per dose twice daily to the study eye.
|
Concomitant (Dorzolamide 1.0% / Timolol 0.5%)
n=193 Participants
Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
|
Total
n=474 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.2 Years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
61.3 Years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
62.3 Years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
62.4 Years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
|
Age, Customized
<65 years
|
92 participants
n=5 Participants
|
50 participants
n=7 Participants
|
102 participants
n=5 Participants
|
244 participants
n=4 Participants
|
|
Age, Customized
>=65 years
|
97 participants
n=5 Participants
|
42 participants
n=7 Participants
|
91 participants
n=5 Participants
|
230 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
245 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
229 Participants
n=4 Participants
|
|
Diagnosis
Open-angle glaucoma
|
107 participants
n=5 Participants
|
51 participants
n=7 Participants
|
90 participants
n=5 Participants
|
248 participants
n=4 Participants
|
|
Diagnosis
Normal-tension glaucoma
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Diagnosis
Ocular hypertension
|
74 participants
n=5 Participants
|
35 participants
n=7 Participants
|
99 participants
n=5 Participants
|
208 participants
n=4 Participants
|
|
Intraocular pressure (IOP) at Hour 2
|
20.54 mmHg
STANDARD_DEVIATION 2.07 • n=5 Participants
|
20.23 mmHg
STANDARD_DEVIATION 1.85 • n=7 Participants
|
20.38 mmHg
STANDARD_DEVIATION 2.31 • n=5 Participants
|
20.42 mmHg
STANDARD_DEVIATION 2.13 • n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Last observed value during the 8-week treatment period was used in the Full Analysis Set (FAS).
Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)
Outcome measures
| Measure |
MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)
n=185 Participants
MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
|
Timolol 0.5%
n=90 Participants
Timolol 0.5%, one drop per dose twice daily to the study eye.
|
Concomitant (Dorzolamide 1.0% / Timolol 0.5%)
n=188 Participants
Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
|
|---|---|---|---|
|
Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks
|
-2.50 mmHg
Interval -2.86 to -2.15
|
-1.82 mmHg
Interval -2.33 to -1.31
|
-2.78 mmHg
Interval -3.13 to -2.43
|
SECONDARY outcome
Timeframe: 8 WeeksPopulation: Last observed value during the 8-week treatment period was used in the FAS.
Percent Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)
Outcome measures
| Measure |
MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)
n=185 Participants
MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
|
Timolol 0.5%
n=90 Participants
Timolol 0.5%, one drop per dose twice daily to the study eye.
|
Concomitant (Dorzolamide 1.0% / Timolol 0.5%)
n=188 Participants
Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
|
|---|---|---|---|
|
Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks
|
-11.99 Percent Change
Interval -13.69 to -10.28
|
-8.74 Percent Change
Interval -11.18 to -6.3
|
-13.46 Percent Change
Interval -15.15 to -11.77
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Last observed value during the 8-week treatment period was used in the FAS.
Percent Change from baseline to 8 weeks in Outflow Pressure Reduction Rate assessed 2 hours after ocular instillation (at Hour 2)
Outcome measures
| Measure |
MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)
n=185 Participants
MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
|
Timolol 0.5%
n=90 Participants
Timolol 0.5%, one drop per dose twice daily to the study eye.
|
Concomitant (Dorzolamide 1.0% / Timolol 0.5%)
n=188 Participants
Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
|
|---|---|---|---|
|
Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks
|
23.47 Percent Change
Interval 20.07 to 26.88
|
17.17 Percent Change
Interval 12.29 to 22.05
|
26.75 Percent Change
Interval 23.37 to 30.12
|
Adverse Events
MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)
Serious events: 2 serious events
Other events: 36 other events
Deaths: 0 deaths
Timolol 0.5%
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Concomitant (Dorzolamide 1.0% / Timolol 0.5%)
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)
MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
|
Timolol 0.5%
Timolol 0.5%, one drop per dose twice daily to the study eye.
|
Concomitant (Dorzolamide 1.0% / Timolol 0.5%)
Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
|
|---|---|---|---|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.53%
1/189
|
0.00%
0/92
|
0.00%
0/193
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/189
|
1.1%
1/92
|
0.00%
0/193
|
|
Nervous system disorders
Cerebral infarction
|
0.53%
1/189
|
0.00%
0/92
|
0.00%
0/193
|
Other adverse events
| Measure |
MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)
MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
|
Timolol 0.5%
Timolol 0.5%, one drop per dose twice daily to the study eye.
|
Concomitant (Dorzolamide 1.0% / Timolol 0.5%)
Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
|
|---|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
1.6%
3/189
|
1.1%
1/92
|
2.1%
4/193
|
|
Eye disorders
Corneal epithelium defect
|
1.1%
2/189
|
2.2%
2/92
|
2.6%
5/193
|
|
Eye disorders
Punctate keratitis
|
1.6%
3/189
|
0.00%
0/92
|
3.1%
6/193
|
|
General disorders
Instillation site irritation
|
6.9%
13/189
|
0.00%
0/92
|
3.6%
7/193
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
5/189
|
3.3%
3/92
|
4.1%
8/193
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.53%
1/189
|
1.1%
1/92
|
2.1%
4/193
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/189
|
2.2%
2/92
|
0.00%
0/193
|
|
Nervous system disorders
Headache
|
2.1%
4/189
|
0.00%
0/92
|
0.00%
0/193
|
|
Investigations
Alanine aminotransferase increased
|
2.1%
4/189
|
2.2%
2/91
|
2.6%
5/193
|
|
Investigations
Glucose urine present
|
2.6%
5/189
|
1.1%
1/91
|
4.7%
9/193
|
|
Investigations
Blood urine present
|
1.5%
3/198
|
3.3%
3/91
|
0.00%
0/193
|
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