A Phase 4 interventional study of Travoprost 0.004% (Travatan) and Pilocarpine 1% in Angle-closure Glaucoma, sponsored by Alcon Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-06.
Sponsored by Alcon Research (part of Alcon) · Phase 4, Interventional, and Treatment
The purpose of this study is to demonstrate that the Intraocular Pressure (IOP) lowering efficacy of Travoprost Ophthalmic Solution 0.004% is superior to that of Pilocarpine 1% in patients with chronic angle-closure glaucoma (CACG).
91 studies on the registry are indexed under Glaucoma, Angle-Closure; 17 are open to participants now.
This study's enrollment of 30 is below the median of 57 across 58 interventional studies indexed under Glaucoma, Angle-Closure.
Browse Glaucoma, Angle-Closure studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.
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Exclusion Criteria:
One drop in each eye, once daily at 9 AM
Drug: Travoprost 0.004% (Travatan)
One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks
Drug: Pilocarpine 1%
One drop in each eye, once daily at 9 AM
One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks
Mean Intraocular Pressure (IOP)
Time frame: 4PM at Week 12 Visit
Number of Patients With Peripheral Anterior Synechiae (PAS)
Time frame: Week 12 Visit
30 patients were enrolled in this study
| Milestone | Travoprost 0.004% (Travatan) | Pilocarpine 1% |
|---|---|---|
| Started | 16 | 14 |
| Completed | 12 | 12 |
| Not completed | 4 | 2 |
| millimeters mercury (mm Hg) | Travoprost 0.004% (Travatan) | Pilocarpine 1% |
|---|---|---|
| Mean Intraocular Pressure (IOP) | 15.77 ± 2.32 | 18.35 ± 3.72 |
| Participants | Travoprost 0.004% (Travatan) | Pilocarpine 1% |
|---|---|---|
| Number of Patients With Peripheral Anterior Synechiae (PAS) | 0 | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Travoprost 0.004% (Travatan) | — | 0/16 (0%) | 0/16 (0%) |
| Pilocarpine 1% | — | 0/14 (0%) | 0/14 (0%) |
| Age, Categorical(Participants) | Travoprost 0.004% (Travatan) | Pilocarpine 1% | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 3 | 5 |
| >=65 years | 14 | 11 | 25 |
| Sex: Female, Male(Participants) | Travoprost 0.004% (Travatan) | Pilocarpine 1% | Total |
|---|---|---|---|
| Female | 9 | 6 | 15 |
| Male | 7 | 8 | 15 |
No study locations are listed for this record.
The record gives a start of Feb 2007, a primary completion of May 2008 and a completion of May 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2010, 1 year 10 months after primary completion.
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This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Travoprost