Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01291108
First received: February 4, 2011
Last updated: October 17, 2012
Last verified: October 2012
History of Changes
  Purpose

This study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution compared with bimatoprost ophthalmic solution (Lumigan®) as monotherapy and adjunctive therapy in patients with primary open-angle glaucoma or ocular hypertension.


Condition Intervention Phase
Glaucoma, Open-Angle
Ocular Hypertension
 Drug: AGN-210669 0.05%; bimatoprost 0.03% ophthalmic solution
Drug: AGN-210669 0.05%; vehicle of bimatoprost 0.03% ophthalmic solution
Drug: bimatoprost 0.03% ophthalmic solution; AGN-210669 0.05%
Drug: bimatoprost 0.03% ophthalmic solution; vehicle of bimatoprost 0.03% ophthalmic solution
 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:

Drug Information available for: Bimatoprost
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change from Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, Day 57 ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: April 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AGN-210669 0.05%; bimatoprost 0.03% ophthalmic solution
 Drug: AGN-210669 0.05%; bimatoprost 0.03% ophthalmic solution
One drop of AGN-210669 0.05% instilled to each eye every evening for 28 days. One drop of AGN-210669 0.05% followed by one drop of bimatoprost 0.03% ophthalmic solution instilled to each eye every evening for an additional 28 days.
Other Name: LUMIGAN®
Experimental: 2
AGN-210669 0.05%; vehicle of bimatoprost 0.03% ophthalmic solution
 Drug: AGN-210669 0.05%; vehicle of bimatoprost 0.03% ophthalmic solution
One drop of AGN-210669 0.05% instilled to each eye every evening for 28 days. One drop of AGN-210669 0.05% followed by one drop of bimatoprost 0.03% ophthalmic solution vehicle instilled to each eye every evening for an additional 28 days.
Experimental: 3
bimatoprost 0.03% ophthalmic solution; AGN-210669 0.05%
 Drug: bimatoprost 0.03% ophthalmic solution; AGN-210669 0.05%
One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye every evening for 28 days. One drop of bimatoprost 0.03% ophthalmic solution followed by one drop of AGN-210669 0.05% instilled to each eye every evening for an additional 28 days.
Other Name: LUMIGAN®
Active Comparator: 4
bimatoprost 0.03% ophthalmic solution; vehicle of bimatoprost 0.03% ophthalmic solution
 Drug: bimatoprost 0.03% ophthalmic solution; vehicle of bimatoprost 0.03% ophthalmic solution
One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye every evening for 28 days. One drop of bimatoprost 0.03% ophthalmic solution followed by one drop of bimatoprost 0.03% ophthalmic solution vehicle instilled to each eye every evening for an additional 28 days
Other Name: LUMIGAN®

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of primary open-angle glaucoma or ocular hypertension in each eye
  • Requires bilateral treatment with an IOP-lowering medication
  • Best corrected visual acuity of 20/100 or better in each eye

Exclusion Criteria:

  • Use of oral, intramuscular, intravenous or topical ophthalmic corticosteroids within 2 months
  • Inability to fast for up to 10 hours
  • Prior refractive laser surgery (eg, LASIK, radial keratectomy, photorefractive keratectomy)
  • Intraocular surgery or IOP-lowering laser surgery (eg, laser trabeculoplasty) within 6 months
  • Current or anticipated use of artificial tears or any ocular medications aside from study medications during study
  • Anticipated wearing of contact lenses during study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291108

Locations
United States, Texas
Austin, Texas, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01291108     History of Changes
Other Study ID Numbers: 210669-013
Study First Received: February 4, 2011
Last Updated: October 17, 2012
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 May 16, 2013