Dry Eye
Conditions
Brief summary
Dose response related to efficacy and safety of DE-089 ophthalmic solution are examined in patients with dry eye, using a multicenter, randomized, double-blind, parallel group comparison study, and the optimal concentration is determined.
Interventions
DRUGPlacebo ophthalmic solution
DRUGDE-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. |
Countries
Japan
Participant flow
Pre-assignment details
Excluded (n=34)
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo ophthalmic solution | 94 |
| Low Concentration 1% DE-089 ophthalmic solution | 96 |
| High Concentration 3% DE-089 ophthalmic solution | 96 |
| Total | 286 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 | 4 |
| Overall Study | Lack of Efficacy | 2 | 3 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Low Concentration | High Concentration | Total |
|---|---|---|---|---|
| Age, Continuous | 56.1 years STANDARD_DEVIATION 17.3 | 57.9 years STANDARD_DEVIATION 16.3 | 56.4 years STANDARD_DEVIATION 17.8 | 56.6 years STANDARD_DEVIATION 17.1 |
| Sex: Female, Male Female | 76 Participants | 85 Participants | 77 Participants | 238 Participants |
| Sex: Female, Male Male | 18 Participants | 11 Participants | 19 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 17 / 94 | 14 / 96 | 28 / 96 |
| serious Total, serious adverse events | 0 / 94 | 0 / 96 | 1 / 96 |
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 per protocol set (PPS). Excluded cases were 7 subjects (3 subjects in 3% group, 3 subjects in 1% group, and 1 subject in Placebo group).~The reason of exclusion: used the prohibited concomitant drug, dosing period shortage, number of doses non-compliance, or had no available efficacy data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change in Fluorescein Staining Score From Baseline | -0.95 points | Standard Deviation 1.33 |
| Low Concentration | Mean Change in Fluorescein Staining Score From Baseline | -1.34 points | Standard Deviation 1.43 |
| High Concentration | Mean Change in Fluorescein Staining Score From Baseline | -1.55 points | Standard Deviation 1.3 |
p-value: 0.004maximum contrast method
p-value: 0.006maximum contrast method