Keratoconjunctival Epithelial Disorder
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of OPC-12759 ophthalmic suspension for patients with keratoconjunctival epithelial disorder compared with sodium hyaluronate. Also, safety of OPC-12759 is to be assessed.
Interventions
OPC-12759 ophthalmic suspension 2%
DRUGSodium hyaluronate ophthalmic solution
Sodium hyaluronate ophthalmic solution 0.1%
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of superficial punctate keratopathy, corneal erosion or persistent epithelial defect 2. Fluorescein corneal staining score of 3 or higher
Exclusion criteria
1. Active ocular infection 2. Vernal keratoconjunctivitis 3. Recurrent corneal erosion 4. Physical irritation of eyelashes or relaxed bulbar conjunctiva to cornea or conjunctiva 5. Subjects who cannot discontinue or anticipate use of eye drops except for limited concomitant ones during the study. Soft-santear is allowed during the screening period. 6. Anticipated use of contact lens during the study. 7. Insertion of punctal plug or fall out of punctal plug within 3 months 8. Subjects who are judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease. 9. Receipt of any investigational product within 4 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Keratoconjunctival Staining Score From Baseline | Basekine, 4 weeks | Keratoconjunctival staining indicates the damage to the corneal and conjunctival epithelium. The cornea and conjunctiva were divided into 3 and 2 fractions, respectively, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. The change from baseline at the end of instillation (LOCF) in the keratoconjunctival staining score were compared between the 2% rebamipide group and the 0.1% sodium hyaluronate group using a t-test. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OPC-12759 Ophthalmic Suspension OPC-12759 ophthalmic suspension 2% | 51 |
| Sodium Hyaluronate Ophthalmic Solution Sodium hyaluronate ophthalmic solution 0.1% | 51 |
| Total | 102 |
Baseline characteristics
| Characteristic | OPC-12759 Ophthalmic Suspension | Sodium Hyaluronate Ophthalmic Solution | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 20 Participants | 24 Participants | 44 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 27 Participants | 58 Participants |
| Age, Continuous | 54.9 years STANDARD_DEVIATION 17.9 | 54.5 years STANDARD_DEVIATION 20.9 | 54.7 years STANDARD_DEVIATION 19.3 |
| Region of Enrollment Japan | 51 participants | 51 participants | 102 participants |
| Sex: Female, Male Female | 41 Participants | 34 Participants | 75 Participants |
| Sex: Female, Male Male | 10 Participants | 17 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 51 | 12 / 51 |
| serious Total, serious adverse events | 1 / 51 | 0 / 51 |
Outcome results
Primary
Change in the Keratoconjunctival Staining Score From Baseline
Keratoconjunctival staining indicates the damage to the corneal and conjunctival epithelium. The cornea and conjunctiva were divided into 3 and 2 fractions, respectively, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. The change from baseline at the end of instillation (LOCF) in the keratoconjunctival staining score were compared between the 2% rebamipide group and the 0.1% sodium hyaluronate group using a t-test.
Time frame: Basekine, 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPC-12759 Ophthalmic Suspension | Change in the Keratoconjunctival Staining Score From Baseline | -3.4 scores on a scale | Standard Deviation 2.7 |
| Sodium Hyaluronate Ophthalmic Solution | Change in the Keratoconjunctival Staining Score From Baseline | -3.1 scores on a scale | Standard Deviation 2.4 |
p-value: 0.576t-test, 2 sided