Condition or disease | Intervention/treatment | Phase |
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Presbyopia | Drug: UNR844-Cl Drug: Placebo | Phase 2 |
This was a multi-center, double-masked, placebo-controlled, randomized, parallel-group study. The total duration of the study was approximately 3 months. Approximately 120 presbyopic subjects were to be enrolled into the study.
Presbyopic subjects aged 45 to 55 years were the primary age group in this study.
Screening and Baseline: Subjects were screened for eligibility followed by a baseline visit after which they were randomized to receive either UNR844-Cl (1.5%, equivalent to 1.3% freebase) or Placebo, dosed one drop in each eye twice daily, for 3 months.
Randomized subjects attended the following study visits after baseline: at Week 2, Month 1, Month 2 and Month 3.
The primary objective of this study was to assess the efficacy of UNR844-Cl on binocular distance corrected near visual acuity (DCNVA) in presbyopic subjects aged 45 to 55 years with the primary endpoint being the change from baseline in binocular DCNVA in subjects aged 45 to 55 years at Month 3 after UNR844-Cl or Placebo treatment.
There were two secondary endpoints:
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 125 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Masking Description: | double-mask(Investigator, patient) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | April 26, 2019 |
Actual Primary Completion Date : | December 16, 2019 |
Actual Study Completion Date : | December 16, 2019 |
Arm | Intervention/treatment |
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Experimental: UNR844-Cl Ophthalmic Solution
1.5% UNR844-Cl ophthalmic solution for twice-daily dosing
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Drug: UNR844-Cl
1.5% Ophthalmic solution for topical ocular administration
Other Name: Lipoic acid choline ester chloride, EV06
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Placebo Comparator: Placebo Ophthalmic Solution
placebo ophthalmic solution for twice-daily dosing
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Drug: Placebo
placebo
Other Name: Vehicle
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Ages Eligible for Study: | 45 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Novartis Investigative Site | |
Mission Hills, California, United States, 91345 | |
Novartis Investigative Site | |
Newport Beach, California, United States, 92663 | |
United States, Florida | |
Novartis Investigative Site | |
Largo, Florida, United States, 33773 | |
Novartis Investigative Site | |
Mount Dora, Florida, United States, 32757 | |
United States, Missouri | |
Novartis Investigative Site | |
Washington, Missouri, United States, 63090 | |
United States, Pennsylvania | |
Novartis Investigative Site | |
Allenwood, Pennsylvania, United States, 17810 | |
Novartis Investigative Site | |
Cranberry Township, Pennsylvania, United States, 16066 | |
Novartis Investigative Site | |
Kingston, Pennsylvania, United States, 18704 | |
United States, Tennessee | |
Novartis Investigative Site | |
Memphis, Tennessee, United States, 38119 | |
Novartis Investigative Site | |
Nashville, Tennessee, United States, 37205-2013 | |
Novartis Investigative Site | |
Nashville, Tennessee, United States, 37205 | |
United States, Texas | |
Novartis Investigative Site | |
Cedar Park, Texas, United States, 78613 | |
Novartis Investigative Site | |
Houston, Texas, United States, 77204 | |
United States, Virginia | |
Novartis Investigative Site | |
Norfolk, Virginia, United States, 23502 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Tracking Information | |||||||
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First Submitted Date ICMJE | January 17, 2019 | ||||||
First Posted Date ICMJE | January 18, 2019 | ||||||
Results First Submitted Date ICMJE | September 28, 2020 | ||||||
Results First Posted Date ICMJE | November 27, 2020 | ||||||
Last Update Posted Date | November 27, 2020 | ||||||
Actual Study Start Date ICMJE | April 26, 2019 | ||||||
Actual Primary Completion Date | December 16, 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Change in Binocular Distance-corrected Near Visual Acuity (DNCVA) From Baseline [ Time Frame: Baseline and at Month 3 ] 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.
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Original Primary Outcome Measures ICMJE |
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
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Study of Safety and Efficacy of UNR844 Chloride (UNR844-Cl) Eye Drops in Subjects With Presbyopia. | ||||||
Official Title ICMJE | 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 | ||||||
Brief Summary | The purpose of this study was to assess the effect of topical UNR844-Cl (lipoic acid choline ester chloride) ophthalmic solution on near visual function in presbyopic subjects. | ||||||
Detailed Description |
This was a multi-center, double-masked, placebo-controlled, randomized, parallel-group study. The total duration of the study was approximately 3 months. Approximately 120 presbyopic subjects were to be enrolled into the study. Presbyopic subjects aged 45 to 55 years were the primary age group in this study. Screening and Baseline: Subjects were screened for eligibility followed by a baseline visit after which they were randomized to receive either UNR844-Cl (1.5%, equivalent to 1.3% freebase) or Placebo, dosed one drop in each eye twice daily, for 3 months. Randomized subjects attended the following study visits after baseline: at Week 2, Month 1, Month 2 and Month 3. The primary objective of this study was to assess the efficacy of UNR844-Cl on binocular distance corrected near visual acuity (DCNVA) in presbyopic subjects aged 45 to 55 years with the primary endpoint being the change from baseline in binocular DCNVA in subjects aged 45 to 55 years at Month 3 after UNR844-Cl or Placebo treatment. There were two secondary endpoints:
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Masking Description: double-mask(Investigator, patient) Primary Purpose: Treatment
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Condition ICMJE | Presbyopia | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
125 | ||||||
Original Estimated Enrollment ICMJE |
120 | ||||||
Actual Study Completion Date ICMJE | December 16, 2019 | ||||||
Actual Primary Completion Date | December 16, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 45 Years to 65 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03809611 | ||||||
Other Study ID Numbers ICMJE | CUNR844A2203 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Novartis ( Novartis Pharmaceuticals ) | ||||||
Study Sponsor ICMJE | Novartis Pharmaceuticals | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Novartis | ||||||
Verification Date | November 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |