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

Novartis

Status and phase: Completed; Phase 2

Conditions: Presbyopia

Treatments: Drug: UNR844-Cl; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03809611

CUNR844A2203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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125 participants in 2 patient groups, including a placebo group

UNR844-Cl Ophthalmic Solution

Experimental group

Description:

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

Treatment:

Drug: UNR844-Cl

Placebo Ophthalmic Solution

Placebo Comparator group

Description:

placebo ophthalmic solution for twice-daily dosing

Treatment:

Drug: Placebo