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Completed

NCT Number: NCT02780115

A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia

This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201 and AGN-190584 in participants with presbyopia (inability to focus on items close-up).

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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

Retina Institute of California Medical Group, Arcadia, California, United States

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

AGN-199201 ophthalmic solution

Drug

1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.

AGN-190584 ophthalmic solution

Drug

1 drop of AGN-190584 ophthalmic solution Doses A, B, C in the eye.

AGN-199201 Vehicle

Drug

Vehicle to AGN-199201

AGN-190584 vehicle

Drug

Vehicle to AGN-190584

Primary outcomes

  1. Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye

    Time frame: Baseline, Day 28

    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.

Secondary outcomes

  1. Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)

    Time frame: up to 65 days

    A Treatment Emergent Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety, Efficacy, and Pharmacokinetics of the Fixed Combination of AGN-199201 and AGN-190584 in Patients With Presbyopia

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 23, 2016
Registry last updated
Dec 22, 2020

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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