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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
| |
| 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DE-114 ophthalmic solution | Drug |
|
| |
| Placebo ophthalmic solution |
| 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) |
| 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 . |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santen study sites | Osaka | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25163405 | Derived | Fujishima H, Ohashi Y, Takamura E. Efficacy of epinastine hydrochloride ophthalmic solution in allergic conjunctivitis by conjunctival cedar pollen allergen challenge. Ann Allergy Asthma Immunol. 2014 Oct;113(4):476-81. doi: 10.1016/j.anai.2014.07.007. Epub 2014 Aug 20. |
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All participants completed Period 1 were randomized 1:1 to 2 groups in Period 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Epinastine / Placebo Period1 | Epinastine / Placebo : Epinastine ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits. |
| FG001 | Epinastine / Epinastine Period1 | Epinastine / Epinastine : Epinastine ophthalmic solution, 1 drop in each eye at designated visits. |
| FG002 | Placebo / Placebo Period1 | Placebo / Placebo : vehicle of DE-114 ophthalmic solution, 1 drop in each eye at designated visits. |
| FG003 | Olopatadine / Placebo Period2 | Olopatadine / Placebo : Olopatadine ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits. |
| FG004 | Epinastine / Placebo Period2 | Epinastine / Placebo : Epinastine ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Epinastine vs Placebo Period1 |
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| ||||||||||||||||||
| Epinastine vs Olopatadine Period2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Epinastine / Epinastine Period1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 . | Posted | Mean | Standard Error | score | Visit 5 (3, 5, and 10 minutes post-CAC) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Epinastine (DE-114) Ophthalmic Solution Period1 | Count unit was defined each eye. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| General Manager of Clinical Development Group | Santen Pharmaceutical Co., Ltd. | +81-6-4802-9341 | clinical@santen.co.jp |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| D000069605 | Olopatadine Hydrochloride |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D003990 | Dibenzoxepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
|
| Olopatadine Hydrochloride 0.1% Ophthalmic Solution | Drug |
|
| 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) |
| COMPLETED |
|
| NOT COMPLETED |
|
Epinastine / Epinastine : DE-114 ophthalmic solution, 1 drop in each eye at designated visits. |
| BG002 | Placebo / Placebo Period1 | Placebo / Placebo : vehicle of DE-114 ophthalmic solution, 1 drop in each eye at designated visits. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male |
| Count of Participants | Participants |
|
|
|
|
| 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 . | Posted | Mean | Standard Error | score | Visit 5 (5, 10, and 20 minutes post-CAC) |
|
|
|
|
| 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 . | Posted | Mean | Standard Error | score | Visit 7 (3, 5, and 10 minutes post-CAC) |
|
|
|
|
| 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 . | Posted | Mean | Standard Error | score | Visit 7 (5, 10, and 20 minutes post-CAC) |
|
|
|
|
| 0 |
| 87 |
| 0 |
| 87 |
| EG001 | Placebo Ophthalmic Solution Period1 | Count unit was defined each eye. | 0 | 87 | 0 | 87 |
| EG002 | Epinastine (DE-114) Ophthalmic Solution Period2 | Count unit was defined each eye. | 0 | 43 | 0 | 43 |
| EG003 | Olopatadine Ophthalmic Solution Period2 | Count unit was defined each eye. | 0 | 43 | 0 | 43 |
| EG004 | Placebo Ophthalmic Solution Period2 | Count unit was defined each eye. | 0 | 86 | 0 | 86 |
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| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |