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

• ClinicalTrials.gov Identifier: NCT04806503
• Recruitment Status: Active, not recruiting
• First Posted: March 19, 2021
• Last Update Posted: June 14, 2022
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Study Description

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

Study Design

• 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
• Estimated Primary Completion Date: August 1, 2022
• Estimated Study Completion Date: April 10, 2023

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

More Information

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04806503
• Other Study ID Numbers: CUNR844A2202
• First Posted: March 19, 2021
• Last Update Posted: June 14, 2022
• Last Verified: June 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/.

• 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:

Presbyopia; Refractive Errors; Eye Diseases