Presbyopia
Conditions
Keywords
Santen, Presbyopia, Eye
Brief summary
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.
Interventions
DRUG0.1% STN1013600 ophthalmic solution
0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months
DRUG0.3% STN1013600 ophthalmic solution
0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months
DRUGPlacebo
Placebo ophthalmic solution 1 drop BID for 2 months
Sponsors
Santen Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
47 Years to 55 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| 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 | 33 |
| Placebo (Vehicle) Ophthalmic Solution Placebo (Vehicle) ophthalmic solution BID
Placebo: Placebo ophthalmic solution 1 drop BID for 2 months | 16 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo (Vehicle) Ophthalmic Solution | Total | 0.3% STN1013600 Ophthalmic Solution | 0.1% STN1013600 Ophthalmic Solution |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 79 Participants | 30 Participants | 33 Participants |
| Age, Continuous | 51.4 years STANDARD_DEVIATION 1.78 | 51.4 years STANDARD_DEVIATION 2.25 | 51.6 years STANDARD_DEVIATION 2.2 | 51.1 years STANDARD_DEVIATION 2.51 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 11 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 64 Participants | 27 Participants | 23 Participants |
| Region of Enrollment United States | 16 participants | 79 participants | 30 participants | 33 participants |
| Sex: Female, Male Female | 11 Participants | 50 Participants | 17 Participants | 22 Participants |
| Sex: Female, Male Male | 5 Participants | 29 Participants | 13 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 33 | 0 / 16 |
| other Total, other adverse events | 7 / 30 | 9 / 33 | 2 / 16 |
| serious Total, serious adverse events | 0 / 30 | 0 / 33 | 0 / 16 |
Outcome results
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.
Time frame: At Month 2
Population: Full Analysis Set (FAS) included all randomized subjects. The number analyzed are participants evaluable for the outcome measure at Month 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.3% STN1013600 Ophthalmic Solution | Mean Change From Baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA) | 4.1 EDTRS letters | Standard Error 1.24 |
| 0.1% STN1013600 Ophthalmic Solution | Mean Change From Baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA) | 4.3 EDTRS letters | Standard Error 1.18 |
| Placebo (Vehicle) Ophthalmic Solution | Mean Change From Baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA) | 4.4 EDTRS letters | Standard Error 1.13 |
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.
Time frame: Month 2
Population: Full Analysis Set (observed cases only).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 0.3% STN1013600 Ophthalmic Solution | Mean Change From Baseline in Quality of Life Assessed With Near Activity Visual Questionnaire (NAVQ) at Month 2 | -7.493 score on a scale | Standard Error 2.1803 |
| 0.1% STN1013600 Ophthalmic Solution | Mean Change From Baseline in Quality of Life Assessed With Near Activity Visual Questionnaire (NAVQ) at Month 2 | -8.140 score on a scale | Standard Error 2.0939 |
| Placebo (Vehicle) Ophthalmic Solution | Mean Change From Baseline in Quality of Life Assessed With Near Activity Visual Questionnaire (NAVQ) at Month 2 | -10.510 score on a scale | Standard Error 3.1447 |
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.
Time frame: Month 2
Population: Full Analysis Set (observed cases only).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.3% STN1013600 Ophthalmic Solution | Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2 | Month 2 Observed | 66.4 EDTRS letters | Standard Deviation 6.69 |
| 0.3% STN1013600 Ophthalmic Solution | Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2 | Baseline Observed | 62.2 EDTRS letters | Standard Deviation 6.29 |
| 0.3% STN1013600 Ophthalmic Solution | Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2 | Month 2 Change from Baseline | 4.2 EDTRS letters | Standard Deviation 6.65 |
| 0.1% STN1013600 Ophthalmic Solution | Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2 | Month 2 Observed | 67.9 EDTRS letters | Standard Deviation 8.1 |
| 0.1% STN1013600 Ophthalmic Solution | Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2 | Baseline Observed | 63.5 EDTRS letters | Standard Deviation 4.84 |
| 0.1% STN1013600 Ophthalmic Solution | Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2 | Month 2 Change from Baseline | 4.4 EDTRS letters | Standard Deviation 7.15 |
| Placebo (Vehicle) Ophthalmic Solution | Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2 | Baseline Observed | 63.8 EDTRS letters | Standard Deviation 4.71 |
| Placebo (Vehicle) Ophthalmic Solution | Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2 | Month 2 Change from Baseline | 4.8 EDTRS letters | Standard Deviation 5.88 |
| Placebo (Vehicle) Ophthalmic Solution | Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2 | Month 2 Observed | 68.7 EDTRS letters | Standard Deviation 7.58 |
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)
Time frame: Month 2
Population: Full Analysis Set (observed cases only).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 0.3% STN1013600 Ophthalmic Solution | 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 Having a gain of 10 or more letters in DCIVA without loosing more than 5 letters in BCDVA | 6 Participants |
| 0.3% STN1013600 Ophthalmic Solution | 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 Having a gain of 5 or more letters in DCIVA without loosing more than 5 letters in BCDVA | 13 Participants |
| 0.3% STN1013600 Ophthalmic Solution | 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 Having a gain of 15 or more letters in DCIVA without loosing more than 5 letters in BCDVA | 1 Participants |
| 0.1% STN1013600 Ophthalmic Solution | 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 Having a gain of 10 or more letters in DCIVA without loosing more than 5 letters in BCDVA | 12 Participants |
| 0.1% STN1013600 Ophthalmic Solution | 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 Having a gain of 5 or more letters in DCIVA without loosing more than 5 letters in BCDVA | 17 Participants |
| 0.1% STN1013600 Ophthalmic Solution | 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 Having a gain of 15 or more letters in DCIVA without loosing more than 5 letters in BCDVA | 5 Participants |
| Placebo (Vehicle) Ophthalmic Solution | 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 Having a gain of 5 or more letters in DCIVA without loosing more than 5 letters in BCDVA | 5 Participants |
| Placebo (Vehicle) Ophthalmic Solution | 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 Having a gain of 15 or more letters in DCIVA without loosing more than 5 letters in BCDVA | 0 Participants |
| Placebo (Vehicle) Ophthalmic Solution | 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 Having a gain of 10 or more letters in DCIVA without loosing more than 5 letters in BCDVA | 0 Participants |
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.
Time frame: Month 2
Population: Full Analysis Set (Observed cases only)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0.3% STN1013600 Ophthalmic Solution | Subject Treatment Satisfaction as Assessed by Patient Global Rating of Treatment | 13 Participants |
| 0.1% STN1013600 Ophthalmic Solution | Subject Treatment Satisfaction as Assessed by Patient Global Rating of Treatment | 18 Participants |
| Placebo (Vehicle) Ophthalmic Solution | Subject Treatment Satisfaction as Assessed by Patient Global Rating of Treatment | 9 Participants |