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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01001195
First received: October 22, 2009
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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®).


Condition Intervention Phase
Glaucoma, Open-Angle
Ocular Hypertension
Drug: AGN-210669 ophthalmic solution, 0.1%
Drug: AGN-210669 ophthalmic solution, 0.075%
Drug: AGN-210669 ophthalmic solution, 0.05%
Drug: bimatoprost ophthalmic solution 0.03%
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Average Eye Intraocular Pressure (IOP) [ Time Frame: Baseline, Day 29 Hour 0 ] [ Designated as safety issue: No ]
    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).


Enrollment: 165
Study Start Date: November 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AGN-210669 ophthalmic solution, 0.1%
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%
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.
Experimental: AGN-210669 ophthalmic solution, 0.075%
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%
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.
Experimental: AGN-210669 ophthalmic solution, 0.05%
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%
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.
Active Comparator: bimatoprost ophthalmic solution 0.03%
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%
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.
Other Name: LUMIGAN®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001195

Locations
United States, New York
Rochester, New York, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01001195     History of Changes
Other Study ID Numbers: 210669-010
Study First Received: October 22, 2009
Results First Received: August 13, 2013
Last Updated: August 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Glaucoma
Vascular Diseases
Bimatoprost
Cloprostenol
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents
Cardiovascular Agents
Contraceptive Agents
Contraceptive Agents, Female
Luteolytic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014