Allergic Conjunctivitis
Conditions
Brief summary
Safety and efficacy of DE-114 ophthalmic solution will be evaluated in patients with allergic conjunctivitis, in an open-label, multicenter study.
Interventions
Sponsors
Santen Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Inclusion criteria
* Provided signed, written informed consent. * Has a positive result from a Type I allergy test. * If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.
Exclusion criteria
* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception. * Presence of any abnormality or significant illness that could be expected to interfere with the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ocular Itching Score by Visit | From baseline to 8-week | Change from baseline in the average of Ocular itching score over the past 3 days. Ocular itching was assessed by the subject and graded on a 5 points scale of 0-4 (0=no itching, 4=incapacitating itch). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Palpebral Hyperemia Score by Visit | From baseline to 8-week | Change from baseline of palpebral hyperemia score. Palpebral hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined. |
| Change in Bulbar Conjunctiva Hyperemia Score by Visit | From baseline to 8-week | Change from baseline of bulbar conjunctiva hyperemia score. Bulbar conjunctiva hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DE-114 Ophthalmic Solution DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study. | 130 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | DE-114 Ophthalmic Solution |
|---|---|
| Age, Continuous | 40.2 years STANDARD_DEVIATION 13 |
| Sex: Female, Male Female | 69 Participants |
| Sex: Female, Male Male | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 130 |
| serious Total, serious adverse events | 0 / 130 |
Outcome results
Primary
Change in Ocular Itching Score by Visit
Change from baseline in the average of Ocular itching score over the past 3 days. Ocular itching was assessed by the subject and graded on a 5 points scale of 0-4 (0=no itching, 4=incapacitating itch). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined.
Time frame: From baseline to 8-week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DE-114 Ophthalmic Solution | Change in Ocular Itching Score by Visit | Change in baseline to visit 2 (Day7) | -0.6 score | Standard Error 0.1 |
| DE-114 Ophthalmic Solution | Change in Ocular Itching Score by Visit | Change in baseline to visit 3 (Day14) | -0.9 score | Standard Error 0.1 |
| DE-114 Ophthalmic Solution | Change in Ocular Itching Score by Visit | Change in baseline to visit 4 (Day28) | -1.3 score | Standard Error 0.1 |
| DE-114 Ophthalmic Solution | Change in Ocular Itching Score by Visit | Change in baseline to visit 5 (Day42) | -1.7 score | Standard Error 0.1 |
| DE-114 Ophthalmic Solution | Change in Ocular Itching Score by Visit | Change in baseline to visit 6 (Day56) | -2.2 score | Standard Error 0.1 |
Other Pre-specified
Change in Bulbar Conjunctiva Hyperemia Score by Visit
Change from baseline of bulbar conjunctiva hyperemia score. Bulbar conjunctiva hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined.
Time frame: From baseline to 8-week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DE-114 Ophthalmic Solution | Change in Bulbar Conjunctiva Hyperemia Score by Visit | Change in baseline to visit 2 (Day7) | -0.4 score | Standard Error 0.1 |
| DE-114 Ophthalmic Solution | Change in Bulbar Conjunctiva Hyperemia Score by Visit | Change in baseline to visit 3 (Day14) | -0.4 score | Standard Error 0.1 |
| DE-114 Ophthalmic Solution | Change in Bulbar Conjunctiva Hyperemia Score by Visit | Change in baseline to visit 4 (Day28) | -0.6 score | Standard Error 0.1 |
| DE-114 Ophthalmic Solution | Change in Bulbar Conjunctiva Hyperemia Score by Visit | Change in baseline to visit 5 (Day42) | -0.7 score | Standard Error 0.1 |
| DE-114 Ophthalmic Solution | Change in Bulbar Conjunctiva Hyperemia Score by Visit | Change in baseline to visit 6 (Day56) | -0.8 score | Standard Error 0.1 |
Other Pre-specified
Change in Palpebral Hyperemia Score by Visit
Change from baseline of palpebral hyperemia score. Palpebral hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined.
Time frame: From baseline to 8-week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DE-114 Ophthalmic Solution | Change in Palpebral Hyperemia Score by Visit | Change in baseline to visit 2 (Day7) | -0.3 score | Standard Error 0 |
| DE-114 Ophthalmic Solution | Change in Palpebral Hyperemia Score by Visit | Change in baseline to visit 3 (Day14) | -0.3 score | Standard Error 0.1 |
| DE-114 Ophthalmic Solution | Change in Palpebral Hyperemia Score by Visit | Change in baseline to visit 4 (Day28) | -0.6 score | Standard Error 0.1 |
| DE-114 Ophthalmic Solution | Change in Palpebral Hyperemia Score by Visit | Change in baseline to visit 5 (Day42) | -0.7 score | Standard Error 0.1 |
| DE-114 Ophthalmic Solution | Change in Palpebral Hyperemia Score by Visit | Change in baseline to visit 6 (Day56) | -1.0 score | Standard Error 0.1 |