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

October 30, 2015 updated by: Allergan
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newport Beach, California, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: AGN-199201
1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.
Drug: AGN-199201 Vehicle
1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.
Experimental: 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.
Drug: AGN-199201 Vehicle
1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.
Drug: AGN-190584
1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.
Experimental: AGN-199201 + AGN-190584 in One Eye
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.
Drug: AGN-199201
1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.
Drug: AGN-199201 Vehicle
1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.
Drug: AGN-190584
1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.
Experimental: AGN-199201 + AGN-190584 in Both Eyes
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.
Drug: AGN-199201
1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.
Drug: AGN-190584
1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye
Time Frame: 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.
Baseline, Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

July 21, 2014

First Submitted That Met QC Criteria

July 21, 2014

First Posted (Estimate)

July 23, 2014

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

October 30, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199201-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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