Dry Eye Syndromes
Conditions
Brief summary
The purpose of this study is to verify whether OPC-12759 ophthalmic suspension is effective compared with active control in dry eye patients.
Interventions
OPC-12759 Ophthalmic suspension 2%
DRUGHyalein Mini Ophthalmic solution
Hyalein Mini Ophthalmic solution 0.1%
Sponsors
Otsuka 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
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Out patient 2. Subjective complaint of dry eye that has been present for minimum 20 months 3. Ocular discomfort severity is moderate to severe 4. Corneal - conjunctival damage is moderate to severe 5. Unanesthetized Schirmer's test score of 5mm/5minutes or less 6. 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 sicca 2. Ocular hypertension 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 procedural medications 9. Receipt of any investigational product within 4 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fluorescein Corneal Staining (FCS) Score From Baseline | Baseline, Weeks4 | 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. Noninferiority for change from baseline in the FCS score (LOCF) was determined by comparing the noninferiority margin (0.4) with the upper limit of the 95% confidence interval (CI) of the difference between the 2 treatment groups |
| Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline | Baseline, Weeks4 | 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 sdore from 0 to 3, and the total score was calculated (0-18). 0 is better. Superiority was verified by comparing t-test results for change from baseline in the LGCS score (LOCF) between 2 treatment groups. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rebamipide Instillation,4 times/day for 4 weeks
OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2% | 93 |
| Hyaluronate Instillation,6 times/day for 4 weeks
Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1% | 95 |
| Total | 188 |
Baseline characteristics
| Characteristic | Hyaluronate | Rebamipide | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 36 Participants | 38 Participants | 74 Participants |
| Age, Categorical Between 18 and 65 years | 59 Participants | 55 Participants | 114 Participants |
| Age Continuous | 55.2 years STANDARD_DEVIATION 16.9 | 58.0 years STANDARD_DEVIATION 17.7 | 56.6 years STANDARD_DEVIATION 17.4 |
| Region of Enrollment Japan | 95 participants | 93 participants | 188 participants |
| Sex: Female, Male Female | 80 Participants | 83 Participants | 163 Participants |
| Sex: Female, Male Male | 15 Participants | 10 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 27 / 93 | 19 / 95 |
| serious Total, serious adverse events | 0 / 93 | 0 / 95 |
Outcome results
Primary
Change in Fluorescein Corneal Staining (FCS) Score From Baseline
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. Noninferiority for change from baseline in the FCS score (LOCF) was determined by comparing the noninferiority margin (0.4) with the upper limit of the 95% confidence interval (CI) of the difference between the 2 treatment groups
Time frame: Baseline, Weeks4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rebamipide | Change in Fluorescein Corneal Staining (FCS) Score From Baseline | -3.7 units on a scale | Standard Deviation 0.3 |
| Hyaluronate | Change in Fluorescein Corneal Staining (FCS) Score From Baseline | -2.9 units on a scale | Standard Deviation 0.2 |
p-value: <0.0595% CI: [-1.47, -0.24]t-test, 2 sided
Primary
Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline
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 sdore from 0 to 3, and the total score was calculated (0-18). 0 is better. Superiority was verified by comparing t-test results for change from baseline in the LGCS score (LOCF) between 2 treatment groups.
Time frame: Baseline, Weeks4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rebamipide | Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline | -4.5 units on a scale | Standard Deviation 3.2 |
| Hyaluronate | Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline | -2.4 units on a scale | Standard Deviation 2.5 |
p-value: <0.05t-test, 2 sided