Trial Outcomes & Findings for Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis (NCT NCT01363700)

Results Overview

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 .

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

87 participants

Primary outcome timeframe

Visit 5 (3, 5, and 10 minutes post-CAC)

Results posted on

2014-11-19

Participant Flow

* Period1 comparison with placebo (Epinastine vs Placebo) * Period2 comparison with olopatadine (Epinastine vs Olopatadine)

All participants completed Period 1 were randomized 1:1 to 2 groups in Period 2.

Participant milestones

Participant milestones
Measure	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.	Epinastine / Epinastine Period1 Epinastine / Epinastine : Epinastine ophthalmic solution, 1 drop in each eye at designated visits.	Placebo / Placebo Period1 Placebo / Placebo : vehicle of DE-114 ophthalmic solution, 1 drop in each eye at designated visits.	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.	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.
Epinastine vs Placebo Period1 STARTED	43	22	22	0	0
Epinastine vs Placebo Period1 COMPLETED	43	21	22	0	0
Epinastine vs Placebo Period1 NOT COMPLETED	0	1	0	0	0
Epinastine vs Olopatadine Period2 STARTED	0	0	0	43	43
Epinastine vs Olopatadine Period2 COMPLETED	0	0	0	43	43
Epinastine vs Olopatadine Period2 NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Epinastine / Epinastine Period1 Epinastine / Epinastine : Epinastine ophthalmic solution, 1 drop in each eye at designated visits.	Placebo / Placebo Period1 Placebo / Placebo : vehicle of DE-114 ophthalmic solution, 1 drop in each eye at designated visits.	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.	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.
Epinastine vs Placebo Period1 Withdrawal by Subject	0	1	0	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Epinastine / Placebo Period1 n=43 Participants 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.	Epinastine / Epinastine Period1 n=22 Participants Epinastine / Epinastine : DE-114 ophthalmic solution, 1 drop in each eye at designated visits.	Placebo / Placebo Period1 n=22 Participants Placebo / Placebo : vehicle of DE-114 ophthalmic solution, 1 drop in each eye at designated visits.	Total n=87 Participants Total of all reporting groups
Age, Continuous	39.5 years STANDARD_DEVIATION 11.0 • n=5 Participants	39.0 years STANDARD_DEVIATION 10.0 • n=7 Participants	39.7 years STANDARD_DEVIATION 11.7 • n=5 Participants	39.4 years STANDARD_DEVIATION 10.8 • n=4 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	39 Participants n=4 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	48 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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 .

Outcome measures

Outcome measures
Measure	Epinastine (DE-114) Ophthalmic Solution n=87 Participants Count unit was defined each eye.	Placebo Ophthalmic Solution n=87 Participants Count unit was defined each eye.	Placebo Ophthalmic Solution Count unit was defined each eye.
Mean Ocular Itching Score Compared to Placebo Period1	0.4 score Standard Error 0.1	1.7 score Standard Error 0.1	—

PRIMARY outcome

Timeframe: 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 .

Outcome measures

Outcome measures
Measure	Epinastine (DE-114) Ophthalmic Solution n=87 Participants Count unit was defined each eye.	Placebo Ophthalmic Solution n=87 Participants Count unit was defined each eye.	Placebo Ophthalmic Solution Count unit was defined each eye.
Mean Hyperemia Score Compared to Placebo Period1	2.7 score Standard Error 0.1	4.1 score Standard Error 0.2	—

SECONDARY outcome

Timeframe: 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 .

Outcome measures

Outcome measures
Measure	Epinastine (DE-114) Ophthalmic Solution n=43 Participants Count unit was defined each eye.	Placebo Ophthalmic Solution n=43 Participants Count unit was defined each eye.	Placebo Ophthalmic Solution n=86 Participants Count unit was defined each eye.
Mean Ocular Itching Score Compared to Olopatadine Period2	0.2 score Standard Error 0.1	0.2 score Standard Error 0.1	1.5 score Standard Error 0.1

SECONDARY outcome

Timeframe: 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 .