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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Presbyopia

Treatments: Drug: UNR844; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04806503

CUNR844A2202

Details and patient eligibility

About

Study of safety and efficacy of UNR844 in subjects with presbyopia.

Full description

This was a randomized, placebo-controlled, double-masked,multi-arm, parallel-group, multi-center 13-month study which consisted of:

• A 1 week run-in period
• A 3-month treatment course with UNR844 and/or Placebo
• A 9-month treatment holiday period Participants were randomized equally to one of five treatment arms: UNR844 5 mg/mL,UNR844 13.3 mg/mL, UNR844 23 mg/mL, UNR844 30 mg/mL, or Placebo eye drops twice-a-day for three months.

Participants underwent a 1 week run-in period where they were assessed for entry criteria during the Screening visit. During the run-in period, participants self-administered 1 drop of artificial tears twice-a-day (1 drop in the morning and 1 drop in the evening) in each eye at home. This run-in period was designed to help minimize any potential variability in distance corrected near visual acuity (DCNVA) caused due to initial ocular surface issues and help to establish an accurate baseline prior to randomization. The run-in period was to help exclude participants with a change in DCNVA of 0.10 logMAR difference between Screening and Baseline.

This study was conducted to determine the optimum dose of UNR844 treatment and the duration of effect of UNR844 treatment for further development.

Enrollment: 234 patients

Sex: All

Ages: 45 to 55 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: Triple Blind

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234 participants in 5 patient groups, including a placebo group

UNR844 5 mg/mL

Experimental group

Description:

UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months

Treatment:

Drug: UNR844

UNR844 13.3 mg/mL

Experimental group

Description:

UNR844 13.3 mg/mL 1 ophthalmic solution; one drop twice-a-day for three months

Treatment:

Drug: UNR844

UNR844 23 mg/mL

Experimental group

Description:

UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months

Treatment:

Drug: UNR844

UNR844 30 mg/mL

Experimental group

Description:

UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months

Treatment:

Drug: UNR844

Placebo Ophthalmic Solution

Placebo Comparator group

Description:

placebo ophthalmic solution; one drop twice-a-day for three months

Treatment:

Drug: Placebo