Open Angle Glaucoma, Ocular Hypertension
Conditions
Brief summary
This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin analogues
Interventions
bimatoprost 0.03%, 1 drop nightly for 3 months
travoprost 0.004% eye drops, 1 drop nightly for 3 months
latanoprost 0.005%, 1 drop nightly for 3 months
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of open-angle glaucoma (pseudoexfoliative or pigmentary glaucomas are allowed) or ocular hypertension
Exclusion criteria
* Known contraindication to latanoprost, bimatoprost or travoprost * Uncontrolled systemic disease * Active ocular disease other than glaucoma or ocular hypertension * Pregnant or lactating women or women of childbearing potential NOT utilizing a medically acceptable form of birth control
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3 | Baseline, Month 3 | Change from baseline in mean conjunctival hyperemia scores at month 3. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded using a 5-point scale in which 0=no redness and +3=deep, diffuse redness. A negative number change from baseline indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Corneal Staining With Fluorescein at Month 3 | Baseline, Month 3 | Change from baseline in corneal staining with fluorescein at month 3. The cornea is the transparent front part of the eye which covers the iris and pupil. To detect the presence or absence of corneal puncta (tiny disruptions in the surface of the eye), fluorescein dye is administered into the eye and the eye is graded using a 5-point scale where 0 equals no puncta (best), and 3 equals too many puncta to count (worst). A negative number change from baseline indicates improvement. |
| Change From Baseline in Tear Break-Up Time (TBUT) at Month 3 | Baseline, Month 3 | Change from baseline in TBUT at month 3. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost 0.03% bimatoprost 0.03% | 35 |
| Travoprost 0.004% travoprost 0.004% | 33 |
| Latanoprost 0.005% latanoprost 0.005% | 38 |
| Total | 106 |
Baseline characteristics
| Characteristic | Bimatoprost 0.03% | Travoprost 0.004% | Latanoprost 0.005% | Total |
|---|---|---|---|---|
| Age, Continuous | 69.3 years | 65.4 years | 67.3 years | 67.3 years |
| Sex: Female, Male Female | 22 Participants | 20 Participants | 19 Participants | 61 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 19 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 35 | 2 / 33 | 0 / 38 |
| serious Total, serious adverse events | 0 / 35 | 0 / 33 | 0 / 38 |
Outcome results
Primary
Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3
Change from baseline in mean conjunctival hyperemia scores at month 3. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded using a 5-point scale in which 0=no redness and +3=deep, diffuse redness. A negative number change from baseline indicates improvement.
Time frame: Baseline, Month 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost 0.03% | Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3 | Baseline | 0.74 Scores on Scale | Standard Error 0.1 |
| Bimatoprost 0.03% | Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3 | Month 3 | 0.05 Scores on Scale | Standard Error 0.1 |
| Travoprost 0.004% | Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3 | Baseline | 0.86 Scores on Scale | Standard Error 0.12 |
| Travoprost 0.004% | Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3 | Month 3 | 0.07 Scores on Scale | Standard Error 0.13 |
| Latanoprost 0.005% | Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3 | Baseline | 0.74 Scores on Scale | Standard Error 0.11 |
| Latanoprost 0.005% | Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3 | Month 3 | 0.06 Scores on Scale | Standard Error 0.1 |
Secondary
Change From Baseline in Corneal Staining With Fluorescein at Month 3
Change from baseline in corneal staining with fluorescein at month 3. The cornea is the transparent front part of the eye which covers the iris and pupil. To detect the presence or absence of corneal puncta (tiny disruptions in the surface of the eye), fluorescein dye is administered into the eye and the eye is graded using a 5-point scale where 0 equals no puncta (best), and 3 equals too many puncta to count (worst). A negative number change from baseline indicates improvement.
Time frame: Baseline, Month 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost 0.03% | Change From Baseline in Corneal Staining With Fluorescein at Month 3 | Baseline | 0.59 Scores on a Scale | Standard Error 0.12 |
| Bimatoprost 0.03% | Change From Baseline in Corneal Staining With Fluorescein at Month 3 | Month 3 | 0.15 Scores on a Scale | Standard Error 0.15 |
| Travoprost 0.004% | Change From Baseline in Corneal Staining With Fluorescein at Month 3 | Baseline | 0.48 Scores on a Scale | Standard Error 0.11 |
| Travoprost 0.004% | Change From Baseline in Corneal Staining With Fluorescein at Month 3 | Month 3 | -0.07 Scores on a Scale | Standard Error 0.12 |
| Latanoprost 0.005% | Change From Baseline in Corneal Staining With Fluorescein at Month 3 | Baseline | 0.70 Scores on a Scale | Standard Error 0.13 |
| Latanoprost 0.005% | Change From Baseline in Corneal Staining With Fluorescein at Month 3 | Month 3 | -0.18 Scores on a Scale | Standard Error 0.11 |
Secondary
Change From Baseline in Tear Break-Up Time (TBUT) at Month 3
Change from baseline in TBUT at month 3. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement.
Time frame: Baseline, Month 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost 0.03% | Change From Baseline in Tear Break-Up Time (TBUT) at Month 3 | Baseline | 9.1 Seconds | Standard Error 1 |
| Bimatoprost 0.03% | Change From Baseline in Tear Break-Up Time (TBUT) at Month 3 | Month 3 | 0.5 Seconds | Standard Error 0.9 |
| Travoprost 0.004% | Change From Baseline in Tear Break-Up Time (TBUT) at Month 3 | Baseline | 7.9 Seconds | Standard Error 0.8 |
| Travoprost 0.004% | Change From Baseline in Tear Break-Up Time (TBUT) at Month 3 | Month 3 | 1.7 Seconds | Standard Error 0.8 |
| Latanoprost 0.005% | Change From Baseline in Tear Break-Up Time (TBUT) at Month 3 | Baseline | 8.6 Seconds | Standard Error 0.8 |
| Latanoprost 0.005% | Change From Baseline in Tear Break-Up Time (TBUT) at Month 3 | Month 3 | 0.4 Seconds | Standard Error 1 |