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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Presbyopia

Intervention / Treatment
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* Drug: 0.1% STN1013600 ophthalmic solution
* Drug: 0.3% STN1013600 ophthalmic solution
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 47 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.1% STN1013600 ophthalmic solution<br>0.1% STN1013600 ophthalmic solution 1 drop BID | Drug: 0.1% STN1013600 ophthalmic solution<br>* 0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months<br>|
| Experimental: 0.3% STN1013600 ophthalmic solution<br>0.3% STN1013600 ophthalmic solution 1 drop BID | Drug: 0.3% STN1013600 ophthalmic solution<br>* 0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months<br>|
| Placebo Comparator: Placebo (Vehicle) ophthalmic solution<br>Placebo (Vehicle) ophthalmic solution BID | Drug: Placebo<br>* Placebo ophthalmic solution 1 drop BID for 2 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA) |  | 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Santen, Presbyopia, Eye