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

NCT01001195 | Completed Phase 2 Results

• 1 other identifier: 210669-010
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

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®).

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Average Eye Intraocular Pressure (IOP)

  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).

  Baseline, Day 29 Hour 0

Study Arms (4)

AGN-210669 ophthalmic solution, 0.1%

EXPERIMENTAL

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.

Drug: AGN-210669 ophthalmic solution, 0.1%

AGN-210669 ophthalmic solution, 0.075%

EXPERIMENTAL

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.

Drug: AGN-210669 ophthalmic solution, 0.075%

AGN-210669 ophthalmic solution, 0.05%

EXPERIMENTAL

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.

Drug: AGN-210669 ophthalmic solution, 0.05%

bimatoprost ophthalmic solution 0.03%

ACTIVE COMPARATOR

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.

Drug: bimatoprost ophthalmic solution 0.03%

Interventions

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, 0.1%

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, 0.075%

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.

AGN-210669 ophthalmic solution, 0.05%

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.

Also known as: LUMIGAN®

bimatoprost ophthalmic solution 0.03%

Eligibility Criteria

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

You may qualify if:

• Ocular hypertension or primary open-angle glaucoma in each eye
• Patient requires IOP lowering medication in each eye

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Rochester, New York, 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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: October 26, 2009
• Study Start: November 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: October 18, 2013
• Results First Posted: October 18, 2013

Record last verified: 2013-08

Locations

US (1)