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Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01110499
First Posted: April 26, 2010
Last Update Posted: August 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
April 23, 2010
April 26, 2010
May 31, 2013
August 5, 2014
August 5, 2014
June 2010
May 2011   (Final data collection date for primary outcome measure)
  • Part 1: Change From Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, Day 7 ]
    IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups.
  • Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) [ Time Frame: Baseline, Day 29 ]
    IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12.
Intraocular Pressure [ Time Frame: Part 1: Day 1,2,3,4,5,6,7, Part 2: Day 3, 8, 15, 22, 29 ]
Complete list of historical versions of study NCT01110499 on ClinicalTrials.gov Archive Site
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Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
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This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost ophthalmic solution 0.03% for 4 weeks.
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Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Ocular Hypertension
  • Primary Open-Angle Glaucoma
  • Drug: AGN-210961 Formulation 1
    AGN-210961 Formulation 1 in one eye once daily for 7 days.
  • Drug: AGN-210961 Formulation 2
    AGN-210961 Formulation 2 in one eye once daily for 7 days.
  • Drug: AGN-210961 Formulation 3
    AGN-210961 Formulation 3 in one eye once daily for 7 days.
  • Drug: AGN-210961 Formulation 4
    AGN-210961 Formulation 4 in one eye once daily for 7 days.
  • Drug: AGN-210961 Formulation 5
    AGN-210961 Formulation 5 in one eye once daily for 7 days.
  • Drug: AGN-210961 Formulation 6
    AGN-210961 Formulation 6 in one eye once daily for 7 days.
  • Drug: AGN-210961 Formulation 7
    AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.
  • Drug: bimatoprost ophthalmic solution 0.03%
    bimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks.
    Other Name: LUMIGAN®
  • Experimental: Part 1, AGN-210961 Formulation 1
    AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
    Intervention: Drug: AGN-210961 Formulation 1
  • Experimental: Part 1, AGN-210961 Formulation 2
    AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
    Intervention: Drug: AGN-210961 Formulation 2
  • Experimental: Part 1, AGN-210961 Formulation 3
    AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
    Intervention: Drug: AGN-210961 Formulation 3
  • Experimental: Part 1, AGN-210961 Formulation 4
    AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
    Intervention: Drug: AGN-210961 Formulation 4
  • Experimental: Part 1, AGN-210961 Formulation 5
    AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
    Intervention: Drug: AGN-210961 Formulation 5
  • Experimental: Part 1, AGN-210961 Formulation 6
    AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
    Intervention: Drug: AGN-210961 Formulation 6
  • Experimental: Part 2, AGN-210961 Formulation 7
    AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.
    Intervention: Drug: AGN-210961 Formulation 7
  • Active Comparator: Part 2, bimatoprost ophthalmic solution 0.03%
    bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
    Intervention: Drug: bimatoprost ophthalmic solution 0.03%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
163
June 2011
May 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

- Ocular hypertension or primary open-angle glaucoma in each eye

Exclusion Criteria:

  • Any active ocular disease
  • Anticipated wearing of contact lenses during study
  • Anticipated use of artificial tears during study
  • Contraindication to pupil dilatation
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01110499
210961-002
No
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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