Trial Outcomes & Findings for Comparing Safety and Efficacy of Combigan® and Lumigan® With Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated With Xalatan® (NCT NCT01170884)
NCT ID: NCT01170884
Last Updated: 2019-04-24
Results Overview
Mean Diurnal (average of 8 AM, 10 AM, and 4 PM time points) IOP at Week 12 in the study eye. IOP is a measurement of the fluid pressure inside the eye.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
121 participants
Primary outcome timeframe
Week 12
Results posted on
2019-04-24
Participant Flow
Participant milestones
| Measure |
Combigan® + Lumigan®
COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
|
Lumigan®
LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
62
|
|
Overall Study
COMPLETED
|
54
|
60
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Safety and Efficacy of Combigan® and Lumigan® With Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated With Xalatan®
Baseline characteristics by cohort
| Measure |
Combigan® + Lumigan®
n=59 Participants
COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
|
Lumigan®
n=62 Participants
LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 10.52 • n=5 Participants
|
62.6 years
STANDARD_DEVIATION 13.19 • n=7 Participants
|
63.3 years
STANDARD_DEVIATION 11.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Intent-to-Treat (ITT) included all subjects who were randomized to study medication.
Mean Diurnal (average of 8 AM, 10 AM, and 4 PM time points) IOP at Week 12 in the study eye. IOP is a measurement of the fluid pressure inside the eye.
Outcome measures
| Measure |
Combigan® + Lumigan®
n=59 Participants
COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
|
Lumigan®
n=62 Participants
LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
|
|---|---|---|
|
Mean Diurnal Intraocular Pressure (IOP) at Week 12
|
15.4 Millimeters of mercury (mm Hg)
Standard Deviation 2.34
|
19.2 Millimeters of mercury (mm Hg)
Standard Deviation 3.42
|
Adverse Events
Combigan® + Lumigan®
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Lumigan®
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Combigan® + Lumigan®
n=59 participants at risk
COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
|
Lumigan®
n=62 participants at risk
LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
|
|---|---|---|
|
Eye disorders
Foreign Body Sensation
|
5.1%
3/59
|
0.00%
0/62
|
|
Eye disorders
Ocular Redness
|
11.9%
7/59
|
1.6%
1/62
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
- Publication restrictions are in place
Restriction type: OTHER