Phase 2 N=125 Randomized Quadruple-blind Treatment

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

Glaucoma, Open-Angle · Ocular Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01291108 ↗

Enrolled (actual)

125

Serious AEs

0.4%

Results posted

Nov 2013

Primary outcome: Primary: Change From Baseline in Average Eye IOP — 26.16; 25.98; 26.26; 23.91 Millimeters of Mercury (mmHg)

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AGN-210669 (Drug); bimatoprost (Drug); bimatoprost vehicle (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Oct 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Average Eye IOP	26.16; 25.98; 26.26; 23.91; 23.82; 23.85	—
SECONDARY Change From Baseline in Worse Eye IOP	26.56; 26.40; 26.61; 24.60; 24.25; 24.31	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01291108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.