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OpenTrials
Completed

NCT Number: NCT02197806

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

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).

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Newport Beach, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AGN-199201

Drug

1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.

AGN-190584

Drug

1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.

AGN-199201 Vehicle

Drug

1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 23, 2014
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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