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

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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis
• Intervention / Treatment: Drug: Placebo ophthalmic solution; Drug: DE-114 ophthalmic solution; Drug: Olopatadine Hydrochloride 0.1% Ophthalmic Solution

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan
    • Santen study sites

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Santen Pharmaceutical Co., Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Primary Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: May 30, 2011
• First Submitted That Met QC Criteria: May 30, 2011
• First Posted (Estimate): June 1, 2011

Study Record Updates

• Last Update Posted (Estimate): November 19, 2014
• Last Update Submitted That Met QC Criteria: November 5, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Ophthalmic Solutions; Pharmaceutical Solutions; Olopatadine Hydrochloride; Epinastine
• Other Study ID Numbers: 01141101