4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / A Study of Safety and Efficacy of UNR844 Chloride (UNR844-Cl) Eye Drops in Subjects With Presbyopia.

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

Study Description
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.
Study Design
Layout table for study information
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
Arms and Interventions
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

Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
Layout table for location information
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
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Tracking Information
First Submitted Date  ICMJE January 17, 2019
First Posted Date  ICMJE January 18, 2019
Results First Submitted Date  ICMJE September 28, 2020
Results First Posted Date  ICMJE November 27, 2020
Last Update Posted Date November 27, 2020
Actual Study Start Date  ICMJE April 26, 2019
Actual Primary Completion Date December 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2020)
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.
Original 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2020)
  • 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.
  • 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.
Original 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
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 was 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 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.
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% Ophthalmic solution for topical ocular administration
    Other Name: Lipoic acid choline ester chloride, EV06
  • Drug: Placebo
    placebo
    Other Name: Vehicle
Study Arms  ICMJE
  • Experimental: UNR844-Cl Ophthalmic Solution
    1.5% UNR844-Cl ophthalmic solution for twice-daily dosing
    Intervention: Drug: UNR844-Cl
  • Placebo Comparator: Placebo Ophthalmic Solution
    placebo ophthalmic solution for twice-daily dosing
    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 Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2020)
125
Original Estimated Enrollment  ICMJE
 (submitted: January 17, 2019)
120
Actual Study Completion Date  ICMJE December 16, 2019
Actual Primary Completion Date December 16, 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
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
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
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/
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 November 2020

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