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A Study of Safety and Efficacy of UNR844 Chloride (UNR844-Cl) Eye Drops in Subjects With Presbyopia.

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ClinicalTrials.gov Identifier: NCT03809611
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study is to assess the effect of topical UNR844-Cl (lipoic acid choline ester chloride) ophthalmic solution on near visual function in presbyopic subjects.

Condition or disease Intervention/treatment Phase
Presbyopia Drug: UNR844-Cl Drug: Placebo Phase 2

Detailed Description:

This is a randomized, double-masked, placebo-controlled, parallel-group study.

Eligible subjects will be randomized 1:1 to receive either topical lipoic acid choline ester chloride ophthalmic solution 1.5% or placebo, dosed one drop in each eye twice-daily for 3 months.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: double-mask(Investigator, patient)
Primary Purpose: Treatment
Official Title: A 3-month, Randomized, Placebo-controlled, Double-masked, Multi-center Study to Evaluate the Safety and Efficacy of Topical Ocular UNR844-Cl in Subjects With Presbyopia
Actual Study Start Date : April 26, 2019
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : December 4, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Chlorine

Arm Intervention/treatment
Active Comparator: UNR844-Cl
1.5% UNR844-Cl
Drug: UNR844-Cl
1.5% solution
Other Name: Lipoic acid choline ester chloride, EV06

Placebo Comparator: Placebo Ophthalmic Solution
placebo
Drug: Placebo
placebo
Other Name: Vehicle




Primary Outcome Measures :
  1. Change in binocular distance-corrected near visual acuity (DNCVA) from baseline [ Time Frame: 3 Months ]
    Change from baseline in binocular DCNVA in subjects aged 45 to 55 years at Month 3 after UNR844-Cl or placebo treatment


Secondary Outcome Measures :
  1. Proportion of subjects achieving a prespecificed level of binocular distance-corrected near visual acuity [ Time Frame: 3 months ]
    Proportion of subjects aged 45 to 55 years achieving 75 or more ETDRS letters in binocular DCNVA at Month 3 after UNR844-Cl or placebo treatment

  2. Safety of UNR844-Cl [ Time Frame: 3 months ]
    Frequency of treatment emergent adverse events and treatment emergent serious adverse events in all subjects



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent must be obtained before any assessment is performed
  • Impaired near vision in each eye and when using both eyes, without any near correction
  • Need a certain level of near correction

Exclusion Criteria:

  • Impaired distance vision in either eye, with distance correction (if any)
  • Severe short- or long-sightedness
  • Any significant medical or clinical conditions affecting vision, the eyes or general health
  • Other protocol inclusion and exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809611


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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United States, California
Novartis Investigative Site Recruiting
Mission Hills, California, United States, 91345
Novartis Investigative Site Recruiting
Newport Beach, California, United States, 92663
United States, Florida
Novartis Investigative Site Recruiting
Largo, Florida, United States, 33773
Novartis Investigative Site Recruiting
Mount Dora, Florida, United States, 32757
United States, Kentucky
Novartis Investigative Site Recruiting
Lexington, Kentucky, United States, 40517
United States, Missouri
Novartis Investigative Site Recruiting
Washington, Missouri, United States, 63090
United States, Pennsylvania
Novartis Investigative Site Recruiting
Allenwood, Pennsylvania, United States, 17810
Novartis Investigative Site Recruiting
Cranberry Township, Pennsylvania, United States, 16066
Novartis Investigative Site Recruiting
Kingston, Pennsylvania, United States, 18704
United States, Tennessee
Novartis Investigative Site Recruiting
Memphis, Tennessee, United States, 38119
Novartis Investigative Site Recruiting
Nashville, Tennessee, United States, 37205-2013
Novartis Investigative Site Recruiting
Nashville, Tennessee, United States, 37205
United States, Texas
Novartis Investigative Site Recruiting
Cedar Park, Texas, United States, 78613
Novartis Investigative Site Recruiting
Houston, Texas, United States, 77204
United States, Virginia
Novartis Investigative Site Recruiting
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03809611     History of Changes
Other Study ID Numbers: CUNR844A2203
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Presbyopia, adults, randomized study, placebo
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents