Ocular Hypertension, Open-Angle Glaucoma
Conditions
Keywords
Comfort
Brief summary
The purpose of this study is to compare the comfort of Travatan Z in one eye and Xalatan in the opposite eye in patients with primary open-angle glaucoma or ocular hypertension.
Interventions
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as travoprost.
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as latanoprost.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older. * Clinical diagnosis of ocular hypertension, primary open-angle, pigment dispersion, or exfoliation glaucoma in both eyes. * Best corrected visual acuity of 20/200 Snellen or better in each eye. * Intraocular pressure within protocol-specified range. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Any abnormality preventing reliable applanation tonometry in the study eye(s). * Any eye conditions or procedures as specified in protocol. * Progressive retinal or optic nerve disease from any cause. * Use of contact lenses in the study eye(s). * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort Immediately After Dosing | 5 seconds | Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable. |
Participant flow
Recruitment details
Patients were recruited from two US glaucoma specialty clinics from 6/8/2007 to 8/13/2008. Eligible patients having a diagnosis of open-angle glaucoma or ocular hypertension in both eyes were enrolled.
Pre-assignment details
54 patients were enrolled in the study. Qualified patients ceased prostaglandin use for 3-5 days (wash-out) prior to Visit 2 (randomization).
Participants by arm
| Arm | Count |
|---|---|
| Travoprost/Latanoprost Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control. | 54 |
| Total | 54 |
Baseline characteristics
| Characteristic | Travoprost/Latanoprost |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 24 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 54 | 0 / 54 |
| serious Total, serious adverse events | 0 / 54 | 0 / 54 |
Outcome results
Primary
Comfort Immediately After Dosing
Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable.
Time frame: 5 seconds
Population: Intent to treat: All patients who received test article and completed the trial.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Travoprost | Comfort Immediately After Dosing | 7.8 Units on a scale | Standard Deviation 16.1 |
| Latanoprost | Comfort Immediately After Dosing | 7.1 Units on a scale | Standard Deviation 16.2 |