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OpenTrials
Completed

NCT Number: NCT01291108

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

This study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution compared with bimatoprost ophthalmic solution (Lumigan®) as monotherapy and adjunctive therapy in patients with primary open-angle glaucoma or ocular hypertension.

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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

Austin, Texas, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of primary open-angle glaucoma or ocular hypertension in each eye
  • Requires bilateral treatment with an IOP-lowering medication
  • Best corrected visual acuity of 20/100 or better in each eye

Exclusion criteria

  • Use of oral, intramuscular, intravenous or topical ophthalmic corticosteroids within 2 months
  • Inability to fast for up to 10 hours
  • Prior refractive laser surgery (eg, LASIK, radial keratectomy, photorefractive keratectomy)
  • Intraocular surgery or IOP-lowering laser surgery (eg, laser trabeculoplasty) within 6 months
  • Current or anticipated use of artificial tears or any ocular medications aside from study medications during study
  • Anticipated wearing of contact lenses during study

Treatment and study plan

AGN-210669

Drug

AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.

Bimatoprost

Drug

bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.

Other names: LUMIGAN®

Bimatoprost Vehicle

Drug

bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2.

Primary outcomes

  1. Change From Baseline in Average Eye IOP

    Time frame: Baseline, Day 57

    IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are 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). Data are recorded at Hours 0, 4, 8, and 12.

Secondary outcomes

  1. Change From Baseline in Worse Eye IOP

    Time frame: Baseline, Day 57

    IOP is a measurement of the fluid pressure inside the eye. The worse eye IOP refers to eye with the worse baseline IOP, which is determined as the eye with the higher mean diurnal IOP at baseline. If both eyes have the same mean diurnal IOP at baseline, the right eye is designated as the worse eye. 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). Data are recorded at Hours 0, 4, 8, and 12.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 8, 2011
Registry last updated
Nov 6, 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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