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

• 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

• Mean Change From Baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA) [At Month 2]: Analysis of Change from Baseline at Month 2 was done using Bayesian Approach Analysis Population.

Secondary outcomes

• Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2 [Month 2]: Summary of Early Treatment Diabetic Retinopathy Study (ETDRS) Letters and Change from Baseline by Analysis Visit.
• 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]: 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)
• Mean Change From Baseline in Quality of Life Assessed With Near Activity Visual Questionnaire (NAVQ) at Month 2 [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.
• Subject Treatment Satisfaction as Assessed by Patient Global Rating of Treatment [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.

Sex: All, ages: 47 Years to 55 Years

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).

Participant flow

Outcome results

• Mean Change From Baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA) (Primary), Mean, EDTRS letters: 0.3% STN1013600 Ophthalmic Solution 4.1 +/- 1.24; 0.1% STN1013600 Ophthalmic Solution 4.3 +/- 1.18; Placebo (Vehicle) Ophthalmic Solution 4.4 +/- 1.13
• Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2 (Secondary), Mean, EDTRS letters: 0.3% STN1013600 Ophthalmic Solution 62.2 +/- 6.29; 0.1% STN1013600 Ophthalmic Solution 63.5 +/- 4.84; Placebo (Vehicle) Ophthalmic Solution 63.8 +/- 4.71
• 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 (Secondary), Count of participants, Participants: 0.3% STN1013600 Ophthalmic Solution 13; 0.1% STN1013600 Ophthalmic Solution 17; Placebo (Vehicle) Ophthalmic Solution 5
• Mean Change From Baseline in Quality of Life Assessed With Near Activity Visual Questionnaire (NAVQ) at Month 2 (Secondary), Least squares mean, score on a scale: 0.3% STN1013600 Ophthalmic Solution -7.493 +/- 2.1803; 0.1% STN1013600 Ophthalmic Solution -8.140 +/- 2.0939; Placebo (Vehicle) Ophthalmic Solution -10.510 +/- 3.1447
• Subject Treatment Satisfaction as Assessed by Patient Global Rating of Treatment (Secondary), Count of participants, Participants: 0.3% STN1013600 Ophthalmic Solution 13; 0.1% STN1013600 Ophthalmic Solution 18; Placebo (Vehicle) Ophthalmic Solution 9

Adverse events

Time frame: Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.

Other adverse events by term

• Study Protocol (PDF, 2022-09-23)
• Statistical Analysis Plan (PDF, 2023-08-08)