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Safety and Efficacy of LUMIGAN® RC Versus DuoTrav® in Patients Who Require Further Intraocular Pressure (IOP) Reduction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01547598
First received: February 10, 2012
Last updated: July 28, 2014
Last verified: July 2014

February 10, 2012
July 28, 2014
December 2011
July 2013   (final data collection date for primary outcome measure)
Mean Diurnal Intraocular Pressure (IOP) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
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.
Diurnal Intraocular Pressure (IOP) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01547598 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Mean IOP at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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 With Mean Diurnal IOP Less Than 18 mmHg [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Mean IOP at Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    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.
  • Change from Baseline in IOP [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Patients with ≥15% Reduction in IOP from Baseline [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Patients With Diurnal IOP Less Than 18 mmHg [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in IOP [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of LUMIGAN® RC Versus DuoTrav® in Patients Who Require Further Intraocular Pressure (IOP) Reduction
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Glaucoma, Open-Angle
  • Ocular Hypertension
  • Drug: travoprost ophthalmic solution 0.004%
    Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks.
    Other Name: Travatan® Z
  • Drug: travoprost 0.004% / timolol 0.5% combination ophthalmic solution
    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.
    Other Name: DuoTrav®
  • Drug: Bimatoprost ophthalmic solution 0.01%
    LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
    Other Name: LUMIGAN® RC
  • Active Comparator: LUMIGAN® RC
    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.
    Interventions:
    • Drug: travoprost ophthalmic solution 0.004%
    • Drug: Bimatoprost ophthalmic solution 0.01%
  • Active Comparator: DuoTrav®
    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.
    Interventions:
    • Drug: travoprost ophthalmic solution 0.004%
    • Drug: travoprost 0.004% / timolol 0.5% combination ophthalmic solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
135
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Open angle glaucoma or ocular hypertension
  • Best corrected visual acuity of 20/100 or better in both eyes

Exclusion Criteria:

  • Ocular surgery within 3 months, or anticipated ocular surgery within 12 weeks
  • Previous treatment with LUMIGAN® RC or DuoTrav®
  • History of LASIK, LASEK, RK or PRK in the study eye(s)
  • Active ocular inflammation
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01547598
GMA-LUM-11-020
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP