Double-masked, Comparison Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3, Confirmatory Study -
Overview
- Phase
- Phase 3
- Intervention
- DE-114 ophthalmic solution
- Conditions
- Allergic Conjunctivitis
- Sponsor
- Santen Pharmaceutical Co., Ltd.
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- Mean Ocular Itching Score Compared to Placebo Period1
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
1
Intervention: DE-114 ophthalmic solution
2
Intervention: Placebo ophthalmic solution
3
Intervention: Olopatadine Hydrochloride 0.1% Ophthalmic Solution
Outcomes
Primary Outcomes
Mean Ocular Itching Score Compared to Placebo Period1
Time Frame: 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
Time Frame: 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 Outcomes
- Mean Hyperemia Score Compared to Olopatadine Period2(Visit 7 (5, 10, and 20 minutes post-CAC))
- Mean Ocular Itching Score Compared to Olopatadine Period2(Visit 7 (3, 5, and 10 minutes post-CAC))