A Study of Safety and Efficacy of UNR844 Chloride (UNR844-Cl) Eye Drops in Subjects With Presbyopia.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03809611|
Recruitment Status : Not yet recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Presbyopia||Drug: UNR844-Cl Drug: Placebo||Phase 2|
This is a randomized, double-masked, placebo-controlled, parallel-group study.
Eligible subjects will be randomized 1:1 to receive either topical lipoic acid choline ester chloride ophthalmic solution 1.5% or placebo, dosed one drop in each eye twice-daily for 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||double-mask(Investigator, patient)|
|Official Title:||A 3-month, Randomized, Placebo-controlled, Double-masked, Multi-center Study to Evaluate the Safety and Efficacy of Topical Ocular UNR844-Cl in Subjects With Presbyopia|
|Estimated Study Start Date :||April 26, 2019|
|Estimated Primary Completion Date :||October 18, 2019|
|Estimated Study Completion Date :||October 18, 2019|
Active Comparator: UNR844-Cl
Other Name: Lipoic acid choline ester chloride, EV06
Placebo Comparator: Placebo Ophthalmic Solution
Other Name: Vehicle
- Change in binocular distance-corrected near visual acuity (DNCVA) from baseline [ Time Frame: 3 Months ]Change from baseline in binocular DCNVA in subjects aged 45 to 55 years at Month 3 after UNR844-Cl or placebo treatment
- Proportion of subjects achieving a prespecificed level of binocular distance-corrected near visual acuity [ Time Frame: 3 months ]Proportion of subjects aged 45 to 55 years achieving 75 or more ETDRS letters in binocular DCNVA at Month 3 after UNR844-Cl or placebo treatment
- Safety of UNR844-Cl [ Time Frame: 3 months ]Frequency of treatment emergent adverse events and treatment emergent serious adverse events in all subjects
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809611
|Contact: Novartis Pharmaceuticalsfirstname.lastname@example.org|
|Contact: Novartis Pharmaceuticals|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|