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

Santen Inc.79 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Presbyopia

Interventions

0.1% STN1013600 ophthalmic solutionDRUG

0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months

0.3% STN1013600 ophthalmic solutionDRUG

0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months

PlaceboDRUG

Placebo ophthalmic solution 1 drop BID for 2 months

Eligibility

Sex: ALLMin age: 47 YearsMax age: 55 Years

Medical Language ↔ Plain English

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).

Locations (12)

Global Research Management Inc

Glendale, California, United States

Eye Research Foundation

Newport Beach, California, United States

Clayton Eye Clinical Research, LLC

Morrow, Georgia, United States

Outcomes

Primary Outcomes

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.

Time frame: At Month 2

Secondary Outcomes

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.

Time frame: 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

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)

Time frame: Month 2

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.

Time frame: Month 2

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.

Data from ClinicalTrials.gov

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