Angle-closure Glaucoma
Conditions
Keywords
IOP lowering efficacy, CACG
Brief summary
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).
Interventions
DRUGTravoprost 0.004% (Travatan)
One drop in each eye, once daily at 9 AM
DRUGPilocarpine 1%
One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Chronic Angle Closure Glaucoma (CACG) * 21-35 millimeters mercury mean intraocular pressure on Eligibility visit day at 9 AM * Peripheral iridotomy performed ≥ 1 Month prior to the Screening visit * Anterior chamber angle in which the trabecular meshwork is not visible for ≥180 degrees in gonioscopy without indentation * Peripheral anterior synechiae (PAS)
Exclusion criteria
* Traumatic damage of the anterior chamber angle * History of ocular inflammation or surgery (except for iridotomy) ≤ 3 months * Patients who cannot be safely discontinued from use of all ocular hypotensive medication(s) for 12 days to 14 weeks * Visual Acuity ≥ 1.0 * Contact lenses wearer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Intraocular Pressure (IOP) | 4PM at Week 12 Visit |
Secondary
| Measure | Time frame |
|---|---|
| Number of Patients With Peripheral Anterior Synechiae (PAS) | Week 12 Visit |
Participant flow
Recruitment details
30 patients were enrolled in this study
Pre-assignment details
Patients randomized at 1:1 ratio into two treatment groups
Participants by arm
| Arm | Count |
|---|---|
| Travoprost 0.004% (Travatan) Travoprost 0.004% Ophthalmic Solution | 16 |
| Pilocarpine 1% Pilocarpine 1% Ophthalmic Solution | 14 |
| Total | 30 |
Baseline characteristics
| Characteristic | Travoprost 0.004% (Travatan) | Pilocarpine 1% | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 11 Participants | 25 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Female | 9 Participants | 6 Participants | 15 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 14 |
| serious Total, serious adverse events | 0 / 16 | 0 / 14 |
Outcome results
Primary
Mean Intraocular Pressure (IOP)
Time frame: 4PM at Week 12 Visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Travoprost 0.004% (Travatan) | Mean Intraocular Pressure (IOP) | 15.77 millimeters mercury (mm Hg) | Standard Deviation 2.32 |
| Pilocarpine 1% | Mean Intraocular Pressure (IOP) | 18.35 millimeters mercury (mm Hg) | Standard Deviation 3.72 |
Secondary
Number of Patients With Peripheral Anterior Synechiae (PAS)
Time frame: Week 12 Visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Travoprost 0.004% (Travatan) | Number of Patients With Peripheral Anterior Synechiae (PAS) | 0 Participants |
| Pilocarpine 1% | Number of Patients With Peripheral Anterior Synechiae (PAS) | 0 Participants |