Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
This study evaluated the ocular surface tolerability of the prostaglandin analogues bimatoprost ophthalmic solution 0.01% (Lumigan® 0.01%), travoprost ophthalmic solution 0.004% (Travatan Z®) and latanoprost ophthalmic solution 0.005% (Xalatan®) in patients previously treated with Xalatan® who have open-angle glaucoma or ocular hypertension.
Interventions
One drop of bimatoprost ophthalmic solution 0.01% administered to affected eye(s), once daily in the evening for 12 weeks.
One drop of travoprost ophthalmic solution 0.004% administered to affected eye(s), once daily in the evening for 12 weeks.
One drop of latanoprost ophthalmic solution 0.005% administered to affected eye(s), once daily in the evening for 12 weeks.
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 ocular hypertension or open-angle glaucoma in at least 1 eye requiring treatment with an anti-glaucoma/ocular hypertensive medication * Best corrected visual acuity score of 20/100 or better in both eyes * Females on birth control pills must be on same type of pill and dose for at least 3 month
Exclusion criteria
* Use of Lumigan® 0.01%/Lumigan® RC, Lumigan®, Travatan® or Travatan Z® within 6 months * History of or active ocular infection/inflammation (eg, uveitis) * Punctal plug use * Required use of ocular medications during the study other than study medication (intermittent use of certain types artificial tears acceptable) * Intraocular surgery or glaucoma laser surgery in study eye(s) within 3 months * History of corneal refractive laser surgery (eg, LASIK, LASEK) in study eye(s) * Planned contact lens wear during study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Conjunctival Hyperemia at Week 12 | Week 12 | Conjunctival hyperemia was analyzed using the average of the scores of both eyes. 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 on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Corneal Staining With Fluorescein at Week 12 | Week 12 | Corneal staining was analyzed using the average of the scores of both eyes. 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=None (no puncta), 0.5=Trace (1-5 puncta), 1=Mild (6-20 puncta), 2=Moderate (\>20 puncta) and 3=Severe (too many puncta to count). |
| Mean Tear Break Up Time (TBUT) at Week 12 | Week 12 | Tear Break Up Time was analyzed using the average of the readings of both eyes. 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost Ophthalmic Solution 0.01% One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks. | 56 |
| Travoprost Ophthalmic Solution 0.004% One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks. | 53 |
| Latanoprost Ophthalmic Solution 0.005% One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks. | 55 |
| Total | 164 |
Baseline characteristics
| Characteristic | Bimatoprost Ophthalmic Solution 0.01% | Travoprost Ophthalmic Solution 0.004% | Latanoprost Ophthalmic Solution 0.005% | Total |
|---|---|---|---|---|
| Age Continuous | 65.1 Years STANDARD_DEVIATION 11.76 | 63.2 Years STANDARD_DEVIATION 13.57 | 64.7 Years STANDARD_DEVIATION 12.28 | 64.3 Years STANDARD_DEVIATION 12.49 |
| Sex: Female, Male Female | 36 Participants | 25 Participants | 31 Participants | 92 Participants |
| Sex: Female, Male Male | 20 Participants | 28 Participants | 24 Participants | 72 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 | 0 / 56 | 0 / 53 | 0 / 55 |
| serious Total, serious adverse events | 1 / 56 | 1 / 53 | 3 / 55 |
Outcome results
Primary
Mean Conjunctival Hyperemia at Week 12
Conjunctival hyperemia was analyzed using the average of the scores of both eyes. 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 on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness).
Time frame: Week 12
Population: Intent-to-treat population (ITT) included all participants who were randomized to study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bimatoprost Ophthalmic Solution 0.01% | Mean Conjunctival Hyperemia at Week 12 | 0.42 Score on a scale | Standard Deviation 0.48 |
| Travoprost Ophthalmic Solution 0.004% | Mean Conjunctival Hyperemia at Week 12 | 0.46 Score on a scale | Standard Deviation 0.44 |
| Latanoprost Ophthalmic Solution 0.005% | Mean Conjunctival Hyperemia at Week 12 | 0.44 Score on a scale | Standard Deviation 0.57 |
Secondary
Mean Corneal Staining With Fluorescein at Week 12
Corneal staining was analyzed using the average of the scores of both eyes. 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=None (no puncta), 0.5=Trace (1-5 puncta), 1=Mild (6-20 puncta), 2=Moderate (\>20 puncta) and 3=Severe (too many puncta to count).
Time frame: Week 12
Population: Intent-to-treat (ITT) population included all participants who were randomized and received study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bimatoprost Ophthalmic Solution 0.01% | Mean Corneal Staining With Fluorescein at Week 12 | 0.31 Score on a scale | Standard Deviation 0.45 |
| Travoprost Ophthalmic Solution 0.004% | Mean Corneal Staining With Fluorescein at Week 12 | 0.32 Score on a scale | Standard Deviation 0.48 |
| Latanoprost Ophthalmic Solution 0.005% | Mean Corneal Staining With Fluorescein at Week 12 | 0.22 Score on a scale | Standard Deviation 0.3 |
Secondary
Mean Tear Break Up Time (TBUT) at Week 12
Tear Break Up Time was analyzed using the average of the readings of both eyes. 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.
Time frame: Week 12
Population: Intent-to-treat (ITT) population included all participants who were randomized and received study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bimatoprost Ophthalmic Solution 0.01% | Mean Tear Break Up Time (TBUT) at Week 12 | 9.7 Seconds | Standard Deviation 5.71 |
| Travoprost Ophthalmic Solution 0.004% | Mean Tear Break Up Time (TBUT) at Week 12 | 9.7 Seconds | Standard Deviation 4.96 |
| Latanoprost Ophthalmic Solution 0.005% | Mean Tear Break Up Time (TBUT) at Week 12 | 9.3 Seconds | Standard Deviation 4.04 |