Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

NCT01110499 | Completed Phase 2 Results

• 1 other identifier: 210961-002
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost ophthalmic solution 0.03% for 4 weeks.

Conditions

Ocular Hypertension; Primary Open-Angle Glaucoma

Outcome Measures

Primary Outcomes (2)

• Part 1: Change From Baseline in Intraocular Pressure (IOP)

  IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups.

  Baseline, Day 7

• Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)

  IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12.

  Baseline, Day 29

Study Arms (8)

Part 1, AGN-210961 Formulation 1

EXPERIMENTAL

AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Drug: AGN-210961 Formulation 1

Part 1, AGN-210961 Formulation 2

EXPERIMENTAL

AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Drug: AGN-210961 Formulation 2

Part 1, AGN-210961 Formulation 3

EXPERIMENTAL

AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Drug: AGN-210961 Formulation 3

Part 1, AGN-210961 Formulation 4

EXPERIMENTAL

AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Drug: AGN-210961 Formulation 4

Part 1, AGN-210961 Formulation 5

EXPERIMENTAL

AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Drug: AGN-210961 Formulation 5

Part 1, AGN-210961 Formulation 6

EXPERIMENTAL

AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Drug: AGN-210961 Formulation 6

Part 2, AGN-210961 Formulation 7

EXPERIMENTAL

AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.

Drug: AGN-210961 Formulation 7

Part 2, bimatoprost ophthalmic solution 0.03%

ACTIVE COMPARATOR

bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.

Drug: bimatoprost ophthalmic solution 0.03%

Interventions

AGN-210961 Formulation 1 DRUG

AGN-210961 Formulation 1 in one eye once daily for 7 days.

Part 1, AGN-210961 Formulation 1

AGN-210961 Formulation 2 DRUG

AGN-210961 Formulation 2 in one eye once daily for 7 days.

Part 1, AGN-210961 Formulation 2

AGN-210961 Formulation 3 DRUG

AGN-210961 Formulation 3 in one eye once daily for 7 days.

Part 1, AGN-210961 Formulation 3

AGN-210961 Formulation 4 DRUG

AGN-210961 Formulation 4 in one eye once daily for 7 days.

Part 1, AGN-210961 Formulation 4

AGN-210961 Formulation 5 DRUG

AGN-210961 Formulation 5 in one eye once daily for 7 days.

Part 1, AGN-210961 Formulation 5

AGN-210961 Formulation 6 DRUG

AGN-210961 Formulation 6 in one eye once daily for 7 days.

Part 1, AGN-210961 Formulation 6

AGN-210961 Formulation 7 DRUG

AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.

Part 2, AGN-210961 Formulation 7

bimatoprost ophthalmic solution 0.03% DRUG

bimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks.

Also known as: LUMIGAN®

Part 2, 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

You may not qualify if:

• Any active ocular disease
• Anticipated wearing of contact lenses during study
• Anticipated use of artificial tears during study
• Contraindication to pupil dilatation

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Newport Beach, California, United States

Location

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle

Interventions

Bimatoprost

Condition Hierarchy (Ancestors)

Eye Diseases; Glaucoma

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, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: April 26, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 5, 2014
• Results First Posted: August 5, 2014

Record last verified: 2014-07

Locations

US (1)