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

NCT05665387 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 101360002IN
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 12

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.

Conditions

Presbyopia

Keywords

Santen, Presbyopia, Eye

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2

  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

  Month 2

• Mean Change From Baseline in Quality of Life Assessed With Near Activity Visual Questionnaire (NAVQ) at Month 2

  Month 2

• Subject Treatment Satisfaction as Assessed by Patient Global Rating of Treatment

  Month 2

Study Arms (3)

0.1% STN1013600 ophthalmic solution

EXPERIMENTAL

0.1% STN1013600 ophthalmic solution 1 drop BID

Drug: 0.1% STN1013600 ophthalmic solution

0.3% STN1013600 ophthalmic solution

EXPERIMENTAL

0.3% STN1013600 ophthalmic solution 1 drop BID

Drug: 0.3% STN1013600 ophthalmic solution

Placebo (Vehicle) ophthalmic solution

PLACEBO COMPARATOR

Placebo (Vehicle) ophthalmic solution BID

Drug: Placebo

Interventions

0.1% STN1013600 ophthalmic solution DRUG

0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months

0.1% STN1013600 ophthalmic solution

0.3% STN1013600 ophthalmic solution DRUG

0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months

0.3% STN1013600 ophthalmic solution

Placebo DRUG

Placebo ophthalmic solution 1 drop BID for 2 months

Placebo (Vehicle) ophthalmic solution

Eligibility Criteria

• Age: 47 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Santen Inc.: lead

Study Sites (12)

Global Research Management Inc

Glendale, California, 91204, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Clayton Eye Clinical Research, LLC

Morrow, Georgia, 30260, United States

Location

Comprehensive Eye Care, Ltd

Washington, Missouri, 63090, United States

Location

Rochester Ophthalmological Group, P.C.

Rochester, New York, 14618, United States

Location

Asheville Eye Associates

Asheville, North Carolina, 28803, United States

Location

Scott Christie and Associates PC

Cranberry Township, Pennsylvania, 16066, United States

Location

Vance Thompson Vision Clinic

Sioux Falls, South Dakota, 57108, United States

Location

University Eye Specialists

Maryville, Tennessee, 37803, United States

Location

Total Eye Care PA

Memphis, Tennessee, 38119, United States

Location

The Cataract and Glaucoma Center

El Paso, Texas, 79902, United States

Location

R and R Eye Research LLC

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Director of R&D Quality Management
• Organization: Santen Inc

evelyn.chikere@santen.com

15106851794

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: December 27, 2022
• Study Start: December 22, 2022
• Primary Completion: July 27, 2023
• Study Completion: July 27, 2023
• Last Updated: May 29, 2024
• Results First Posted: May 29, 2024

Record last verified: 2024-05

Locations

US (12)