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A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04806503
Recruitment Status : Active, not recruiting
First Posted : March 19, 2021
Last Update Posted : September 15, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE March 16, 2021
First Posted Date  ICMJE March 19, 2021
Last Update Posted Date September 15, 2022
Actual Study Start Date  ICMJE June 30, 2021
Actual Primary Completion Date July 27, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2021)
Characterize dose-response of UNR844 for change from baseline in binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3 [ Time Frame: Month 3 ]
Characterize dose-response of UNR844 for change from baseline in binocular DCNVA at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refractive errors. Low logMAR score represent good vision while a high logMAR score represent bad vision.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2021)
  • Characterize dose response of UNR844 as measured by change from baseline in monocular DCNVA at Month 3 [ Time Frame: Month 3 ]
    Characterize dose response of UNR844 as measured by change from baseline in monocular DCNVA in logMAR, at 40 cm at Month 3. Low logMAR score represent good vision while a high logMAR score represent bad vision.
  • Assess the duration of effect using change in DCNVA after Month 3 with various dose concentrations of UNR844 [ Time Frame: Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11 and Month 12 ]
    Binocular and monocular DCNVA measured in logMAR, at 40 cm monthly after treatment cessation at Month3. Low logMAR score represent good vision while a high logMAR score represent bad vision.
  • Evaluate the efficacy of improving DCNVA in presbyopic participants, as measured by proportion of participants gaining at least 0.3 logMAR DCNVA at Month 3 [ Time Frame: Month 3 ]
    Proportion of participants gaining at least 0.3 logMAR in binocular and monocular DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refractive errors. Low logMAR score represent good vision while a high logMAR score represent bad vision.
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 Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia.
Official Title  ICMJE A Randomized, Placebo-controlled, Double-masked, Multi-center, Dose-ranging Study to Evaluate the Safety, and Efficacy of UNR844 in Subjects With Presbyopia
Brief Summary Study of safety and efficacy of UNR844 in subjects with presbyopia.
Detailed Description

This is a multi-center, double-masked, placebo-controlled, randomized, parallel-group study. The total duration of the study is approximately 13 months. Approximately 225 presbyopic participants will be enrolled into the study.

Presbyopic participants aged 45 to 55 years are the primary age group in this study.

Screening and Baseline: Participants will be screened for eligibility followed by a baseline visit after which they will be randomized to receive either UNR844 (low, medium 1, medium 2, and high) or Placebo, dosed one drop in each eye twice daily, for 3 months and then will undergo a 9 month treatment holiday period.

Randomized subjects will attend the following study visits after baseline: at Week 2, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11 and Month 12.

The primary objective for the study is to characterize dose-response of UNR844 for change from baseline in binocular DCNVA at Month 3.

There are 3 secondary objectives:

  1. Characterize dose response of UNR844 as measured by change from baseline in monocular DCNVA at Month 3
  2. Assess the duration of effect using change in DCNVA after Month 3 with various dose concentrations of UNR844
  3. Evaluate the efficacy of improving DCNVA in presbyopic participants, as measured by proportion of participants gaining at least 0.3 logMAR DCNVA at Month 3
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Presbyopia
Intervention  ICMJE
  • Drug: UNR844
    Ophthalmic solution for topical ocular administration
    Other Name: EV06
  • Drug: Placebo
    Placebo
    Other Name: Vehicle
Study Arms  ICMJE
  • Experimental: UNR844 Low
    UNR844 Low ophthalmic solution; one drop twice-a-day for three months
    Intervention: Drug: UNR844
  • Experimental: UNR844 Medium 1
    UNR844 Medium 1 ophthalmic solution; one drop twice-a-day for three months
    Intervention: Drug: UNR844
  • Experimental: UNR844 Medium 2
    UNR844 Medium 2 ophthalmic solution; one drop twice-a-day for three months
    Intervention: Drug: UNR844
  • Experimental: UNR844 High
    UNR844 High ophthalmic solution; one drop twice-a-day for three months
    Intervention: Drug: UNR844
  • Placebo Comparator: Placebo Ophthalmic Solution
    placebo ophthalmic solution; one drop twice-a-day for three months
    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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 30, 2022)
235
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2021)
225
Estimated Study Completion Date  ICMJE September 27, 2022
Actual Primary Completion Date July 27, 2022   (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 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04806503
Other Study ID Numbers  ICMJE CUNR844A2202
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.

This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

Current Responsible Party Novartis ( Novartis Pharmaceuticals )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Novartis Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date September 2022

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