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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 : Not yet recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE January 17, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date January 18, 2019
Estimated Study Start Date  ICMJE April 26, 2019
Estimated Primary Completion Date October 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • 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
  • Safety of UNR844-Cl [ Time Frame: 3 months ]
    Frequency of treatment emergent adverse events and treatment emergent serious adverse events in all subjects
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Safety and Efficacy of UNR844 Chloride (UNR844-Cl) Eye Drops in Subjects With Presbyopia.
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
double-mask(Investigator, patient)
Primary Purpose: Treatment
Condition  ICMJE Presbyopia
Intervention  ICMJE
  • Drug: UNR844-Cl
    1.5% solution
    Other Name: Lipoic acid choline ester chloride, EV06
  • Drug: Placebo
    placebo
    Other Name: Vehicle
Study Arms  ICMJE
  • Active Comparator: UNR844-Cl
    1.5% UNR844-Cl
    Intervention: Drug: UNR844-Cl
  • Placebo Comparator: Placebo Ophthalmic Solution
    placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 17, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 18, 2019
Estimated Primary Completion Date October 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03809611
Other Study ID Numbers  ICMJE CUNR844A2203
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP