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

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Allergan

Status and phase

Completed
Phase 2

Conditions

Ocular Hypertension
Glaucoma, Open-Angle

Treatments

Drug: AGN-210669
Drug: bimatoprost vehicle
Drug: bimatoprost

Study type

Interventional

Funder types

Industry

Identifiers

NCT01291108
210669-013

Details and patient eligibility

About

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.

Enrollment

125 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

125 participants in 6 patient groups

AGN-210669
Experimental group
Description:
AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.
Treatment:
Drug: AGN-210669
AGN-210669 + bimatoprost
Experimental group
Description:
AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.
Treatment:
Drug: bimatoprost
Drug: AGN-210669
AGN-210669 + bimatoprost vehicle
Experimental group
Description:
AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
Treatment:
Drug: bimatoprost vehicle
Drug: AGN-210669
bimatoprost
Active Comparator group
Description:
bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.
Treatment:
Drug: bimatoprost
bimatoprost + AGN-210669
Experimental group
Description:
bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.
Treatment:
Drug: bimatoprost
Drug: AGN-210669
bimatoprost + bimatoprost vehicle
Other group
Description:
bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
Treatment:
Drug: bimatoprost vehicle
Drug: bimatoprost

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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