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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.1% STN1013600 ophthalmic solution | Experimental | 0.1% STN1013600 ophthalmic solution 1 drop BID |
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| 0.3% STN1013600 ophthalmic solution | Experimental | 0.3% STN1013600 ophthalmic solution 1 drop BID |
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| Placebo (Vehicle) ophthalmic solution | Placebo Comparator | Placebo (Vehicle) ophthalmic solution BID |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.1% STN1013600 ophthalmic solution | Drug | 0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Month 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Research Management Inc | Glendale | California | 91204 | United States | ||
| Eye Research Foundation |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.3% STN1013600 Ophthalmic Solution | 0.3% STN1013600 ophthalmic solution 1 drop BID 0.3% STN1013600 ophthalmic solution: 0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months |
| FG001 | 0.1% STN1013600 Ophthalmic Solution |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 23, 2022 | Mar 20, 2024 |
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| 0.3% STN1013600 ophthalmic solution | Drug | 0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months |
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| Placebo | Drug | Placebo ophthalmic solution 1 drop BID for 2 months |
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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) |
| 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. | 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. | Month 2 |
| Newport Beach |
| California |
| 92663 |
| United States |
| Clayton Eye Clinical Research, LLC | Morrow | Georgia | 30260 | United States |
| Comprehensive Eye Care, Ltd | Washington | Missouri | 63090 | United States |
| Rochester Ophthalmological Group, P.C. | Rochester | New York | 14618 | United States |
| Asheville Eye Associates | Asheville | North Carolina | 28803 | United States |
| Scott Christie and Associates PC | Cranberry Township | Pennsylvania | 16066 | United States |
| Vance Thompson Vision Clinic | Sioux Falls | South Dakota | 57108 | United States |
| University Eye Specialists | Maryville | Tennessee | 37803 | United States |
| Total Eye Care PA | Memphis | Tennessee | 38119 | United States |
| The Cataract and Glaucoma Center | El Paso | Texas | 79902 | United States |
| R and R Eye Research LLC | San Antonio | Texas | 78229 | United States |
0.1% STN1013600 ophthalmic solution 1 drop BID
0.1% STN1013600 ophthalmic solution: 0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months
| FG002 | Placebo (Vehicle) Ophthalmic Solution | Placebo (Vehicle) ophthalmic solution BID Placebo: Placebo ophthalmic solution 1 drop BID for 2 months |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.3% STN1013600 Ophthalmic Solution | 0.3% STN1013600 ophthalmic solution 1 drop BID 0.3% STN1013600 ophthalmic solution: 0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months |
| BG001 | 0.1% STN1013600 Ophthalmic Solution | 0.1% STN1013600 ophthalmic solution 1 drop BID 0.1% STN1013600 ophthalmic solution: 0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months |
| BG002 | Placebo (Vehicle) Ophthalmic Solution | Placebo (Vehicle) ophthalmic solution BID Placebo: Placebo ophthalmic solution 1 drop BID for 2 months |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set (FAS) included all randomized subjects. The number analyzed are participants evaluable for the outcome measure at Month 2. | Posted | Mean | Standard Error | EDTRS letters | At Month 2 |
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| Secondary | 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. | Full Analysis Set (observed cases only). | Posted | Mean | Standard Deviation | EDTRS letters | Month 2 |
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| Secondary | 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) | Full Analysis Set (observed cases only). | Posted | Count of Participants | Participants | Month 2 |
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| Secondary | 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. | Full Analysis Set (observed cases only). | Posted | Least Squares Mean | Standard Error | score on a scale | Month 2 |
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| Secondary | 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. | Full Analysis Set (Observed cases only) | Posted | Count of Participants | Participants | Month 2 |
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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.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.3% STN1013600 Ophthalmic Solution | 0.3% STN1013600 ophthalmic solution 1 drop BID 0.3% STN1013600 ophthalmic solution: 0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months | 0 | 30 | 0 | 30 | 7 | 30 |
| EG001 | 0.1% STN1013600 Ophthalmic Solution | 0.1% STN1013600 ophthalmic solution 1 drop BID 0.1% STN1013600 ophthalmic solution: 0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months | 0 | 33 | 0 | 33 | 9 | 33 |
| EG002 | Placebo (Vehicle) Ophthalmic Solution | Placebo (Vehicle) ophthalmic solution BID Placebo: Placebo ophthalmic solution 1 drop BID for 2 months | 0 | 16 | 0 | 16 | 2 | 16 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Foreign body sensation in eyes | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Retinal pigment epitheliopathy | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Instillation site irritation | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Instillation site discomfort | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Liver function test increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of R&D Quality Management | Santen Inc | 15106851794 | evelyn.chikere@santen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 8, 2023 | Mar 20, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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