Dry Eye Syndromes
Conditions
Brief summary
The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks in dry eye patients
Interventions
Instillation,4times/day,for 52weeks
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Out patient; 2. Ocular discomfort severity is moderate to severe; 3. Corneal-conjunctival damage is moderate to severe; 4. Unanesthetized Schirmer's test score of 5mm/5minutes or less,or tear breakup time is 5 seconds or less; 5. Best corrected visual acuity of 0.2 or better in both eyes.
Exclusion criteria
1. Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis scicca; 2. Ocular hypertention patient or glaucoma patient with ophthalmic solution; 3. Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study; 4. Anticipated use of contact lens during the study; 5. Patient with punctal plug; 6. Any history of ocular surgery within 12 months; 7. Female patients who are pregnant, possibly pregnant or breast feeding; 8. Known hypersensitivity to any component of the study drug or procedual medications; 9. Receipt of any investigational product within 4 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score | Baseline, Week2, Week4, Week28, Week52 | FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score | Baseline, Week2, Week4, Week28, Week52 | LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-18). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test). |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 2% Rebamipide Group 2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks | 154 |
| Total | 154 |
Baseline characteristics
| Characteristic | 2% Rebamipide Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 64 Participants |
| Age, Categorical Between 18 and 65 years | 90 Participants |
| Age, Continuous | 59.3 years STANDARD_DEVIATION 14.7 |
| Region of Enrollment Japan | 154 participants |
| Sex: Female, Male Female | 139 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 125 / 154 |
| serious Total, serious adverse events | 6 / 154 |
Outcome results
Primary
Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score
FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test).
Time frame: Baseline, Week2, Week4, Week28, Week52
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2% Rebamipide Group | Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score | CFB at Week2 (n=154) | -2.2 FCS score | Standard Deviation 2.3 |
| 2% Rebamipide Group | Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score | CFB at Week4 (n=149) | -2.7 FCS score | Standard Deviation 2.4 |
| 2% Rebamipide Group | Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score | CFB at Week28 (n=135) | -4.1 FCS score | Standard Deviation 2.8 |
| 2% Rebamipide Group | Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score | CFB at Week52 (n=127) | -4.6 FCS score | Standard Deviation 2.6 |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
Other Pre-specified
Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score
LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-18). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test).
Time frame: Baseline, Week2, Week4, Week28, Week52
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2% Rebamipide Group | Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score | CFB at Week2 (n=154) | -2.6 LGCS score | Standard Deviation 3 |
| 2% Rebamipide Group | Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score | CFB at Week4 (n=149) | -3.3 LGCS score | Standard Deviation 3.2 |
| 2% Rebamipide Group | Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score | CFB at Week28 (n=135) | -5.7 LGCS score | Standard Deviation 4 |
| 2% Rebamipide Group | Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score | CFB at Week52 (n=127) | -6.0 LGCS score | Standard Deviation 3.7 |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided