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Trial Outcomes & Findings for Safety and Efficacy Study of Bimatoprost, Latanoprost, and Travoprost in Patients With Elevated Intraocular Pressure (IOP) and Open-angle Glaucoma (OAG) (NCT NCT00716742)

NCT ID: NCT00716742

Last Updated: 2012-01-06

Results Overview

Change from baseline in bilateral (both eyes) IOP at the 1 year follow-up visit. IOP is a measure of the fluid pressure inside the eye. The bilateral IOP was calculated as an average between both eye's IOP. A negative number change from baseline indicates reduction in IOP (improvement).

Recruitment status

COMPLETED

Target enrollment

1099 participants

Primary outcome timeframe

Baseline, 1 Year

Results posted on

2012-01-06

Participant Flow

Participant milestones

Participant milestones
Measure
Lumigan®
bimatoprost 0.03%
Travatan®
travoprost 0.004%
Xalatan®
latanoprost 0.005%
Baseline
STARTED
364
370
365
Baseline
COMPLETED
347
356
352
Baseline
NOT COMPLETED
17
14
13
1 Year Follow-up
STARTED
347
356
352
1 Year Follow-up
COMPLETED
160
163
152
1 Year Follow-up
NOT COMPLETED
187
193
200
2 Year Follow-up
STARTED
160
163
152
2 Year Follow-up
COMPLETED
56
67
50
2 Year Follow-up
NOT COMPLETED
104
96
102
3 Year Follow-up
STARTED
56
67
50
3 Year Follow-up
COMPLETED
26
35
29
3 Year Follow-up
NOT COMPLETED
30
32
21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Study of Bimatoprost, Latanoprost, and Travoprost in Patients With Elevated Intraocular Pressure (IOP) and Open-angle Glaucoma (OAG)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Lumigan®
n=364 Participants
bimatoprost 0.03%
Travatan®
n=370 Participants
travoprost 0.004%
Xalatan®
n=365 Participants
latanoprost 0.005%
Total
n=1099 Participants
Total of all reporting groups
Age Continuous
65.5 years
n=5 Participants
67.0 years
n=7 Participants
67.0 years
n=5 Participants
67.0 years
n=4 Participants
Sex: Female, Male
Female
210 Participants
n=5 Participants
206 Participants
n=7 Participants
201 Participants
n=5 Participants
617 Participants
n=4 Participants
Sex: Female, Male
Male
154 Participants
n=5 Participants
164 Participants
n=7 Participants
164 Participants
n=5 Participants
482 Participants
n=4 Participants

PRIMARY outcome

Timeframe: Baseline, 1 Year

Population: Intent-to-treat, which includes all patients who started the study and completed the one-year follow-up visit and whose data was available for this outcome measure.

Change from baseline in bilateral (both eyes) IOP at the 1 year follow-up visit. IOP is a measure of the fluid pressure inside the eye. The bilateral IOP was calculated as an average between both eye's IOP. A negative number change from baseline indicates reduction in IOP (improvement).

Outcome measures

Outcome measures
Measure
Lumigan®
n=160 Participants
bimatoprost 0.03%
Travatan®
n=162 Participants
travoprost 0.004%
Xalatan®
n=152 Participants
latanoprost 0.005%
Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year
Baseline
20.8 Millimeters of mercury (mmHg)
Standard Deviation 5.2
20.3 Millimeters of mercury (mmHg)
Standard Deviation 5.0
20.6 Millimeters of mercury (mmHg)
Standard Deviation 5.2
Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year
Change from Baseline at 1 Year
-4.8 Millimeters of mercury (mmHg)
Standard Deviation 3.3
-4.3 Millimeters of mercury (mmHg)
Standard Deviation 2.7
-4.3 Millimeters of mercury (mmHg)
Standard Deviation 2.9

Adverse Events

Lumigan®

Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths

Travatan®

Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths

Xalatan®

Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Lumigan®
n=364 participants at risk
bimatoprost 0.03%
Travatan®
n=370 participants at risk
travoprost 0.004%
Xalatan®
n=365 participants at risk
latanoprost 0.005%
General disorders
Death
1.4%
5/364
0.54%
2/370
1.6%
6/365

Other adverse events

Adverse event data not reported

Additional Information

Vice President, Global Health Outcomes Strategy and Research

Allergan, Inc.

Phone: 714-246-4500

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