Brief 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

163

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Apr 2016

Shorter than P25 for phase_2

Geographic Reach

1 country

20 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.5 years study duration

First Submitted

Initial submission to the registry

November 2, 2015

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed

6 months until next milestone

Study Start

First participant enrolled

April 29, 2016

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2017

Completed

3.2 years until next milestone

Results Posted

Study results publicly available

December 22, 2020

Completed

Last Updated

December 22, 2020

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

November 2, 2015

Results QC Date

October 16, 2020

Last Update Submit

December 1, 2020

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

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

Study Arms (4)

AGN-199201 and AGN-190584 Vehicle

EXPERIMENTAL

Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.

Drug: AGN-199201 ophthalmic solutionDrug: AGN-190584 ophthalmic solutionDrug: AGN-190584 vehicleDrug: AGN-199201 + AGN-190584 CombinationDrug: AGN-199201 vehicle

AGN-199201 and AGN-190584 Dose A

EXPERIMENTAL

Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.

Drug: AGN-199201 ophthalmic solutionDrug: AGN-190584 ophthalmic solutionDrug: AGN-190584 vehicleDrug: AGN-199201 + AGN-190584 CombinationDrug: AGN-199201 vehicle

AGN-199201 and AGN-190584 Dose B

EXPERIMENTAL

Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.

Drug: AGN-199201 ophthalmic solutionDrug: AGN-190584 ophthalmic solutionDrug: AGN-190584 vehicleDrug: AGN-199201 + AGN-190584 CombinationDrug: AGN-199201 vehicle

AGN-199201 and AGN-190584 Dose C

EXPERIMENTAL

Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.

Drug: AGN-199201 ophthalmic solutionDrug: AGN-190584 ophthalmic solutionDrug: AGN-190584 vehicleDrug: AGN-199201 + AGN-190584 CombinationDrug: AGN-199201 vehicle