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

Presbyopia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05665387
• Other study ID #: 101360002IN
• Status: Completed
• Phase: Phase 2
• Start date: December 22, 2022
• Est. completion date: July 27, 2023

Study information

• Verified date: May 2024
• Source: Santen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: July 27, 2023
• Est. primary completion date: July 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 47 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Presbyopia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Asheville Eye Associates	Asheville	North Carolina
United States	Scott Christie and Associates PC	Cranberry Township	Pennsylvania
United States	The Cataract and Glaucoma Center	El Paso	Texas
United States	Global Research Management Inc	Glendale	California
United States	University Eye Specialists	Maryville	Tennessee
United States	Total Eye Care PA	Memphis	Tennessee
United States	Clayton Eye Clinical Research, LLC	Morrow	Georgia
United States	Eye Research Foundation	Newport Beach	California
United States	Rochester Ophthalmological Group, P.C.	Rochester	New York
United States	R and R Eye Research LLC	San Antonio	Texas
United States	Vance Thompson Vision Clinic	Sioux Falls	South Dakota
United States	Comprehensive Eye Care, Ltd	Washington	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Santen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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