A Phase 4 interventional study of travoprost ophthalmic solution 0.004% and travoprost 0.004% / timolol 0.5% combination ophthalmic solution in Glaucoma, Open-Angle and Ocular Hypertension, sponsored by Allergan. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-15.
Sponsored by Allergan · Phase 4, Interventional, and Treatment
This non-inferiority study will assess safety and efficacy of LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) versus DuoTrav® (travoprost 0.004%/timolol 0.5% combination ophthalmic solution) in patients previously on Travatan® Z (travoprost ophthalmic solution 0.004%) monotherapy.
649 studies on the registry are indexed under Ocular Hypertension; 48 are open to participants now.
This study's enrollment of 135 is above the median of 120 across 510 interventional studies indexed under Ocular Hypertension.
Browse Ocular Hypertension 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.
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Exclusion Criteria:
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
Drug: travoprost ophthalmic solution 0.004% · Drug: Bimatoprost ophthalmic solution 0.01%
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
Drug: travoprost ophthalmic solution 0.004% · Drug: travoprost 0.004% / timolol 0.5% combination ophthalmic solution
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks.
Also known as: Travatan® Z
DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
Also known as: DuoTrav®
LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
Also known as: LUMIGAN® RC
Mean Diurnal Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each study eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
Time frame: Week 12
Change From Baseline in Mean IOP at Week 12
IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 12. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.
Time frame: Baseline, Week 12
Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline
IOP is a measurement of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
Time frame: Baseline, Week 12
Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg
IOP is a measure of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
Time frame: Week 12
Change From Baseline in Mean IOP at Week 6
IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 6. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.
Time frame: Baseline, Week 6
| Milestone | LUMIGAN® RC | DuoTrav® |
|---|---|---|
| Started | 67 | 68 |
| Completed | 61 | 63 |
| Not completed | 6 | 5 |
| Withdrew: Withdrew consent | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Protocol violation | 1 | 1 |
| Withdrew: Other miscellaneous reasons | 2 | 1 |
IOP is a measurement of the fluid pressure inside the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each study eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
| mmHg | LUMIGAN® RC | DuoTrav® |
|---|---|---|
| Mean Diurnal Intraocular Pressure (IOP) | 18.6 ± 3.5 | 17.4 ± 2.7 |
IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 12. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.
| mmHg | LUMIGAN® RC | DuoTrav® |
|---|---|---|
| Baseline_8 AM | 22.0 ± 2.9 | 22.0 ± 4.1 |
| Change from Baseline at Week 12 _8 AM (n=61,63) | -2.7 ± 3.4 | -4.5 ± 3.1 |
| Baseline_12 Noon | 20.6 ± 3.2 | 20.3 ± 3.8 |
| Change from Baseline at Week 12_12 Noon (n=61,63) | -1.9 ± 3.1 | -2.3 ± 3.2 |
| Baseline_4 PM | 19.8 ± 3.1 | 19.8 ± 4.1 |
| Change from Baseline at Week 12_4 PM (n=61,63) | -1.3 ± 2.7 | -2.4 ± 3.5 |
IOP is a measurement of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
| percentage of participants | LUMIGAN® RC | DuoTrav® |
|---|---|---|
| Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline | 26.2 | 47.6 |
IOP is a measure of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
| percentage of participants | LUMIGAN® RC | DuoTrav® |
|---|---|---|
| Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg | 11.5 | 17.5 |
IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 6. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.
| mmHg | LUMIGAN® RC | DuoTrav® |
|---|---|---|
| Baseline_ 8 AM | 22.0 ± 2.9 | 22.0 ± 4.1 |
| Change from Baseline at Week 6 _8 AM (n=66,64) | -2.8 ± 2.9 | -4.8 ± 4.1 |
| Baseline_12 Noon | 20.6 ± 3.2 | 20.3 ± 3.8 |
| Change from Baseline at Week 6_12 Noon (n=66,64) | -2.1 ± 3.1 | -2.8 ± 3.4 |
| Baseline_4 PM | 19.8 ± 3.1 | 19.8 ± 4.1 |
| Change from Baseline at Week 6_4 PM (n=66,64) | -1.5 ± 2.5 | -2.9 ± 3.6 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Travatan® Z | — | 0/135 (0%) | 0/135 (0%) |
| LUMIGAN® RC | — | 0/67 (0%) | 0/67 (0%) |
| DuoTrav® | — | 1/68 (1.5%) | 0/68 (0%) |
| Event | Travatan® Z | LUMIGAN® RC | DuoTrav® |
|---|---|---|---|
| PyrexiaGeneral disorders | 0/135 | 0/67 | 1/68 |
| CellulitisInfections and infestations | 0/135 | 0/67 | 1/68 |
| Age, Continuous(Years) | LUMIGAN® RC | DuoTrav® | Total |
|---|---|---|---|
| Mean | 67.2 ± 9.7 | 65.2 ± 10.7 | 66.2 ± 10.3 |
| Sex: Female, Male(Participants) | LUMIGAN® RC | DuoTrav® | Total |
|---|---|---|---|
| Female | 40 | 40 | 80 |
| Male | 27 | 28 | 55 |
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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