Trial Outcomes & Findings for Assessment of Intraocular Pressure (IOP) Control in Subjects With Open-Angle Glaucoma or Ocular Hypertension Treated With Travoprost 0.004% (TRAVATAN® Z) or Bimatoprost 0.01% (LUMIGAN®) (NCT NCT01464424)
NCT ID: NCT01464424
Last Updated: 2013-09-13
Results Overview
IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm) for an overall mean. The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye. Per-protocol dataset was pre-specified for this non-inferiority analysis.
COMPLETED
PHASE4
84 participants
Week 6
2013-09-13
Participant Flow
Subjects were recruited from 2 study centers located in the US.
This reporting group includes all enrolled subjects. A washout-period based on prior medication preceded Period 1 dispense.
Participant milestones
| Measure |
TRAVATAN, Then LUMIGAN
Travoprost 0.004% ophthalmic solution (TRAVATAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by bimatoprost 0.01% ophthalmic solution (LUMIGAN), same dose, same duration, as randomized, for a total duration of 12 weeks
|
LUMIGAN, Then TRAVATAN
Bimatoprost 0.01% ophthalmic solution (LUMIGAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by travoprost 0.004% ophthalmic solution (TRAVATAN), same dose, same duration, as randomized, for a total duration of 12 weeks
|
|---|---|---|
|
Period 1, First 6 Weeks
STARTED
|
42
|
42
|
|
Period 1, First 6 Weeks
COMPLETED
|
42
|
41
|
|
Period 1, First 6 Weeks
NOT COMPLETED
|
0
|
1
|
|
Period 2, Second 6 Weeks
STARTED
|
42
|
41
|
|
Period 2, Second 6 Weeks
COMPLETED
|
42
|
41
|
|
Period 2, Second 6 Weeks
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
TRAVATAN, Then LUMIGAN
Travoprost 0.004% ophthalmic solution (TRAVATAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by bimatoprost 0.01% ophthalmic solution (LUMIGAN), same dose, same duration, as randomized, for a total duration of 12 weeks
|
LUMIGAN, Then TRAVATAN
Bimatoprost 0.01% ophthalmic solution (LUMIGAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by travoprost 0.004% ophthalmic solution (TRAVATAN), same dose, same duration, as randomized, for a total duration of 12 weeks
|
|---|---|---|
|
Period 1, First 6 Weeks
Adverse Event
|
0
|
1
|
Baseline Characteristics
Assessment of Intraocular Pressure (IOP) Control in Subjects With Open-Angle Glaucoma or Ocular Hypertension Treated With Travoprost 0.004% (TRAVATAN® Z) or Bimatoprost 0.01% (LUMIGAN®)
Baseline characteristics by cohort
| Measure |
Overall
n=84 Participants
Travoprost 0.004% and bimatoprost 0.01% in cross-over fashion, as randomized, 6 weeks each
|
|---|---|
|
Age Continuous
|
58.7 years
STANDARD_DEVIATION 11.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
84 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 6Population: Per protocol: All subjects who received study medication, completed all study visits as per the protocol timelines and criteria, and satisfied inclusion/exclusion criteria.
IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm) for an overall mean. The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye. Per-protocol dataset was pre-specified for this non-inferiority analysis.
Outcome measures
| Measure |
TRAVATAN
n=81 Participants
Travoprost 0.004% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
|
LUMIGAN
n=81 Participants
Bimatoprost 0.01% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
|
|---|---|---|
|
Overall Mean Intraocular Pressure (IOP)
|
17.45 millimeters mercury (mmHg)
Standard Deviation 2.664
|
17.22 millimeters mercury (mmHg)
Standard Deviation 2.605
|
SECONDARY outcome
Timeframe: Week 6: 4 pm, 6 pm, 8 pmPopulation: Per protocol: All subjects who received study medication, completed all study visits as per the protocol timelines and criteria, and satisfied inclusion/exclusion criteria.
IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm). The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye.
Outcome measures
| Measure |
TRAVATAN
n=81 Participants
Travoprost 0.004% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
|
LUMIGAN
n=81 Participants
Bimatoprost 0.01% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
|
|---|---|---|
|
Mean IOP at Each After Office Hour Evaluation Timepoint
4 pm (20 hours post dose)
|
17.74 millimeters mercury (mmHg)
Standard Deviation 3.099
|
17.08 millimeters mercury (mmHg)
Standard Deviation 2.808
|
|
Mean IOP at Each After Office Hour Evaluation Timepoint
6 pm (22 hours post dose)
|
17.52 millimeters mercury (mmHg)
Standard Deviation 2.836
|
17.32 millimeters mercury (mmHg)
Standard Deviation 3.055
|
|
Mean IOP at Each After Office Hour Evaluation Timepoint
8 pm (24 hours post dose)
|
17.06 millimeters mercury (mmHg)
Standard Deviation 2.840
|
17.26 millimeters mercury (mmHg)
Standard Deviation 2.890
|
Adverse Events
TRAVATAN
LUMIGAN
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Doug Hubatsch, Global Brand Leader, Medical Affairs
Alcon Research, Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER