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UNR844 for Presbyopia (READER Trial)
Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 3
Awards & highlights
READER Trial Summary
This study is evaluating whether a drug called UNR844 can improve vision in people with presbyopia.
READER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, month 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3
Secondary outcome measures
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
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
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
+2 moreREADER Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: UNR844 5 mg/mLExperimental Treatment1 Intervention
UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months
Group II: UNR844 30 mg/mLExperimental Treatment1 Intervention
UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months
Group III: UNR844 23 mg/mLExperimental Treatment1 Intervention
UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months
Group IV: UNR844 13.3 mg/mLExperimental Treatment1 Intervention
UNR844 13.3 mg/mL 1 ophthalmic solution; one drop twice-a-day for three months
Group V: Placebo Ophthalmic SolutionPlacebo Group1 Intervention
placebo ophthalmic solution; one drop twice-a-day for three months
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,858 Previous Clinical Trials
4,197,609 Total Patients Enrolled
1 Trials studying Presbyopia
125 Patients Enrolled for Presbyopia
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Texas
Florida
Michigan
Other
How old are they?
18 - 65
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Novartis Investigative Site: < 48 hours
Average response time
- < 2 Days
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