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OpenTrials
Completed

NCT Number: NCT01110499

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

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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Key information

Conditions

Ocular Hypertension Eye Diseases Glaucoma Glaucoma, Open-Angle Primary Open-Angle Glaucoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Newport Beach, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AGN-210961 Formulation 1

Drug

AGN-210961 Formulation 1 in one eye once daily for 7 days.

AGN-210961 Formulation 2

Drug

AGN-210961 Formulation 2 in one eye once daily for 7 days.

AGN-210961 Formulation 3

Drug

AGN-210961 Formulation 3 in one eye once daily for 7 days.

AGN-210961 Formulation 4

Drug

AGN-210961 Formulation 4 in one eye once daily for 7 days.

AGN-210961 Formulation 5

Drug

AGN-210961 Formulation 5 in one eye once daily for 7 days.

AGN-210961 Formulation 6

Drug

AGN-210961 Formulation 6 in one eye once daily for 7 days.

AGN-210961 Formulation 7

Drug

AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.

bimatoprost ophthalmic solution 0.03%

Drug

bimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks.

Other names: LUMIGAN®

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 26, 2010
Registry last updated
Aug 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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