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

Sponsor

Santen Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05665387

Collaborator

(none)

Enrollment

Locations

Arms

7.3

Anticipated Duration (Months)

37.5

Patients Per Site

5.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Drug: 0.1% STN1013600 ophthalmic solution Drug: 0.3% STN1013600 ophthalmic solution Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 21, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Mean change from baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA) [at Month 2]

Secondary Outcome Measures

Mean change from baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at all visits [at Day 7, Day 14, Month 1, Month 2 and Month 3]
Proportion of subjects who improve 1/2/3-lines or more in Study Eye and Binocular Distance Corrected Near Visual Acuity (DCNVA) [at Day 7, Day 14, Month 1, Month 2 and Month 3]
Mean change from baseline in quality of life assessed with Near Activity Visual Questionnaire (NAVQ) [Month 2 and Month 3]
Subject treatment satisfaction as assessed by Patient Global Rating of Treatment [Month 2]

Eligibility Criteria

Criteria

Ages Eligible for Study:

47 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Global Research Management Inc	Glendale	California	United States	91204
2	Total Eye Care PA	Memphis	Tennessee	United States	38119

Sponsors and Collaborators

Santen Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Santen Inc.

ClinicalTrials.gov Identifier:

NCT05665387

Other Study ID Numbers:

101360002IN

First Posted:

Dec 27, 2022

Last Update Posted:

Jan 17, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Santen Inc.

Santen, Presbyopia, Eye

Additional relevant MeSH terms:

Presbyopia

Pharmaceutical Solutions

Ophthalmic Solutions

Study Results

No Results Posted as of Jan 17, 2023