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OpenTrials
Completed

NCT Number: NCT01001195

Safety and Efficacy of Three Formulations of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution

This study will evaluate the safety, efficacy and dose-response of AGN-210669. This study will also compare AGN-210669 with bimatoprost ophthalmic solution (LUMIGAN®).

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rochester, New York, 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
  • Patient requires IOP lowering medication in each eye

Exclusion criteria

  • Ocular hyperemia or other ocular surface findings in either eye
  • Active ocular disease
  • Current or anticipated use of any topical ocular medication (including artificial tears) during the study
  • Intraocular surgery within past six months or unilateral cataract surgery.
  • Functionally significant visual field loss
  • Anticipated wearing of contact lenses during study
  • Use of other medications that affect IOP such as glaucoma treating medications, within 2 months of screening visit

Treatment and study plan

AGN-210669 ophthalmic solution, 0.1%

Drug

One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

AGN-210669 ophthalmic solution, 0.075%

Drug

One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

AGN-210669 ophthalmic solution, 0.05%

Drug

One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

bimatoprost ophthalmic solution 0.03%

Drug

One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

Other names: LUMIGAN®

Primary outcomes

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

    Time frame: Baseline, Day 29 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).

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 26, 2009
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.

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