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

NCT ID: NCT03809611

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-26
• Study Completion Date: 2019-12-16

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.

Conditions

Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

UNR844-Cl Ophthalmic Solution

1.5% UNR844-Cl ophthalmic solution for twice-daily dosing

Group Type: EXPERIMENTAL

UNR844-Cl

Intervention Type: DRUG

1.5% Ophthalmic solution for topical ocular administration

Placebo Ophthalmic Solution

placebo ophthalmic solution for twice-daily dosing

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo

Interventions

UNR844-Cl

1.5% Ophthalmic solution for topical ocular administration

Intervention Type: DRUG

Placebo

placebo

Intervention Type: DRUG

Other Intervention Names

Lipoic acid choline ester chloride, EV06; Vehicle

Eligibility 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Mission Hills, California, United States

Novartis Investigative Site

Newport Beach, California, United States

Novartis Investigative Site

Largo, Florida, United States

Novartis Investigative Site

Mt. Dora, Florida, United States

Novartis Investigative Site

Washington, Missouri, United States

Novartis Investigative Site

Allenwood, Pennsylvania, United States

Novartis Investigative Site

Cranberry Township, Pennsylvania, United States

Novartis Investigative Site

Kingston, Pennsylvania, United States

Novartis Investigative Site

Memphis, Tennessee, United States

Novartis Investigative Site

Nashville, Tennessee, United States

Novartis Investigative Site

Nashville, Tennessee, United States

Novartis Investigative Site

Cedar Park, Texas, United States

Novartis Investigative Site

Houston, Texas, United States

Novartis Investigative Site

Norfolk, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CUNR844A2203

Identifier Type: -

Identifier Source: org_study_id