- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05665387
Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia (OPSIS)
August 21, 2023 updated by: Santen Inc.
OPSIS: A Phase IIa, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia
This is a Phase IIa study to assess efficacy and safety of STN1013600 ophthalmic solution (0.1%, and 0.3 %), twice daily when compared to Placebo in subjects diagnosed with presbyopia.
This study will consist of a Screening Period of up to 15 days followed by a 2 Month Treatment Period.
After the Treatment Period subjects will be followed for a one-month treatment free period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
79
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Santen Inc Clinical Operations
- Phone Number: 415-268-9100
- Email: clinicaltrials@santen.com
Study Locations
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California
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Glendale, California, United States, 91204
- Global Research Management Inc
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Newport Beach, California, United States, 92663
- Eye Research Foundation
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Georgia
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Morrow, Georgia, United States, 30260
- Clayton Eye Clinical Research, LLC
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Missouri
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Washington, Missouri, United States, 63090
- Comprehensive Eye Care, Ltd
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New York
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Rochester, New York, United States, 14618
- Rochester Ophthalmological Group, P.C.
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North Carolina
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Asheville, North Carolina, United States, 28803
- Asheville Eye Associates
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Pennsylvania
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Cranberry Township, Pennsylvania, United States, 16066
- Scott Christie and Associates PC
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South Dakota
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Sioux Falls, South Dakota, United States, 57108
- Vance Thompson Vision Clinic
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Tennessee
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Maryville, Tennessee, United States, 37803
- University Eye Specialists
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Memphis, Tennessee, United States, 38119
- Total Eye Care PA
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Texas
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El Paso, Texas, United States, 79902
- The Cataract and Glaucoma Center
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San Antonio, Texas, United States, 78229
- R and R Eye Research LLC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
47 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Phakic presbyopic subjects, Male or Female between 47 and 55 years of age.
- 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:
- Secondary cause of presbyopia in either eye as assessed by investigator (e.g., damage to lens, zonules or ciliary muscle, multiple sclerosis, cardiovascular accidents, vascular insufficiency, myasthenia gravis, anemia, influenza, measles).
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 0.1% STN1013600 ophthalmic solution
0.1% STN1013600 ophthalmic solution 1 drop BID
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0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months
|
Experimental: 0.3% STN1013600 ophthalmic solution
0.3% STN1013600 ophthalmic solution 1 drop BID
|
0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months
|
Placebo Comparator: Placebo (Vehicle) ophthalmic solution
Placebo (Vehicle) ophthalmic solution BID
|
Placebo ophthalmic solution 1 drop BID for 2 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean change from baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA)
Time Frame: at Month 2
|
at Month 2
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean change from baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at all visits
Time Frame: at Day 7, Day 14, Month 1, Month 2 and Month 3
|
at Day 7, Day 14, Month 1, Month 2 and Month 3
|
Proportion of subjects who improve 1/2/3-lines or more in Study Eye and Binocular Distance Corrected Near Visual Acuity (DCNVA)
Time Frame: at Day 7, Day 14, Month 1, Month 2 and Month 3
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at Day 7, Day 14, Month 1, Month 2 and Month 3
|
Mean change from baseline in quality of life assessed with Near Activity Visual Questionnaire (NAVQ)
Time Frame: Month 2 and Month 3
|
Month 2 and Month 3
|
Subject treatment satisfaction as assessed by Patient Global Rating of Treatment
Time Frame: Month 2
|
Month 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 21, 2022
Primary Completion (Actual)
July 27, 2023
Study Completion (Actual)
July 27, 2023
Study Registration Dates
First Submitted
December 16, 2022
First Submitted That Met QC Criteria
December 16, 2022
First Posted (Actual)
December 27, 2022
Study Record Updates
Last Update Posted (Actual)
August 23, 2023
Last Update Submitted That Met QC Criteria
August 21, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 101360002IN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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