A Phase 4 interventional study of Bimatoprost 0.03% and travoprost 0.004% in Open Angle Glaucoma and Ocular Hypertension, sponsored by Allergan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-24.
Sponsored by Allergan · Phase 4, Interventional, and Treatment
This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin analogues
929 studies on the registry are indexed under Glaucoma, Open-Angle; 122 are open to participants now.
This study's enrollment of 106 is above the median of 80 across 700 interventional studies indexed under Glaucoma, Open-Angle.
Browse Glaucoma, Open-Angle studies →Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
bimatoprost 0.03%
Drug: Bimatoprost 0.03%
travoprost 0.004%
Drug: travoprost 0.004%
latanoprost 0.005%
Drug: latanoprost 0.005% eye drops
bimatoprost 0.03%, 1 drop nightly for 3 months
Also known as: Lumigan®
travoprost 0.004% eye drops, 1 drop nightly for 3 months
Also known as: Travatan® Z
latanoprost 0.005%, 1 drop nightly for 3 months
Also known as: Xalatan®
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
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
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
| Milestone | Bimatoprost 0.03% | Travoprost 0.004% | Latanoprost 0.005% |
|---|---|---|---|
| Started | 35 | 33 | 38 |
| Completed | 32 | 31 | 36 |
| Not completed | 3 | 2 | 2 |
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.
| Scores on Scale | Bimatoprost 0.03% | Travoprost 0.004% | Latanoprost 0.005% |
|---|---|---|---|
| Baseline | 0.74 ± 0.10 | 0.86 ± 0.12 | 0.74 ± 0.11 |
| Month 3 | 0.05 ± 0.1 | 0.07 ± 0.13 | 0.06 ± 0.10 |
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.
| Scores on a Scale | Bimatoprost 0.03% | Travoprost 0.004% | Latanoprost 0.005% |
|---|---|---|---|
| Baseline | 0.59 ± 0.12 | 0.48 ± 0.11 | 0.70 ± 0.13 |
| Month 3 | 0.15 ± 0.15 | -0.07 ± 0.12 | -0.18 ± 0.11 |
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.
| Seconds | Bimatoprost 0.03% | Travoprost 0.004% | Latanoprost 0.005% |
|---|---|---|---|
| Baseline | 9.1 ± 1.0 | 7.9 ± 0.8 | 8.6 ± 0.8 |
| Month 3 | 0.5 ± 0.9 | 1.7 ± 0.8 | 0.4 ± 1.0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bimatoprost 0.03% | — | 0/35 (0%) | 1/35 (2.9%) |
| Travoprost 0.004% | — | 0/33 (0%) | 2/33 (6.1%) |
| Latanoprost 0.005% | — | 0/38 (0%) | 0/38 (0%) |
| Event | Bimatoprost 0.03% | Travoprost 0.004% | Latanoprost 0.005% |
|---|---|---|---|
| HeadacheNervous system disorders | 1/35 | 2/33 | 0/38 |
| Age, Continuous(years) | Bimatoprost 0.03% | Travoprost 0.004% | Latanoprost 0.005% | Total |
|---|---|---|---|---|
| Mean | 69.3 (57 to 81) | 65.4 (52 to 78) | 67.3 (57 to 77) | 67.3 (52 to 81) |
| Sex: Female, Male(Participants) | Bimatoprost 0.03% | Travoprost 0.004% | Latanoprost 0.005% | Total |
|---|---|---|---|---|
| Female | 22 | 20 | 19 | 61 |
| Male | 13 | 13 | 19 | 45 |
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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