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

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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 )

Brief Summary:
Study of safety and efficacy of UNR844 in subjects with presbyopia.

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 235 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Double-masked, Multi-center, Dose-ranging Study to Evaluate the Safety, and Efficacy of UNR844 in Subjects With Presbyopia
Actual Study Start Date : June 30, 2021
Actual Primary Completion Date : July 27, 2022
Estimated Study Completion Date : September 27, 2022

Arm Intervention/treatment
Experimental: UNR844 Low
UNR844 Low ophthalmic solution; one drop twice-a-day for three months
Drug: UNR844
Ophthalmic solution for topical ocular administration
Other Name: EV06

Experimental: UNR844 Medium 1
UNR844 Medium 1 ophthalmic solution; one drop twice-a-day for three months
Drug: UNR844
Ophthalmic solution for topical ocular administration
Other Name: EV06

Experimental: UNR844 Medium 2
UNR844 Medium 2 ophthalmic solution; one drop twice-a-day for three months
Drug: UNR844
Ophthalmic solution for topical ocular administration
Other Name: EV06

Experimental: UNR844 High
UNR844 High ophthalmic solution; one drop twice-a-day for three months
Drug: UNR844
Ophthalmic solution for topical ocular administration
Other Name: EV06

Placebo Comparator: Placebo Ophthalmic Solution
placebo ophthalmic solution; one drop twice-a-day for three months
Drug: Placebo
Placebo
Other Name: Vehicle




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  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 [ 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.



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Ages Eligible for Study:   45 Years to 55 Years   (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): NCT04806503


Locations
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United States, California
Novartis Investigative Site
Laguna Hills, California, United States, 92653
Novartis Investigative Site
Newport Beach, California, United States, 92660
Novartis Investigative Site
Newport Beach, California, United States, 92663
United States, Florida
Novartis Investigative Site
Largo, Florida, United States, 33773
United States, Illinois
Novartis Investigative Site
Lake Villa, Illinois, United States, 60046
United States, Kansas
Novartis Investigative Site
Pittsburg, Kansas, United States, 66762
United States, Missouri
Novartis Investigative Site
Washington, Missouri, United States, 63090
United States, Pennsylvania
Novartis Investigative Site
Kingston, Pennsylvania, United States, 18704
United States, South Dakota
Novartis Investigative Site
Sioux Falls, South Dakota, United States, 57108
United States, Tennessee
Novartis Investigative Site
Memphis, Tennessee, United States, 38119
Novartis Investigative Site
Smyrna, Tennessee, United States, 37167
United States, Texas
Novartis Investigative Site
San Antonio, Texas, United States, 78229
Australia, New South Wales
Novartis Investigative Site
Sydney, New South Wales, Australia, 2052
Australia, Victoria
Novartis Investigative Site
East Melbourne, Victoria, Australia, 3002
Canada, British Columbia
Novartis Investigative Site
Vancouver, British Columbia, Canada, V6H 1H6
Canada, Ontario
Novartis Investigative Site
Kitchener, Ontario, Canada, N2A 0K5
Novartis Investigative Site
Waterloo, Ontario, Canada, N2L3G1
Canada
Novartis Investigative Site
Quebec, Canada, G1S 4L8
Japan
Novartis Investigative Site
Suita-city, Osaka, Japan, 565-0853
Novartis Investigative Site
Shinjuku ku, Tokyo, Japan, 160-0008
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: NCT04806503    
Other Study ID Numbers: CUNR844A2202
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: September 15, 2022
Last Verified: September 2022
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.

This trial data availability is according to the criteria and process described on 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 ):
loss of elasticity in lens
lens
lens disorder
loss of near vision
Presbyopia
UNR844
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases