Clinical trial NCT04806503: A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia.
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Presbyopia
Keywords: loss of elasticity in lens
lens
lens disorder
loss of near vision
Presbyopia
UNR844
farsightedness
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-03-19
Enrollment: 234
Sex: ALL
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

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

Primary outcomes:
measure: Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3
timeFrame: Baseline, Month 3
Secondary outcomes:
measure: Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3
timeFrame: Baseline, Month 3
measure: Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3
timeFrame: Baseline, Month 3
measure: Percentage of Participants Gaining at Least 0.30 logMAR in Binocular Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3
timeFrame: Baseline, Month 3
measure: Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3
timeFrame: Baseline, Month 3
measure: Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3
timeFrame: Baseline, Month 3
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Novartis Investigative Site
state: California
city: Newport Beach
country: United States
facility: Novartis Investigative Site
state: California
city: Newport Beach
country: United States
facility: Novartis Investigative Site
state: California
city: Largo
country: United States
facility: Novartis Investigative Site
state: Florida
city: Lake Villa
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Pittsburg
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Washington
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Kingston
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Novartis Investigative Site
state: South Dakota
city: Memphis
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Smyrna
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: Sydney
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: East Melbourne
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Kitchener
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Waterloo
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Suita-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Shinjuku ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: