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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00809848
First received: December 16, 2008
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Ocular Hypertension
Glaucoma
Drug: AGN-210669 ophthalmic solution, 0.075%
Drug: AGN-210669 ophthalmic solution, 0.05%
Drug: AGN-210669 ophthalmic solution, 0.025%
Drug: bimatoprost ophthalmic solution 0.03%
Drug: AGN-210669 vehicle ophthalmic solution
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 14 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).


Secondary Outcome Measures:
  • Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP [ Time Frame: Baseline, Day 14 ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP is the average of the IOP values of both eyes at each time point measured at protocol-specified times throughout the day.


Enrollment: 172
Study Start Date: February 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AGN-210669 ophthalmic solution, 0.075%
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 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
Experimental: AGN-210669 ophthalmic solution, 0.05%
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 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
Experimental: AGN-210669 ophthalmic solution, 0.025%
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%
AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
Active Comparator: bimatoprost ophthalmic solution 0.03%
Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
Drug: bimatoprost ophthalmic solution 0.03%
Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
Other Name: Lumigan®
Placebo Comparator: AGN-210669 vehicle ophthalmic solution
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
AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809848

Locations
United States, California
Artesia, California, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00809848     History of Changes
Other Study ID Numbers: 210669-003
Study First Received: December 16, 2008
Results First Received: August 13, 2013
Last Updated: August 13, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 16, 2014