Safety and Efficacy of AGN-199201 and AGN-190584 in Patients With Presbyopia

Phase 2

Completed

• Conditions: Presbyopia
• Interventions: Drug: AGN-199201; Drug: AGN-199201 Vehicle; Drug: AGN-190584

• Registration Number: NCT02197806
• Lead Sponsor: Allergan

Brief Summary

A study to evaluate the safety and efficacy of AGN-199201 alone, AGN-190584 alone and concurrent use of AGN-199201 and AGN-190584 in patients with presbyopia (inability to focus for near vision).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-21
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-23
• Primary Completion: 2014-10
• Study Completion: 2014-11
• Status Verified: 2015-10
• Results First Submitted: 2015-10-30
• Results First Submitted QC: 2015-10-30
• Last Update Submitted: 2015-10-30
• Results First Posted: 2015-12-03
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

-Presbyopia in each eye that impacts daily activities.

Exclusion Criteria

• Use of any topical ophthalmic medications, including artificial tears
• Contact lens use in either eye within 14 days or planned use during the study
• History of eye surgery
• Diagnosis of any type of glaucoma or ocular hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AGN-199201	AGN-199201 Vehicle	1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
AGN-190584	AGN-199201 Vehicle	1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
AGN-199201 + AGN-190584 in One Eye	AGN-190584	1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
AGN-199201	AGN-199201	1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
AGN-199201 + AGN-190584 in One Eye	AGN-199201 Vehicle	1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
AGN-199201 + AGN-190584 in One Eye	AGN-199201	1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
AGN-199201 + AGN-190584 in Both Eyes	AGN-199201	1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
AGN-190584	AGN-190584	1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
AGN-199201 + AGN-190584 in Both Eyes	AGN-190584	1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye	Baseline, Day 3	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. The percentages of patients with at least a 2 or more line improvement in UNVA in the non-dominant eye are presented.