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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04806503
Registration number
NCT04806503
Ethics application status
Date submitted
16/03/2021
Date registered
19/03/2021
Date last updated
30/08/2023
Titles & IDs
Public title
A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia.
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Scientific title
A Randomized, Placebo-controlled, Double-masked, Multi-center, Dose-ranging Study to Evaluate the Safety, and Efficacy of UNR844 in Subjects With Presbyopia
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Secondary ID [1]
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CUNR844A2202
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Universal Trial Number (UTN)
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Trial acronym
READER
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Presbyopia
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - UNR844
Treatment: Drugs - Placebo
Experimental: UNR844 5 mg/mL - UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months
Experimental: UNR844 13.3 mg/mL - UNR844 13.3 mg/mL 1 ophthalmic solution; one drop twice-a-day for three months
Experimental: UNR844 23 mg/mL - UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months
Experimental: UNR844 30 mg/mL - UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months
Placebo Comparator: Placebo Ophthalmic Solution - placebo ophthalmic solution; one drop twice-a-day for three months
Treatment: Drugs: UNR844
Ophthalmic solution for topical ocular administration
Treatment: Drugs: Placebo
Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3
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Assessment method [1]
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Characterize dose response of UNR844 as measured by change from baseline at Month 3 in binocular DCNVA (without near correction) in Logarithm of Minimum Angle of Resolution (logMAR), at 40cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.
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Timepoint [1]
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Baseline, Month 3
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Secondary outcome [1]
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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
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Assessment method [1]
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Characterize dose response of UNR844 as measured by change from baseline at Month 3 in monocular (worse-seeing eye) DCNVA in Logarithm of Minimum Angle of Resolution (logMAR), at 40 cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.
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Timepoint [1]
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Baseline, Month 3
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Secondary outcome [2]
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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
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Assessment method [2]
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Characterize dose response of UNR844 as measured by change from baseline at Month 3 in monocular (better-seeing eye) DCNVA in Logarithm of Minimum Angle of Resolution (logMAR), at 40cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.
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Timepoint [2]
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Baseline, Month 3
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Secondary outcome [3]
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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
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Assessment method [3]
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Percentage of participants gaining at least 0.3 logMAR in binocular DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision.
Percentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines.
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Timepoint [3]
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Baseline, Month 3
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Secondary outcome [4]
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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
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Assessment method [4]
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Percentage of participants gaining at least 0.3 logMAR in monocular (worse-seeing eye) DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision.
Percentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines.
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Timepoint [4]
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Baseline, Month 3
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Secondary outcome [5]
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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
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Assessment method [5]
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Percentage of participants gaining at least 0.3 logMAR in monocular (better-seeing eye) DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision.
Percentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines.
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Timepoint [5]
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Baseline, Month 3
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Eligibility
Key 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
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Minimum age
45
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/06/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/10/2022
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Sample size
Target
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Accrual to date
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Final
234
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Sydney
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Recruitment hospital [2]
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Novartis Investigative Site - East Melbourne
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Recruitment postcode(s) [1]
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2052 - Sydney
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Recruitment postcode(s) [2]
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3002 - East Melbourne
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Recruitment outside Australia
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United States of America
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California
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Florida
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Illinois
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Kansas
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Missouri
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Pennsylvania
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South Dakota
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United States of America
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Tennessee
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Texas
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Japan
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State/province [13]
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Osaka
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Country [14]
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Japan
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State/province [14]
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Tokyo
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Study of safety and efficacy of UNR844 in subjects with presbyopia.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04806503
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04806503
Download to PDF