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NCT Number: NCT05665387

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

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.

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

47 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Global Research Management Inc, Glendale, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

0.1% STN1013600 ophthalmic solution

Drug

0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months

0.3% STN1013600 ophthalmic solution

Drug

0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months

Placebo

Drug

Placebo ophthalmic solution 1 drop BID for 2 months

Primary outcomes

  1. Mean Change From Baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA)

    Time frame: At Month 2

    Analysis of Change from Baseline at Month 2 was done using Bayesian Approach Analysis Population.

Secondary outcomes

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

    Time frame: Month 2

    Summary of Early Treatment Diabetic Retinopathy Study (ETDRS) Letters and Change from Baseline by Analysis Visit.

  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

    Time frame: 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)

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

    Time frame: 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.

  4. Subject Treatment Satisfaction as Assessed by Patient Global Rating of Treatment

    Time frame: Month 2

    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.

Sponsors and collaborators

Lead sponsor

Santen Inc.

Industry

Registry information

Official study 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

Acronym: OPSIS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 27, 2022
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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