Open-angle Glaucoma (OAG), Ocular Hypertension
Conditions
Brief summary
The purpose of this study is to determine the safety and efficacy of three concentrations of travoprost ophthalmic solution (Groups A, B and C) administered eight times daily.
Interventions
1 drop in each eye once daily for five days, and 1 drop vehicle in each eye 7 times daily for 5 days
1 drop in each eye 8 times daily for 5 days
DRUGTravoprost (Groups A, B and C)
1 drop in each eye 8 times daily for 5 days
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. either sex and any race/ethnicity, ≥18 years old 2. diagnosed with open-angle glaucoma, and/or ocular hypertension 3. meets the following IOP entry criteria: * Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1 * Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1 4. satisfies all informed consent requirements; able to read, sign and date the informed consent
Exclusion criteria
1. females of childbearing potential not meeting protocol conditions 2. angle grade less than Grade 2 in either eye 3. cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye 4. severe central visual field loss in either eye 5. any abnormality preventing reliable applanation tonometry in either eye 6. hypersensitivity to prostaglandin analogues or to any component of the study medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5 | 5 days | Outcome measure shows how each treatment reduced eye pressure at 8 AM on Day 5 compared to the eye pressure at 8 AM before the start of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IOP Change From Baseline at 8 PM on Day 5 | 5 Days | Outcome measure shows how each treatment reducted eye pressure at 8 PM on Day 5 compared to the eye pressure at 8 PM before the start of treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TRAVATAN TRAVATAN 0.004% once daily | 14 |
| Travoprost Vehicle Travoprost Vehicle | 14 |
| Travoprost Group A Travoprost Group A | 14 |
| Travoprost Group B Travoprost Group B | 13 |
| Travoprost Group C Travoprost Group C | 12 |
| Total | 67 |
Baseline characteristics
| Characteristic | TRAVATAN | Travoprost Vehicle | Travoprost Group A | Travoprost Group B | Travoprost Group C | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 6 Participants | 5 Participants | 9 Participants | 9 Participants | 35 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 8 Participants | 9 Participants | 4 Participants | 3 Participants | 32 Participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 6 Participants | 9 Participants | 8 Participants | 37 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 8 Participants | 4 Participants | 4 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 14 | 2 / 14 | 5 / 14 | 8 / 13 | 6 / 12 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 13 | 0 / 12 |
Outcome results
Primary
Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5
Outcome measure shows how each treatment reduced eye pressure at 8 AM on Day 5 compared to the eye pressure at 8 AM before the start of treatment
Time frame: 5 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Travatan 0.004% QD | Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5 | -9.8 mm Hg |
| Travoprost Vehicle | Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5 | -2.9 mm Hg |
| Travoprost Group A | Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5 | -5.0 mm Hg |
| Travoprost Group B | Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5 | -6.5 mm Hg |
| Travoprost Group C | Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5 | -6.8 mm Hg |
Secondary
IOP Change From Baseline at 8 PM on Day 5
Outcome measure shows how each treatment reducted eye pressure at 8 PM on Day 5 compared to the eye pressure at 8 PM before the start of treatment
Time frame: 5 Days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Travatan 0.004% QD | IOP Change From Baseline at 8 PM on Day 5 | -3.9 mm Hg |
| Travoprost Vehicle | IOP Change From Baseline at 8 PM on Day 5 | -0.9 mm Hg |
| Travoprost Group A | IOP Change From Baseline at 8 PM on Day 5 | -2.7 mm Hg |
| Travoprost Group B | IOP Change From Baseline at 8 PM on Day 5 | -5.7 mm Hg |
| Travoprost Group C | IOP Change From Baseline at 8 PM on Day 5 | -4.8 mm Hg |