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Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia (OPSIS)

Primary Purpose

Presbyopia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
0.1% STN1013600 ophthalmic solution
0.3% STN1013600 ophthalmic solution
Placebo
Sponsored by
Santen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring Santen, Presbyopia, Eye

Eligibility Criteria

47 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Global Research Management Inc
  • Eye Research Foundation
  • Clayton Eye Clinical Research, LLC
  • Comprehensive Eye Care, Ltd
  • Rochester Ophthalmological Group, P.C.
  • Asheville Eye Associates
  • Scott Christie and Associates PC
  • Vance Thompson Vision Clinic
  • University Eye Specialists
  • Total Eye Care PA
  • The Cataract and Glaucoma Center
  • R and R Eye Research LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

0.1% STN1013600 ophthalmic solution

0.3% STN1013600 ophthalmic solution

Placebo (Vehicle) ophthalmic solution

Arm Description

0.1% STN1013600 ophthalmic solution 1 drop BID

0.3% STN1013600 ophthalmic solution 1 drop BID

Placebo (Vehicle) ophthalmic solution BID

Outcomes

Primary Outcome Measures

Mean change from baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA)

Secondary Outcome Measures

Mean change from baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at all visits
Proportion of subjects who improve 1/2/3-lines or more in Study Eye and Binocular Distance Corrected Near Visual Acuity (DCNVA)
Mean change from baseline in quality of life assessed with Near Activity Visual Questionnaire (NAVQ)
Subject treatment satisfaction as assessed by Patient Global Rating of Treatment

Full Information

First Posted
December 16, 2022
Last Updated
August 21, 2023
Sponsor
Santen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05665387
Brief Title
Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia
Acronym
OPSIS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 21, 2022 (Actual)
Primary Completion Date
July 27, 2023 (Actual)
Study Completion Date
July 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
Santen, Presbyopia, Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.1% STN1013600 ophthalmic solution
Arm Type
Experimental
Arm Description
0.1% STN1013600 ophthalmic solution 1 drop BID
Arm Title
0.3% STN1013600 ophthalmic solution
Arm Type
Experimental
Arm Description
0.3% STN1013600 ophthalmic solution 1 drop BID
Arm Title
Placebo (Vehicle) ophthalmic solution
Arm Type
Placebo Comparator
Arm Description
Placebo (Vehicle) ophthalmic solution BID
Intervention Type
Drug
Intervention Name(s)
0.1% STN1013600 ophthalmic solution
Intervention Description
0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months
Intervention Type
Drug
Intervention Name(s)
0.3% STN1013600 ophthalmic solution
Intervention Description
0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo ophthalmic solution 1 drop BID for 2 months
Primary Outcome Measure Information:
Title
Mean change from baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA)
Time Frame
at Month 2
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Mean change from baseline in quality of life assessed with Near Activity Visual Questionnaire (NAVQ)
Time Frame
Month 2 and Month 3
Title
Subject treatment satisfaction as assessed by Patient Global Rating of Treatment
Time Frame
Month 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
47 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Global Research Management Inc
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Clayton Eye Clinical Research, LLC
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Comprehensive Eye Care, Ltd
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Rochester Ophthalmological Group, P.C.
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Asheville Eye Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Scott Christie and Associates PC
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Vance Thompson Vision Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
University Eye Specialists
City
Maryville
State/Province
Tennessee
ZIP/Postal Code
37803
Country
United States
Facility Name
Total Eye Care PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
The Cataract and Glaucoma Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
R and R Eye Research LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia

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