Trial Outcomes & Findings for Travoprost 0.004% Versus Pilocarpine 1% in Patients With Chronic Angle Closure Glaucoma (CACG) (NCT NCT00762645)
NCT ID: NCT00762645
Last Updated: 2023-12-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
4PM at Week 12 Visit
Results posted on
2023-12-06
Participant Flow
30 patients were enrolled in this study
Patients randomized at 1:1 ratio into two treatment groups
Participant milestones
| Measure |
Travoprost 0.004% (Travatan)
Travoprost 0.004% Ophthalmic Solution
|
Pilocarpine 1%
Pilocarpine 1% Ophthalmic Solution
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Travoprost 0.004% Versus Pilocarpine 1% in Patients With Chronic Angle Closure Glaucoma (CACG)
Baseline characteristics by cohort
| Measure |
Travoprost 0.004% (Travatan)
n=16 Participants
Travoprost 0.004% Ophthalmic Solution
|
Pilocarpine 1%
n=14 Participants
Pilocarpine 1% Ophthalmic Solution
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4PM at Week 12 VisitOutcome measures
| Measure |
Travoprost 0.004% (Travatan)
n=16 Participants
Travoprost 0.004% Ophthalmic Solution
|
Pilocarpine 1%
n=14 Participants
Pilocarpine 1% Ophthalmic Solution
|
|---|---|---|
|
Mean Intraocular Pressure (IOP)
|
15.77 millimeters mercury (mm Hg)
Standard Deviation 2.32
|
18.35 millimeters mercury (mm Hg)
Standard Deviation 3.72
|
SECONDARY outcome
Timeframe: Week 12 VisitOutcome measures
| Measure |
Travoprost 0.004% (Travatan)
n=16 Participants
Travoprost 0.004% Ophthalmic Solution
|
Pilocarpine 1%
n=14 Participants
Pilocarpine 1% Ophthalmic Solution
|
|---|---|---|
|
Number of Patients With Peripheral Anterior Synechiae (PAS)
|
0 Participants
|
0 Participants
|
Adverse Events
Travoprost 0.004% (Travatan)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pilocarpine 1%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place