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:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01110499
First received: April 23, 2010
Last updated: May 25, 2012
Last verified: May 2012

April 23, 2010
May 25, 2012
August 2010
May 2011   (final data collection date for primary outcome measure)
Intraocular Pressure [ Time Frame: Part 1: Day 1,2,3,4,5,6,7, Part 2: Day 3, 8, 15, 22, 29 ] [ Designated as safety issue: No ]
Same as current
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
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Ocular Hypertension
  • Primary Open-Angle Glaucoma
  • Drug: Part 1: AGN-210961 Formulation 1 and bimatoprost ophthalmic solution 0.03%
    Part 1: One daily dose of AGN-210961 Formulation 1 in study eye and bimatoprost ophthalmic solution 0.03% in fellow eye for 7 consecutive days
    Other Name: LUMIGAN®
  • Drug: Part 1: AGN-210961 Formulation 2 and bimatoprost ophthalmic solution 0.03%
    Part 1: One daily dose of AGN-210961 Formulation 2 in study eye and bimatoprost ophthalmic solution 0.03% in fellow eye for 7 consecutive days
    Other Name: LUMIGAN®
  • Drug: Part 1: AGN-210961 Formulation 3 and bimatoprost ophthalmic solution 0.03%
    Part 1: One daily dose of AGN-210961 Formulation 3 in study eye and bimatoprost ophthalmic solution 0.03% in fellow eye for 7 consecutive days
    Other Name: LUMIGAN®
  • Drug: Part 1: AGN-210961 Formulation 4 and bimatoprost ophthalmic solution 0.03%
    Part 1: One daily dose of AGN-210961 Formulation 4 in study eye and bimatoprost ophthalmic solution 0.03% in fellow eye for 7 consecutive days
    Other Name: LUMIGAN®
  • Drug: Part 1: AGN-210961 Formulation 5 and bimatoprost ophthalmic solution 0.03%
    Part 1: One daily dose of AGN-210961 Formulation 5 in study eye and bimatoprost ophthalmic solution 0.03% in fellow eye for 7 consecutive days
    Other Name: LUMIGAN®
  • Drug: Part 1: AGN-210961 Formulation 6 and bimatoprost ophthalmic solution 0.03%
    Part 1: One daily dose of AGN-210961 Formulation 6 in study eye and bimatoprost ophthalmic solution 0.03% in fellow eye for 7 consecutive days
    Other Name: LUMIGAN®
  • Drug: Part 2: AGN-210961 Formulation to be selected from part 1
    Part 2: One daily dose of AGN-210961 Formulation to be selected from part 1 in both eyes for 28 consecutive days
  • Drug: Part 2: bimatoprost ophthalmic solution 0.03%
    Part 2: One daily dose of bimatoprost ophthalmic solution 0.03% in both eyes
    Other Name: LUMIGAN®
  • Experimental: Part 1, Arm 1
    AGN-210961 Formulation 1 and bimatoprost ophthalmic solution 0.03%
    Intervention: Drug: Part 1: AGN-210961 Formulation 1 and bimatoprost ophthalmic solution 0.03%
  • Experimental: Part 1, Arm 2
    AGN-210961 Formulation 2 and bimatoprost ophthalmic solution 0.03%
    Intervention: Drug: Part 1: AGN-210961 Formulation 2 and bimatoprost ophthalmic solution 0.03%
  • Experimental: Part 1, Arm 3
    AGN-210961 Formulation 3 and bimatoprost ophthalmic solution 0.03%
    Intervention: Drug: Part 1: AGN-210961 Formulation 3 and bimatoprost ophthalmic solution 0.03%
  • Experimental: Part 1, Arm 4
    AGN-210961 Formulation 4 and bimatoprost ophthalmic solution 0.03%
    Intervention: Drug: Part 1: AGN-210961 Formulation 4 and bimatoprost ophthalmic solution 0.03%
  • Experimental: Part 1, Arm 5
    AGN-210961 Formulation 5 and bimatoprost ophthalmic solution 0.03%
    Intervention: Drug: Part 1: AGN-210961 Formulation 5 and bimatoprost ophthalmic solution 0.03%
  • Experimental: Part 1, Arm 6
    AGN-210961 Formulation 6 and bimatoprost ophthalmic solution 0.03%
    Intervention: Drug: Part 1: AGN-210961 Formulation 6 and bimatoprost ophthalmic solution 0.03%
  • Experimental: Part 2, Arm 1
    AGN-210961 Formulation to be selected from part 1
    Intervention: Drug: Part 2: AGN-210961 Formulation to be selected from part 1
  • Active Comparator: Part 2, Arm 2
    bimatoprost ophthalmic solution 0.03%
    Intervention: Drug: Part 2: 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01110499
210961-002
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
May 2012

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