Trial Outcomes & Findings for Preservative-Free MK2452 (Tafluprost) for Open-Angle Glaucoma/Ocular Hypertension (MK2452-001)(COMPLETED) (NCT NCT01026831)
NCT ID: NCT01026831
Last Updated: 2017-06-21
Results Overview
IOP was measured using a Goldmann applanation tonometer. The primary evaluation was based on the study eye (the worse eye based on the 0800 hour IOP baseline or the right eye when both eyes had the same IOP). IOP change from baseline was calculated using the baseline IOP at each time point (0800 hours at baseline to 0800 hours at Week 2, 6, and 12; 1000 hours at baseline to 1000 hours at Week 2, 6, and 12; 1600 hours at baseline to 1600 hours at Week 2, 6, and 12). Lowering elevated IOP is a treatment goal of glaucoma.
COMPLETED
PHASE3
643 participants
Baseline, Weeks 2, 6, and 12.
2017-06-21
Participant Flow
Participant milestones
| Measure |
Tafluprost
One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
|
Timolol Maleate
One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
320
|
323
|
|
Overall Study
COMPLETED
|
306
|
312
|
|
Overall Study
NOT COMPLETED
|
14
|
11
|
Reasons for withdrawal
| Measure |
Tafluprost
One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
|
Timolol Maleate
One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
7
|
5
|
Baseline Characteristics
Preservative-Free MK2452 (Tafluprost) for Open-Angle Glaucoma/Ocular Hypertension (MK2452-001)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Tafluprost
n=320 Participants
One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
|
Timolol Maleate
n=323 Participants
One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
|
Total
n=643 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 11.7 • n=93 Participants
|
63.3 years
STANDARD_DEVIATION 11.6 • n=4 Participants
|
63.3 years
STANDARD_DEVIATION 11.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
183 Participants
n=93 Participants
|
192 Participants
n=4 Participants
|
375 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
137 Participants
n=93 Participants
|
131 Participants
n=4 Participants
|
268 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 2, 6, and 12.Population: The Per-Protocol (PP) approach excluded all patients with important protocol violations and was performed for the efficacy endpoints. The PP population excluded patients due to important deviations from the protocol that may have substantially affected the results of the primary endpoints.
IOP was measured using a Goldmann applanation tonometer. The primary evaluation was based on the study eye (the worse eye based on the 0800 hour IOP baseline or the right eye when both eyes had the same IOP). IOP change from baseline was calculated using the baseline IOP at each time point (0800 hours at baseline to 0800 hours at Week 2, 6, and 12; 1000 hours at baseline to 1000 hours at Week 2, 6, and 12; 1600 hours at baseline to 1600 hours at Week 2, 6, and 12). Lowering elevated IOP is a treatment goal of glaucoma.
Outcome measures
| Measure |
Tafluprost
n=299 Participants
One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
|
Timolol Maleate
n=313 Participants
One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
|
|---|---|---|
|
Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12)
Week 2 - 0800 (n=280; n=295)
|
-7.1 mmHg
Interval -7.5 to -6.8
|
-6.8 mmHg
Interval -7.1 to -6.5
|
|
Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12)
Week 2 - 1000 (n=293; n=305)
|
-6.8 mmHg
Interval -7.1 to -6.5
|
-6.1 mmHg
Interval -6.4 to -5.8
|
|
Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12)
Week 2 - 1600 (n=289; n=302)
|
-6.2 mmHg
Interval -6.5 to -5.9
|
-5.3 mmHg
Interval -5.7 to -5.0
|
|
Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12)
Week 6 - 0800 (n=294; n=308)
|
-7.3 mmHg
Interval -7.6 to -6.9
|
-7.4 mmHg
Interval -7.7 to -7.1
|
|
Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12)
Week 6 - 1000 (n=298; n=312)
|
-7.0 mmHg
Interval -7.3 to -6.7
|
-6.6 mmHg
Interval -6.9 to -6.3
|
|
Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12)
Week 6 - 1600 (n=295; n=310)
|
-6.3 mmHg
Interval -6.7 to -6.0
|
-5.5 mmHg
Interval -5.9 to -5.2
|
|
Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12)
Week 12 - 0800 (n=296; n=308)
|
-7.4 mmHg
Interval -7.8 to -7.1
|
-7.5 mmHg
Interval -7.8 to -7.1
|
|
Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12)
Week 12 - 1000 (n=298; n=312)
|
-7.0 mmHg
Interval -7.4 to -6.7
|
-6.6 mmHg
Interval -7.0 to -6.3
|
|
Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12)
Week 12 - 1600 (n=295; n=310)
|
-6.2 mmHg
Interval -6.5 to -5.9
|
-5.7 mmHg
Interval -6.0 to -5.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: The Per-Protocol (PP) approach excluded all patients with important protocol violations and was performed for the efficacy endpoints. The PP population excluded patients due to important deviations from the protocol that may have substantially affected the results of the primary endpoints.
IOP was measured using a Goldmann applanation tonometer. The primary evaluation was based on the study eye (the worse eye based on the 0800 hour IOP baseline or the right eye when both eyes had the same IOP).
Outcome measures
| Measure |
Tafluprost
n=299 Participants
One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
|
Timolol Maleate
n=313 Participants
One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
|
|---|---|---|
|
Baseline IOP
Baseline 1000 timepoint (n=299; n=313)
|
24.8 mmHg
Interval 24.5 to 25.2
|
24.6 mmHg
Interval 24.2 to 24.9
|
|
Baseline IOP
Baseline 0800 timepoint (n=299; n=313)
|
26.1 mmHg
Interval 25.8 to 26.4
|
26.0 mmHg
Interval 25.7 to 26.2
|
|
Baseline IOP
Baseline 1600 timepoint (n=296; n=312)
|
23.8 mmHg
Interval 23.4 to 24.2
|
23.5 mmHg
Interval 23.2 to 23.9
|
Adverse Events
Tafluprost
Timolol Maleate
Serious adverse events
| Measure |
Tafluprost
n=320 participants at risk
One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
|
Timolol Maleate
n=323 participants at risk
One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
|
|---|---|---|
|
Cardiac disorders
atrial fibrillation
|
0.31%
1/320 • Number of events 1
|
0.31%
1/323 • Number of events 1
|
|
Cardiac disorders
myocardial infarction
|
0.31%
1/320 • Number of events 1
|
0.00%
0/323
|
|
Eye disorders
retinal detachment
|
0.00%
0/320
|
0.31%
1/323 • Number of events 1
|
|
Gastrointestinal disorders
colitis
|
0.00%
0/320
|
0.31%
1/323 • Number of events 1
|
|
General disorders
hernia
|
0.00%
0/320
|
0.31%
1/323 • Number of events 1
|
|
Injury, poisoning and procedural complications
fracture
|
0.00%
0/320
|
0.31%
1/323 • Number of events 1
|
|
Injury, poisoning and procedural complications
joint dislocation
|
0.00%
0/320
|
0.31%
1/323 • Number of events 1
|
|
Injury, poisoning and procedural complications
tendon rupture
|
0.00%
0/320
|
0.31%
1/323 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.00%
0/320
|
0.31%
1/323 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
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