Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia
NCT ID: NCT05665387
Last Updated: 2024-05-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
79 participants
INTERVENTIONAL
2022-12-22
2023-07-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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0.1% STN1013600 ophthalmic solution
0.1% STN1013600 ophthalmic solution 1 drop BID
0.1% STN1013600 ophthalmic solution
0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months
0.3% STN1013600 ophthalmic solution
0.3% STN1013600 ophthalmic solution 1 drop BID
0.3% STN1013600 ophthalmic solution
0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months
Placebo (Vehicle) ophthalmic solution
Placebo (Vehicle) ophthalmic solution BID
Placebo
Placebo ophthalmic solution 1 drop BID for 2 months
Interventions
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0.1% STN1013600 ophthalmic solution
0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months
0.3% STN1013600 ophthalmic solution
0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months
Placebo
Placebo ophthalmic solution 1 drop BID for 2 months
Eligibility Criteria
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Inclusion Criteria
* Distance-corrected near visual acuity (DCNVA) for each eye, as well as for binocular vision, 70 EDTRS letters or worse (equivalent to 0.3 logMAR or worse; or 20/40 Snellen or worse) at 40 cm. To be reconfirmed at Visit 2 (Baseline).
* Best-corrected distance visual acuity (BCDVA) for each eye of 85 ETDRS letters or better (equivalent to 0.00 logMAR or better; or 20/20 Snellen or better) at 4 m. To be reconfirmed at Visit 2 (Baseline).
Exclusion Criteria
* Any history of ocular surgery (including ocular laser surgery) in either eye or plan of ocular surgery (including ocular laser surgery) during the course of the study.
* Prior invasive therapy for presbyopia (e.g., ciliary body electrostimulation, corneal implants).
47 Years
55 Years
ALL
No
Sponsors
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Santen Inc.
INDUSTRY
Responsible Party
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Locations
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Global Research Management Inc
Glendale, California, United States
Eye Research Foundation
Newport Beach, California, United States
Clayton Eye Clinical Research, LLC
Morrow, Georgia, United States
Comprehensive Eye Care, Ltd
Washington, Missouri, United States
Rochester Ophthalmological Group, P.C.
Rochester, New York, United States
Asheville Eye Associates
Asheville, North Carolina, United States
Scott Christie and Associates PC
Cranberry Township, Pennsylvania, United States
Vance Thompson Vision Clinic
Sioux Falls, South Dakota, United States
University Eye Specialists
Maryville, Tennessee, United States
Total Eye Care PA
Memphis, Tennessee, United States
The Cataract and Glaucoma Center
El Paso, Texas, United States
R and R Eye Research LLC
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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101360002IN
Identifier Type: -
Identifier Source: org_study_id
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