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

Phase 2

Completed

• Conditions: Presbyopia
• Interventions: Drug: 0.1% STN1013600 ophthalmic solution; Drug: 0.3% STN1013600 ophthalmic solution; Drug: Placebo

• Registration Number: NCT05665387
• Lead Sponsor: Santen Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-16
• Study First Submitted QC: 2022-12-16
• Study Start: 2022-12-22
• Study First Posted: 2022-12-27
• Primary Completion: 2023-07-27
• Study Completion: 2023-07-27
• Results First Submitted: 2024-03-20
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-02
• Last Update Submitted: 2024-05-02
• Results First Posted: 2024-05-29
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.1% STN1013600 ophthalmic solution	0.1% STN1013600 ophthalmic solution	0.1% STN1013600 ophthalmic solution 1 drop BID
0.3% STN1013600 ophthalmic solution	0.3% STN1013600 ophthalmic solution	0.3% STN1013600 ophthalmic solution 1 drop BID
Placebo (Vehicle) ophthalmic solution	Placebo	Placebo (Vehicle) ophthalmic solution BID

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2	Month 2	Summary of Early Treatment Diabetic Retinopathy Study (ETDRS) Letters and Change from Baseline by Analysis Visit.
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	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)
Mean Change From Baseline in Quality of Life Assessed With Near Activity Visual Questionnaire (NAVQ) at Month 2	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.
Subject Treatment Satisfaction as Assessed by Patient Global Rating of Treatment	Month 2	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.

Trial Locations

Locations (12)

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States

Asheville Eye Associates; 🇺🇸 Asheville, North Carolina, United States

R and R Eye Research LLC; 🇺🇸 San Antonio, Texas, United States

The Cataract and Glaucoma Center; 🇺🇸 El Paso, Texas, United States

Global Research Management Inc; 🇺🇸 Glendale, 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

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

Scott Christie and Associates PC; 🇺🇸 Cranberry Township, Pennsylvania, United States