Dry Eye
Conditions
Brief summary
To investigate that the efficacy of 3% DE-089 ophthalmic solution (one drop at a time, 6 times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate ophthalmic solution (0.1% HA) (one drop at a time, 6 times daily, 4 weeks topical administration), is at least non-inferior in the change in fluorescein staining score, and is superior in the change in Rose bengal score, in a multicenter, double-masked, parallel-group comparison study. Safety profile will likewise be compared.
Interventions
DRUG3% DE-089 ophthalmic solution
Sponsors
Santen Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Inclusion criteria
* Those who show: * Keratoconjunctival disorder confirmed with vital dye staining * Abnormal Schirmer score results
Exclusion criteria
* Eye disease that needs therapy other than that for dry eye * Those who need to wear contact lenses during the clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Fluorescein Staining Score From Baseline | Baseline and 4-week (discontinued (LOCF)) | Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better. The degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area. |
| Mean Change in Rose Bengal Staining Score From Baseline | Baseline and 4-week (discontinued (LOCF)) | Rose bengal staining were scored according to the protocol by Shimmura et al. The ocular surface was divided into 5 zones: nasal and temporal conjunctival, and upper, middle, and lower corneal areas. A staining score between 0 and 3 points was used in each zone, with the minimum and maximum total staining scores ranging between 0 and 15 points.0 is better. The degree of staining with Rose bengal dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area. |
Countries
Japan
Participant flow
Pre-assignment details
Informed consent was obtained from 332 patients, of whom 287 were randomized and prescribed the study drug.
Participants by arm
| Arm | Count |
|---|---|
| 3% DE-089 3% DE-089 ophthalmic solution | 144 |
| 0.1% HA 0.1% sodium hyaluronate ophthalmic solution | 143 |
| Total | 287 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Fear of adverse events | 0 | 1 |
| Overall Study | Lack of Efficacy | 0 | 2 |
Baseline characteristics
| Characteristic | 3% DE-089 | 0.1% HA | Total |
|---|---|---|---|
| Age, Continuous | 55.3 years STANDARD_DEVIATION 17.1 | 57.0 years STANDARD_DEVIATION 16.8 | 56.1 years STANDARD_DEVIATION 16.9 |
| Sex: Female, Male Female | 120 Participants | 125 Participants | 245 Participants |
| Sex: Female, Male Male | 24 Participants | 18 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 144 | 1 / 143 |
| serious Total, serious adverse events | 0 / 144 | 1 / 143 |
Outcome results
Primary
Mean Change in Fluorescein Staining Score From Baseline
Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better. The degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area.
Time frame: Baseline and 4-week (discontinued (LOCF))
Population: Efficacy analysis was performed full analysis set (FAS). In 0.1% sodium hyaluronate ophthalmic solution group, 1 subject was excluded from analysis because there was no available efficacy data in fluorescein staining.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3% DE-089 | Mean Change in Fluorescein Staining Score From Baseline | -2.12 points | Standard Deviation 1.66 |
| 0.1% HA | Mean Change in Fluorescein Staining Score From Baseline | -2.08 points | Standard Deviation 1.52 |
95% CI: [-0.405, 0.338]l
Primary
Mean Change in Rose Bengal Staining Score From Baseline
Rose bengal staining were scored according to the protocol by Shimmura et al. The ocular surface was divided into 5 zones: nasal and temporal conjunctival, and upper, middle, and lower corneal areas. A staining score between 0 and 3 points was used in each zone, with the minimum and maximum total staining scores ranging between 0 and 15 points.0 is better. The degree of staining with Rose bengal dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area.
Time frame: Baseline and 4-week (discontinued (LOCF))
Population: Efficacy analysis was performed full analysis set (FAS). In 0.1% sodium hyaluronate ophthalmic solution group, 2 subjects were excluded from analysis because there was no available efficacy data in rose bengal staining.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3% DE-089 | Mean Change in Rose Bengal Staining Score From Baseline | -3.06 points | Standard Deviation 2.27 |
| 0.1% HA | Mean Change in Rose Bengal Staining Score From Baseline | -2.38 points | Standard Deviation 2.08 |
p-value: 0.0195% CI: [-1.18, -0.67]t-test, 2 sided