A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia

Presbyopia Clinical Trial

Official title:

A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety, Efficacy, and Pharmacokinetics of the Fixed Combination of AGN-199201 and AGN-190584 in Patients With Presbyopia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02780115
• Other study ID #: 199201-010
• Status: Completed
• Phase: Phase 2
• Start date: May 26, 2016
• Est. completion date: October 31, 2017

Study information

• Verified date: November 2020
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201 and AGN-190584 in participants with presbyopia (inability to focus on items close-up).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 55 Years

Eligibility

Inclusion Criteria:

• Normal vision at distance, either natural or post corneal laser refractive surgery, with presbyopia in each eye and complaints of poor near vision that impacts activities of daily living

Exclusion Criteria:

• Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study

• Corneal abnormalities in either eye that interfere with visual acuity

• History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery or any intraocular surgery

• Diagnosis of glaucoma or ocular hypertension.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Drug:
• AGN-199201 ophthalmic solution
1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.
• AGN-190584 ophthalmic solution
1 drop of AGN-190584 ophthalmic solution Doses A, B, C in the eye.
• AGN-199201 Vehicle
Vehicle to AGN-199201
• AGN-190584 Vehicle
Vehicle to AGN-190584

Locations

Country	Name	City	State
United States	Retina Institute of California Medical Group	Arcadia	California
United States	Sall Research Medical Center	Artesia	California
United States	Specialized Eye Care	Baltimore	Maryland
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Scott & Christie and Associates, PC	Cranberry Township	Pennsylvania
United States	WCCT Global, LLC	Cypress	California
United States	Hoopes Durrie Rivera Research, LLC	Draper	Utah
United States	Cataract and Glaucoma Center	El Paso	Texas
United States	University of Texas Medical Branch	Galveston	Texas
United States	Lugene Eye Institute	Glendale	California
United States	Specialty Eye Care Medical Center	Glendale	California
United States	Silverstein Eye Centers	Louisville	Kentucky
United States	The Eye Care Institute	Louisville	Kentucky
United States	Total Eye Care, PA	Memphis	Tennessee
United States	MedEye Associates	Miami	Florida
United States	Clayton Eye Center	Morrow	Georgia
United States	The Eye Research Foundation	Newport Beach	California
United States	Central Florida Eye Institute	Ocala	Florida
United States	Stanford Eye and Laser Center	Palo Alto	California
United States	Devers Eye Institute	Portland	Oregon
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	R and R Eye Research, LLC	San Antonio	Texas
United States	Center for Sight	Sarasota	Florida
United States	Wolstan and Golberg Eye Associates	Torrance	California
United States	James D. Branch	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye	UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved.	Baseline, Day 28
Secondary	Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)	A Treatment Emergent Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.	up to 65 days