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Trial record 1 of 1 for:    NCT03809611 | Presbyopia
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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 : Completed
First Posted : January 18, 2019
Results First Posted : November 27, 2020
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study was 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 was a multi-center, double-masked, placebo-controlled, randomized, parallel-group study. The total duration of the study was approximately 3 months. Approximately 120 presbyopic subjects were to be enrolled into the study.

Presbyopic subjects aged 45 to 55 years were the primary age group in this study.

Screening and Baseline: Subjects were screened for eligibility followed by a baseline visit after which they were randomized to receive either UNR844-Cl (1.5%, equivalent to 1.3% freebase) or Placebo, dosed one drop in each eye twice daily, for 3 months.

Randomized subjects attended the following study visits after baseline: at Week 2, Month 1, Month 2 and Month 3.

The primary objective of this study was to assess the efficacy of UNR844-Cl on binocular distance corrected near visual acuity (DCNVA) in presbyopic subjects aged 45 to 55 years with the primary endpoint being the change from baseline in binocular DCNVA in subjects aged 45 to 55 years at Month 3 after UNR844-Cl or Placebo treatment.

There were two secondary endpoints:

  1. To assess the efficacy of UNR844-Cl on achieving 75 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters in binocular DCNVA in presbyopic subjects aged 45 to 55 years with endpoint being the 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. To assess the safety of UNR844-Cl in presbyopic subjects by the frequency of treatment emergent adverse events (AEs) and treatment emergent serious adverse events (SAEs) in all subjects after UNR844-Cl or Placebo treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 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
Actual Primary Completion Date : December 16, 2019
Actual Study Completion Date : December 16, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Chlorine

Arm Intervention/treatment
Experimental: UNR844-Cl Ophthalmic Solution
1.5% UNR844-Cl ophthalmic solution for twice-daily dosing
Drug: UNR844-Cl
1.5% Ophthalmic solution for topical ocular administration
Other Name: Lipoic acid choline ester chloride, EV06

Placebo Comparator: Placebo Ophthalmic Solution
placebo ophthalmic solution for twice-daily dosing
Drug: Placebo
placebo
Other Name: Vehicle




Primary Outcome Measures :
  1. Change in Binocular Distance-corrected Near Visual Acuity (DNCVA) From Baseline [ Time Frame: Baseline and at Month 3 ]
    Change from baseline in binocular DCNVA in subjects aged 45 to 55 years at Month 3 after UNR844-Cl or placebo treatment. Low contrast (10% contrast) DCNVA at 40 cm is measured binocularly using an electronic visual acuity testing system. This assessment was performed with subjects corrected for any distance refractive errors. The system provided distance-corrected low contrast near visual acuity in an Early Treatment Diabetic Retinopathy Study (ETDRS) letter numerical score. High monocular DCNVA ETDRS letter scores represent good vision; Low monocular DCNVA ETDRS letter scores represent poor vision.


Secondary Outcome Measures :
  1. Number and Percentage of Subjects Aged 45 to 55 Years Achieving 75 or More Early Treatment Diabetic Retinopathy Study (ETDRS) Letters in Binocular DCNVA at Month 3 [ Time Frame: month 3 ]
    Change from baseline in binocular DCNVA in subjects aged 45 to 55 years at Month 3 after UNR844-Cl or placebo treatment. Low contrast (10% contrast) DCNVA at 40 cm is measured binocularly using an electronic visual acuity testing system. This assessment was performed with subjects corrected for any distance refractive errors. The system provided distance-corrected low contrast near visual acuity in an Early Treatment Diabetic Retinopathy Study (ETDRS) letter numerical score. High monocular DCNVA ETDRS letter scores represent good vision; Low monocular DCNVA ETDRS letter scores represent poor vision.

  2. Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation [ Time Frame: 4 months ]
    Frequency of treatment emergent adverse events and treatment emergent serious adverse events in all subjects. Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.



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

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


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

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] July 2, 2019
Statistical Analysis Plan  [PDF] January 15, 2020

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03809611    
Other Study ID Numbers: CUNR844A2203
First Posted: January 18, 2019    Key Record Dates
Results First Posted: November 27, 2020
Last Update Posted: November 27, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
URL: https://www.clinicalstudydatarequest.com/

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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