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

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: Presbyopia
• Intervention / Treatment: Drug: 0.1% STN1013600 ophthalmic solution; Drug: 0.3% STN1013600 ophthalmic solution; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91204
      • Global Research Management Inc
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Clayton Eye Clinical Research, LLC
  • Missouri
    • Washington, Missouri, United States, 63090
      • Comprehensive Eye Care, Ltd
  • New York
    • Rochester, New York, United States, 14618
      • Rochester Ophthalmological Group, P.C.
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Asheville Eye Associates
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott Christie and Associates PC
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Vance Thompson Vision Clinic
  • Tennessee
    • Maryville, Tennessee, United States, 37803
      • University Eye Specialists
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care PA
  • Texas
    • El Paso, Texas, United States, 79902
      • The Cataract and Glaucoma Center
    • San Antonio, Texas, United States, 78229
      • R and R Eye Research LLC

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.1% STN1013600 ophthalmic solution; 0.1% STN1013600 ophthalmic solution 1 drop BID	Drug: 0.1% STN1013600 ophthalmic solution; 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	Drug: 0.3% STN1013600 ophthalmic solution; 0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months
Placebo Comparator: Placebo (Vehicle) ophthalmic solution; Placebo (Vehicle) ophthalmic solution BID	Drug: Placebo; Placebo ophthalmic solution 1 drop BID for 2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA)	Analysis of Change from Baseline at Month 2 was done using Bayesian Approach Analysis Population.	At Month 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2	Summary of Early Treatment Diabetic Retinopathy Study (ETDRS) Letters and Change from Baseline by Analysis Visit.	Month 2
Percentage of Participants Who Improved 1/2/3-lines or More in Study Eye and Binocular Distance Corrected Near Visual Acuity (DCNVA) at Month 2	The response rate is the percentage of participants that achieved the specified gain in Distance Corrected Intermediate Visual Acuity (DCIVA) without losing more than 5 ETDRS (Early Treatment Diabetic Retinopathy Study) letters in Best Corrected Distance Visual Acuity (BCDVA)	Month 2
Mean Change From Baseline in Quality of Life Assessed With Near Activity Visual Questionnaire (NAVQ) at Month 2	Analysis of change from baseline in Rasch Score was done using Mixed-Effects Model for Repeated Measures (MMRM). Least Square Means were obtained by fitting a MMRM model to the NAVQ values. The summated NAVQ score from initial 10 questions ranged from 0 to 30, where higher score indicates more difficulty with near tasks. The summated NAVQ score is converted to Rasch score which ranged from 0 to 100, with higher values indicating more difficulty with near tasks.	Month 2
Subject Treatment Satisfaction as Assessed by Patient Global Rating of Treatment	The response rate is the percent of participants that responded with "Satisfactory" or "Very Satisfactory" when asked to rate the overall satisfaction with the treatment.	Month 2

Collaborators and Investigators

• Sponsor: Santen Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 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): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Santen, Presbyopia, Eye
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Ophthalmic Solutions; Pharmaceutical Solutions
• 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