Skip to main content
OpenTrials
Completed

NCT Number: NCT00809848

Safety and Efficacy of AGN 210669 Ophthalmic Solution in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma

The study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution in comparison with AGN-210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each morning, in subjects with ocular hypertension or primary open-angle glaucoma. Subjects will be followed for 2 weeks.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ocular Hypertension Eye Diseases Glaucoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Artesia, 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
  • Females of non-childbearing potential
  • Subject requires IOP-lowering therapy in both eyes
  • IOP ≥ 22 mm Hg and ≤ 34 mm Hg
  • Has a visual acuity score of 20/100 or better in each eye

Exclusion criteria

  • Uncontrolled systemic disease
  • Active ocular disease
  • Alteration of existing chronic systemic medications
  • Known allergy or sensitivity to the study medications
  • Ophthalmic corticosteroids
  • Visual field loss which in the opinion of the investigator is functionally significant
  • History of ocular laser, intraocular surgery, or refractive surgery

Treatment and study plan

AGN-210669 ophthalmic solution, 0.075%

Drug

AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.

AGN-210669 ophthalmic solution, 0.05%

Drug

AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.

AGN-210669 ophthalmic solution, 0.025%

Drug

AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.

bimatoprost ophthalmic solution 0.03%

Drug

Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.

Other names: Lumigan®

AGN-210669 vehicle ophthalmic solution

Drug

AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.

Primary outcomes

  1. Change From Baseline in Average Eye Intraocular Pressure (IOP)

    Time frame: Baseline, Day 14 Hour 0

    IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).

Secondary outcomes

  1. Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP

    Time frame: Baseline, Day 14

    IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP is the average of the IOP values of both eyes at each time point measured at protocol-specified times throughout the day.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 17, 2008
Registry last updated
Oct 18, 2013

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.