A Study of the Concurrent Use of AGN-190584 and AGN-199201 in Participants With Presbyopia

Presbyopia Clinical Trial

Official title:

A Phase 2, Multicenter, Double-masked, Randomized, Vehicle-Controlled, Study of the Concurrent Use of AGN-190584 and AGN-199201 in Patients With Presbyopia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02595528
• Other study ID #: 199201-009
• Status: Completed
• Phase: Phase 2
• Start date: April 29, 2016
• Est. completion date: October 18, 2017

Study information

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

Clinical Trial Summary

This study will identify the optimum concentrations of AGN-199201 and AGN-190584 when dosed in combination once a day for the improvement of uncorrected near visual acuity in participants with presbyopia (inability to focus on items close-up).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: October 18, 2017
• Est. primary completion date: October 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 50 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 AGN-190584 ophthalmic solution doses A, B and C in the eye.
• AGN-190584 vehicle
Vehicle to AGN-190584
• AGN-199201 + AGN-190584 Combination
1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.
• AGN-199201 vehicle
Vehicle to AGN-199201

Locations

Country	Name	City	State
United States	Sall Research Medical Center	Artesia	California
United States	Milton M. Hom, OD, FAAO	Azusa	California
United States	Specialized Eye Care	Baltimore	Maryland
United States	Cleveland Eye Clinic	Brecksville	Ohio
United States	WCCT Global, LLC	Costa Mesa	California
United States	Scott & Christie and Associates, PC	Cranberry Township	Pennsylvania
United States	Hoopes Durrie Rivera Research, LLC	Draper	Utah
United States	Cataract and Glaucoma Center	El Paso	Texas
United States	Price Vision Group	Indianapolis	Indiana
United States	The Eye Centers of Racine & Kenosha	Kenosha	Wisconsin
United States	Corneal Consultants of Colorado, P.C.	Littleton	Colorado
United States	Total Eye Care, PA	Memphis	Tennessee
United States	Clayton Eye Center	Morrow	Georgia
United States	Mid Florida Eye Center	Mount Dora	Florida
United States	The Eye Research Foundation	Newport Beach	California
United States	North Bay Eye Associates, Inc.	Petaluma	California
United States	Martel Eye Medical Group	Rancho Cordova	California
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	West Coast Eye Care	San Diego	California
United States	Comprehensive Eye Care, Ltd	Washington	Missouri

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 Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters	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, Between hour 1 and hour 10 of each of the five 2-day dosing periods