Allergic Conjunctivitis
Conditions
Brief summary
The purpose of the study is to demonstrate safety and efficacy of DE-114 ophthalmic solution compared to its Placebo and Olopatadine hydrochloride 0.1% ophthalmic solution in patients with allergic conjunctivitis.
Interventions
DRUGPlacebo ophthalmic solution
Sponsors
Santen Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Inclusion criteria
* Provided signed, written informed consent. * Has a positive result from an allergen-specific IgE antibody 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 |
|---|---|---|
| Mean Ocular Itching Score Compared to Placebo Period1 | Visit 5 (3, 5, and 10 minutes post-CAC) | A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge and graded on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch. Count unit was defined each eye. The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge . |
| Mean Hyperemia Score Compared to Placebo Period1 | Visit 5 (5, 10, and 20 minutes post-CAC) | A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores. Count unit was defined each eye. The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Ocular Itching Score Compared to Olopatadine Period2 | Visit 7 (3, 5, and 10 minutes post-CAC) | A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch. The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge . |
| Mean Hyperemia Score Compared to Olopatadine Period2 | Visit 7 (5, 10, and 20 minutes post-CAC) | A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores. The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge . |
Countries
Japan
Participant flow
Recruitment details
* Period1 comparison with placebo (Epinastine vs Placebo) * Period2 comparison with olopatadine (Epinastine vs Olopatadine)
Pre-assignment details
All participants completed Period 1 were randomized 1:1 to 2 groups in Period 2.
Participants by arm
| Arm | Count |
|---|---|
| Epinastine / Placebo Period1 Epinastine / Placebo : DE-114 ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits. | 43 |
| Epinastine / Epinastine Period1 Epinastine / Epinastine : DE-114 ophthalmic solution, 1 drop in each eye at designated visits. | 22 |
| Placebo / Placebo Period1 Placebo / Placebo : vehicle of DE-114 ophthalmic solution, 1 drop in each eye at designated visits. | 22 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Epinastine vs Placebo Period1 | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Epinastine / Placebo Period1 | Epinastine / Epinastine Period1 | Placebo / Placebo Period1 | Total |
|---|---|---|---|---|
| Age, Continuous | 39.5 years STANDARD_DEVIATION 11 | 39.0 years STANDARD_DEVIATION 10 | 39.7 years STANDARD_DEVIATION 11.7 | 39.4 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 17 Participants | 11 Participants | 11 Participants | 39 Participants |
| Sex: Female, Male Male | 26 Participants | 11 Participants | 11 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 87 | 0 / 87 | 0 / 43 | 0 / 43 | 0 / 86 |
| serious Total, serious adverse events | 0 / 87 | 0 / 87 | 0 / 43 | 0 / 43 | 0 / 86 |
Outcome results
Primary
Mean Hyperemia Score Compared to Placebo Period1
A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores. Count unit was defined each eye. The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge .
Time frame: Visit 5 (5, 10, and 20 minutes post-CAC)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epinastine (DE-114) Ophthalmic Solution | Mean Hyperemia Score Compared to Placebo Period1 | 2.7 score | Standard Error 0.1 |
| Placebo Ophthalmic Solution | Mean Hyperemia Score Compared to Placebo Period1 | 4.1 score | Standard Error 0.2 |
p-value: <0.00195% CI: [-1.71, -0.92]t-test, 2 sided
Primary
Mean Ocular Itching Score Compared to Placebo Period1
A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge and graded on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch. Count unit was defined each eye. The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge .
Time frame: Visit 5 (3, 5, and 10 minutes post-CAC)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epinastine (DE-114) Ophthalmic Solution | Mean Ocular Itching Score Compared to Placebo Period1 | 0.4 score | Standard Error 0.1 |
| Placebo Ophthalmic Solution | Mean Ocular Itching Score Compared to Placebo Period1 | 1.7 score | Standard Error 0.1 |
p-value: <0.00195% CI: [-1.52, -1.11]t-test, 2 sided
Secondary
Mean Hyperemia Score Compared to Olopatadine Period2
A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores. The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge .
Time frame: Visit 7 (5, 10, and 20 minutes post-CAC)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epinastine (DE-114) Ophthalmic Solution | Mean Hyperemia Score Compared to Olopatadine Period2 | 2.4 score | Standard Error 0.2 |
| Placebo Ophthalmic Solution | Mean Hyperemia Score Compared to Olopatadine Period2 | 2.7 score | Standard Error 0.2 |
| Placebo Ophthalmic Solution | Mean Hyperemia Score Compared to Olopatadine Period2 | 3.7 score | Standard Error 0.1 |
95% CI: [-0.81, 0.22]
Secondary
Mean Ocular Itching Score Compared to Olopatadine Period2
A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch. The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge .
Time frame: Visit 7 (3, 5, and 10 minutes post-CAC)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epinastine (DE-114) Ophthalmic Solution | Mean Ocular Itching Score Compared to Olopatadine Period2 | 0.2 score | Standard Error 0.1 |
| Placebo Ophthalmic Solution | Mean Ocular Itching Score Compared to Olopatadine Period2 | 0.2 score | Standard Error 0.1 |
| Placebo Ophthalmic Solution | Mean Ocular Itching Score Compared to Olopatadine Period2 | 1.5 score | Standard Error 0.1 |
95% CI: [-0.21, 0.08]