Trial Outcomes & Findings for A Study of Safety and Efficacy of UNR844 Chloride (UNR844-Cl) Eye Drops in Subjects With Presbyopia. (NCT NCT03809611)

Last Updated: 2022-05-11

Results Overview

Change from baseline in binocular DCNVA in subjects aged 45 to 55 years at Month 3 after UNR844-Cl or placebo treatment. Low contrast (10% contrast) DCNVA at 40 cm is measured binocularly using an electronic visual acuity testing system. This assessment was performed with subjects corrected for any distance refractive errors. The system provided distance-corrected low contrast near visual acuity in an Early Treatment Diabetic Retinopathy Study (ETDRS) letter numerical score. High monocular DCNVA ETDRS letter scores represent good vision; Low monocular DCNVA ETDRS letter scores represent poor vision.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

125 participants

Primary outcome timeframe

Baseline and at Month 3

Results posted on

2022-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	UNR844-Cl 1.5% UNR844-Cl	Placebo Ophthalmic Solution placebo
Overall Study STARTED	62	62
Overall Study COMPLETED	61	61
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	UNR844-Cl 1.5% UNR844-Cl	Placebo Ophthalmic Solution placebo
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	UNR844-Cl n=62 Participants 1.5% UNR844-Cl	Placebo Ophthalmic Solution n=62 Participants placebo	Total n=124 Participants Total of all reporting groups
Age, Continuous	53.9 years STANDARD_DEVIATION 4.97 • n=93 Participants	54.2 years STANDARD_DEVIATION 5.01 • n=4 Participants	54.1 years STANDARD_DEVIATION 4.97 • n=27 Participants
Sex: Female, Male Female	40 Participants n=93 Participants	41 Participants n=4 Participants	81 Participants n=27 Participants
Sex: Female, Male Male	22 Participants n=93 Participants	21 Participants n=4 Participants	43 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Black or African American	7 Participants n=93 Participants	8 Participants n=4 Participants	15 Participants n=27 Participants
Race (NIH/OMB) White	50 Participants n=93 Participants	51 Participants n=4 Participants	101 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and at Month 3

Population: All randomized subjects aged 45 to 55 years at baseline

Outcome measures

Outcome measures
Measure	UNR844-Cl n=40 Participants 1.5% UNR844-Cl	Placebo Ophthalmic Solution n=38 Participants placebo
Change in Binocular Distance-corrected Near Visual Acuity (DCNVA) From Baseline	6.1 number of letters read correctly Standard Error 1.24	4.5 number of letters read correctly Standard Error 1.27

SECONDARY outcome

Timeframe: month 3

Population: l randomized subjects aged 45 to 55 years at baseline

Outcome measures

Outcome measures
Measure	UNR844-Cl n=40 Participants 1.5% UNR844-Cl	Placebo Ophthalmic Solution n=38 Participants placebo
Number and Percentage of Subjects Aged 45 to 55 Years Achieving 75 or More Early Treatment Diabetic Retinopathy Study (ETDRS) Letters in Binocular DCNVA at Month 3	10 Participants	6 Participants

SECONDARY outcome

Timeframe: 4 months

Population: All randomized and treated participants

Frequency of treatment emergent adverse events and treatment emergent serious adverse events in all subjects. Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.

Outcome measures

Outcome measures
Measure	UNR844-Cl n=62 Participants 1.5% UNR844-Cl	Placebo Ophthalmic Solution n=62 Participants placebo
Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation Any non-ocular adverse events	11 Participants	2 Participants
Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation Any severe adverse events	0 Participants	0 Participants
Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation Any ocular severe adverse events	0 Participants	0 Participants
Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation Any non-ocular severe adverse events	0 Participants	0 Participants
Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation Any study drug related ocular adverse events	0 Participants	1 Participants
Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation Any adverse events leading to study drug disc.	0 Participants	0 Participants
Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation Any ocular AEs leading to study drug disc.	0 Participants	0 Participants
Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation Any non-ocular AEs leading to study drug disc.	0 Participants	0 Participants
Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation Any serious adverse events	0 Participants	0 Participants
Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation Any non-ocular serious adverse events	0 Participants	0 Participants
Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation Death	0 Participants	0 Participants
Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation Any adverse events (AEs)	14 Participants	5 Participants
Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation Any ocular adverse events	4 Participants	4 Participants
Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation Any study drug related adverse events	4 Participants	1 Participants
Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation Any study drug related non-ocular adverse events	4 Participants	0 Participants
Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation Any ocular serious adverse events	0 Participants	0 Participants
Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation Any study drug related serious adverse events	0 Participants	0 Participants
Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation Any study drug related ocular serious AEs	0 Participants	0 Participants
Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation Any study drug related non-ocular serious AEs	0 Participants	0 Participants

Adverse Events

UNR844-Cl

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Total

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	UNR844-Cl n=62 participants at risk UNR844-Cl	Placebo n=62 participants at risk Placebo	Total n=124 participants at risk Total
Ear and labyrinth disorders Ear pain	1.6% 1/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.00% 0/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.81% 1/124 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.
Eye disorders Blepharitis	1.6% 1/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.00% 0/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.81% 1/124 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.
Eye disorders Conjunctival hyperaemia	1.6% 1/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.00% 0/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.81% 1/124 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.
Eye disorders Lenticular opacities	0.00% 0/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	1.6% 1/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.81% 1/124 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.
Eye disorders Visual impairment	1.6% 1/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.00% 0/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.81% 1/124 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.6% 1/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.00% 0/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.81% 1/124 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.
General disorders Instillation site pain	0.00% 0/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	1.6% 1/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.81% 1/124 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.
General disorders Sensation of foreign body	1.6% 1/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.00% 0/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.81% 1/124 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.
Immune system disorders Drug hypersensitivity	0.00% 0/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	1.6% 1/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.81% 1/124 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.
Infections and infestations Atypical pneumonia	1.6% 1/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.00% 0/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.81% 1/124 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.
Infections and infestations Sinusitis	1.6% 1/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.00% 0/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.81% 1/124 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.
Infections and infestations Urinary tract infection	0.00% 0/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	1.6% 1/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.81% 1/124 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.
Injury, poisoning and procedural complications Chemical burns of eye	0.00% 0/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	1.6% 1/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.81% 1/124 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.
Injury, poisoning and procedural complications Meniscus injury	1.6% 1/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.00% 0/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.81% 1/124 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.
Injury, poisoning and procedural complications Tooth fracture	1.6% 1/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.00% 0/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.81% 1/124 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.
Investigations Vital dye staining cornea present	0.00% 0/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	1.6% 1/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.81% 1/124 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	1.6% 1/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.81% 1/124 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.
Musculoskeletal and connective tissue disorders Arthralgia	1.6% 1/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.00% 0/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.81% 1/124 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	1.6% 1/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.00% 0/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.81% 1/124 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.
Nervous system disorders Dysgeusia	4.8% 3/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.00% 0/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	2.4% 3/124 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.
Nervous system disorders Headache	3.2% 2/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.00% 0/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	1.6% 2/124 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.6% 1/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.00% 0/62 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.	0.81% 1/124 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.