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

NCT00809848 | Completed Phase 1 Results

• 1 other identifier: 210669-003
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

The study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution in comparison with AGN-210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each morning, in subjects with ocular hypertension or primary open-angle glaucoma. Subjects will be followed for 2 weeks.

Conditions

Ocular Hypertension; Glaucoma

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 14 Hour 0

Secondary Outcomes (1)

• Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP

  Baseline, Day 14

Study Arms (5)

AGN-210669 ophthalmic solution, 0.075%

EXPERIMENTAL

AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.

Drug: AGN-210669 ophthalmic solution, 0.075%

AGN-210669 ophthalmic solution, 0.05%

EXPERIMENTAL

AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.

Drug: AGN-210669 ophthalmic solution, 0.05%

AGN-210669 ophthalmic solution, 0.025%

EXPERIMENTAL

AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.

Drug: AGN-210669 ophthalmic solution, 0.025%

bimatoprost ophthalmic solution 0.03%

ACTIVE COMPARATOR

Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.

Drug: bimatoprost ophthalmic solution 0.03%

AGN-210669 vehicle ophthalmic solution

PLACEBO COMPARATOR

AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.

Drug: AGN-210669 vehicle ophthalmic solution

Interventions

AGN-210669 ophthalmic solution, 0.075% DRUG

AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.

AGN-210669 ophthalmic solution, 0.075%

AGN-210669 ophthalmic solution, 0.05% DRUG

AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.

AGN-210669 ophthalmic solution, 0.05%

AGN-210669 ophthalmic solution, 0.025% DRUG

AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.

AGN-210669 ophthalmic solution, 0.025%

bimatoprost ophthalmic solution 0.03% DRUG

Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.

Also known as: Lumigan®

bimatoprost ophthalmic solution 0.03%

AGN-210669 vehicle ophthalmic solution DRUG

AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.

AGN-210669 vehicle ophthalmic solution

Eligibility Criteria

• Age: 18 Years - 75 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
• Females of non-childbearing potential
• Subject requires IOP-lowering therapy in both eyes
• IOP ≥ 22 mm Hg and ≤ 34 mm Hg
• Has a visual acuity score of 20/100 or better in each eye

You may not qualify if:

• Uncontrolled systemic disease
• Active ocular disease
• Alteration of existing chronic systemic medications
• Known allergy or sensitivity to the study medications
• Ophthalmic corticosteroids
• Visual field loss which in the opinion of the investigator is functionally significant
• History of ocular laser, intraocular surgery, or refractive surgery

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Artesia, California, United States

Location

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma

Interventions

Bimatoprost

Condition Hierarchy (Ancestors)

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 1
• 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: December 16, 2008
• First Posted: December 17, 2008
• Study Start: February 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: October 18, 2013
• Results First Posted: October 18, 2013

Record last verified: 2013-08

Locations

US (1)