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

NCT01291108 | Completed Phase 2 Results

• 1 other identifier: 210669-013
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Average Eye IOP

  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.

  Baseline, Day 57

Secondary Outcomes (1)

• Change From Baseline in Worse Eye IOP

  Baseline, Day 57

Study Arms (6)

AGN-210669

EXPERIMENTAL

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

Drug: AGN-210669

AGN-210669 + bimatoprost

EXPERIMENTAL

AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.

Drug: AGN-210669; Drug: bimatoprost

AGN-210669 + bimatoprost vehicle

EXPERIMENTAL

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.

Drug: AGN-210669; Drug: bimatoprost vehicle

bimatoprost

ACTIVE COMPARATOR

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

Drug: bimatoprost

bimatoprost + AGN-210669

EXPERIMENTAL

bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.

Drug: AGN-210669; Drug: bimatoprost

bimatoprost + bimatoprost vehicle

OTHER

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.

Drug: bimatoprost; Drug: bimatoprost vehicle

Interventions

AGN-210669 DRUG

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

AGN-210669; AGN-210669 + bimatoprost; AGN-210669 + bimatoprost vehicle; bimatoprost + AGN-210669

bimatoprost DRUG

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

Also known as: LUMIGAN®

AGN-210669 + bimatoprost; bimatoprost; bimatoprost + AGN-210669; bimatoprost + bimatoprost vehicle

bimatoprost vehicle DRUG

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

AGN-210669 + bimatoprost vehicle; bimatoprost + bimatoprost vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Austin, Texas, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Bimatoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2011
• First Posted: February 8, 2011
• Study Start: April 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 6, 2013
• Results First Posted: November 6, 2013

Record last verified: 2013-11

Locations

US (1)