Safety and Pharmacodynamics Study of AGN-207281 Ophthalmic Solutions Compared With Timolol Ophthalmic Solution or Placebo in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma

NCT01215786 | Completed Phase 1 Results

• 1 other identifier: 207281-004
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is an exploratory study that will evaluate the safety and pharmacodynamics of up to 3 doses of AGN-207281 based on an ongoing review of data during the study period compared with timolol ophthalmic solution or placebo in patients with ocular hypertension or primary open-angle glaucoma.

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14

  Change from baseline in worse eye IOP at day 14. Worse eye IOP refers to the eye with the worse (highest) baseline IOP (a measurement of the fluid pressure inside the eye). A negative number change from baseline indicates a reduction in IOP (improvement).

  Baseline, Day 14

Secondary Outcomes (2)

• Mean Concentration of AGN-207281 in Plasma at Day 7

  Day 7

• Mean Concentration of AGN-207281 in Plasma at Day 14

  Day 14

Study Arms (3)

AGN-207281 ophthalmic solution

OTHER

AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14

Drug: AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo)

Timolol ophthalmic solution 0.5%

ACTIVE COMPARATOR

timolol ophthalmic solution 0.5%

Drug: timolol ophthalmic solution 0.5%

Placebo

PLACEBO COMPARATOR

AGN-207281 vehicle ophthalmic solution (Placebo)

Drug: AGN-207281 vehicle ophthalmic solution (Placebo)

Interventions

AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo) DRUG

One drop of AGN-207281 ophthalmic solutions (0.1% on Days 1-7 and 0.3% on Days 8-14) instilled to both eyes in the morning followed by one drop of AGN-207281 vehicle ophthalmic solution (placebo) instilled to both eyes in the evening for 13 days.

AGN-207281 ophthalmic solution

timolol ophthalmic solution 0.5% DRUG

One drop of timolol ophthalmic solution 0.5% instilled to both eyes, in the morning for 14 days, and in the evening for 13 days

Timolol ophthalmic solution 0.5%

AGN-207281 vehicle ophthalmic solution (Placebo) DRUG

One drop of AGN-207281 vehicle ophthalmic solution instilled to both eyes, in the morning for 14 days and in the evening for 13 days.

Placebo

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
• Requires IOP-lowering therapy in both eyes
• Visual acuity score of 20/100 or better in each eye

You may not qualify if:

• Experienced significant weight change (over 10 pounds) within 60 days
• History of alcohol or drug addiction
• History of migraines or frequent headaches
• Anticipated wearing of contact lenses during the study
• Required chronic use of ocular medications during study
• Eye surgery within 6 months
• Use of systemic beta blockers (eg, atenolol, propranolol) within 2 months
• Use of oral, intramuscular, intravenous corticosteroids within 21 days
• Use of ophthalmic corticosteroids within 2 months

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Newport Beach, California, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2010
• First Posted: October 7, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 17, 2015
• Results First Posted: January 16, 2012

Record last verified: 2015-07

Locations

US (1)