Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis

Study Overview
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Brief Summary
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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.

Official Title
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Double-masked, Comparison Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3, Confirmatory Study -

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: DE-114 ophthalmic solution
* Drug: Placebo ophthalmic solution
* Drug: Olopatadine Hydrochloride 0.1% Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: DE-114 ophthalmic solution<br> <br> * Other names: Epinastine ophthalmic solution;|
| Placebo Comparator: 2<br> | Drug: Placebo ophthalmic solution<br> <br> |
| Active Comparator: 3<br> | Drug: Olopatadine Hydrochloride 0.1% Ophthalmic Solution<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 . | Visit 5 (3, 5, and 10 minutes post-CAC) | 
| 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 . | Visit 5 (5, 10, and 20 minutes post-CAC) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 . | Visit 7 (3, 5, and 10 minutes post-CAC) | 
| 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 . | Visit 7 (5, 10, and 20 minutes post-CAC) |