Corneal Epithelial Disorders
Conditions
Brief summary
The purpose of this study is to determine whether SJP-0035 ophthalmic solution is effective in promoting corneal epithelial wound healing in conditions associated with corneal epithelial disorders.
Detailed description
There are currently no approved products available anywhere worldwide for the treatment of corneal epithelial disorders that directly affect the epithelia. A Phase 1 study, Study SJP-0035/1-01, was conducted in healthy volunteers to investigate the safety, tolerability, and pharmacokinetic profile of SJP-0035 ophthalmic solution, and to determine the appropriate dose to be evaluated in patients with moderate to severe corneal epithelial disorders. A Phase 2a study, Study SJP-0035/2-01, was conducted in patients with corneal epithelial disorders to evaluate the efficacy and safety of SJP-0035. This Phase 2a study (Study SJP-0035/2-02) is being conducted to evaluate the safety and efficacy of 2 doses of SJP-0035 ophthalmic solution in patients with corneal epithelial disorders. The study will evaluate if SJP-0035 ophthalmic solution is able to promote corneal epithelial wound healing in patients with corneal epithelial disorders using 2 doses of SJP-0035 ophthalmic solution (0.0002% and 0.001%) that are lower than what was used in the previous Phase 2a study (Study SJP-0035/2-01; 0.005%).
Interventions
DRUGHigh Dose SJP-0035 Ophthalmic Solution
0.001% SJP-0035 Ophthalmic Solution
DRUGLow Dose SJP-0035 Ophthalmic Solution
0.0002% SJP-0035 Ophthalmic Solution
0% SJP-0035 Ophthalmic Solution
Sponsors
Senju Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is capable of understanding the written informed consent form (ICF), provides signed and witnessed written ICF, and agrees to comply with protocol requirements, including all required study visits * Is a male or female 18 years of age or older * Has a moderate to severe corneal epithelial disorder in both eyes * Has blurred vision caused by corneal epithelial disorders in both eyes at Screening and Randomization * Is a female of childbearing potential with a negative pregnancy test result at Screening and Randomization and agrees to use effective contraception throughout the study, or is a postmenopausal woman with a negative pregnancy test result at Screening and Randomization
Exclusion criteria
* Has any corneal stromal or endothelial abnormalities including an active bacterial or viral ocular infection, bullous keratopathy, chemical burns, or any trauma to the cornea in either eye at Screening and Randomization * Has any active or chronic allergic, bacterial, or viral infection of ocular adnexa and eye structures in either eye at Screening and Randomization * Has had intraocular surgery (including cataract or vitreous) in either eye within the last 30 days prior to the first dose of study drug * Has had refractive surgery (including ocular surface laser surgery) in either eye within the last 6 months prior to the first dose of study drug * Has used any ocular medication (except mydriatics, stain, and topical anesthesia used for study assessments) in either eye within 14 days prior to the first dose of study drug, or is anticipated to require such medications during the study. * Is a contact lens wearer and cannot discontinue use in both eyes from Screening through EOS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clearing of Corneal Fluorescein Staining at Week 5 at Week 5 | 5 weeks | A patient will be considered a success for clearing of corneal fluorescein staining if their fluorescein staining has disappeared |
Countries
United States
Participant flow
Recruitment details
Patients were recruited at study sites in the USA and were assigned to study drug only if they met all the inclusion criteria and none of the exclusion criteria. Deviations from the inclusion/exclusion criteria were not permitted.
Pre-assignment details
For patients using prohibited concomitant medications within 14 days prior to planned randomization date, a 14 day washout period was required prior to first dose of study drug. Patients who failed initial screening were allowed to rescreen once.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Patients will administer 1 drop of 0% SJP-0035 ophthalmic solution (consisting of the vehicle for the solution) in the affected eye(s) 4 times daily for 4 weeks
Vehicle of SJP-0035 Ophthalmic solution: 0% SJP-0035 Ophthalmic Solution | 42 |
| 0.0002% SJP-0035 Ophthalmic Solution Patients will administer 1 drop of 0.0002% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.
Low Dose SJP-0035 Ophthalmic Solution: 0.0002% SJP-0035 Ophthalmic Solution | 46 |
| 0.001% SJP-0035 Ophthalmic Solution Patients will administer 1 drop of 0.001% SJP-0035 ophthalmic solution in the affected eye(s) 4 times daily for 4 weeks.
High Dose SJP-0035 Ophthalmic Solution: 0.001% SJP-0035 Ophthalmic Solution | 42 |
| Total | 130 |
Baseline characteristics
| Characteristic | Placebo | Total | 0.001% SJP-0035 Ophthalmic Solution | 0.0002% SJP-0035 Ophthalmic Solution |
|---|---|---|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 10.22 | 61.6 years STANDARD_DEVIATION 10.39 | 60.7 years STANDARD_DEVIATION 11.91 | 61.7 years STANDARD_DEVIATION 9.13 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 4 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 8 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 7 Participants | 28 Participants | 9 Participants | 12 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 35 Participants | 102 Participants | 33 Participants | 34 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 35 Participants | 115 Participants | 37 Participants | 43 Participants |
| Region of Enrollment United States | 42 Participants | 130 Participants | 42 Participants | 46 Participants |
| Sex: Female, Male Female | 6 Participants | 23 Participants | 10 Participants | 7 Participants |
| Sex: Female, Male Male | 36 Participants | 107 Participants | 32 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 46 | 0 / 42 |
| other Total, other adverse events | 10 / 42 | 6 / 46 | 15 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 46 | 1 / 42 |
Outcome results
Primary
Number of Participants With Clearing of Corneal Fluorescein Staining at Week 5 at Week 5
A patient will be considered a success for clearing of corneal fluorescein staining if their fluorescein staining has disappeared
Time frame: 5 weeks
Population: Full Analysis Set: All patients randomly assigned to receive double-masked study drug, who received at least 1 dose of study drug in the study eye, and who had at least 1 post-baseline assessment for the primary efficacy endpoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Clearing of Corneal Fluorescein Staining at Week 5 at Week 5 | 5 Participants |
| 0.0002% SJP-0035 Ophthalmic Solution | Number of Participants With Clearing of Corneal Fluorescein Staining at Week 5 at Week 5 | 7 Participants |
| 0.001% SJP-0035 Ophthalmic Solution | Number of Participants With Clearing of Corneal Fluorescein Staining at Week 5 at Week 5 | 12 Participants |