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

NCT01363700 | Completed Phase 3 Results

• 1 other identifier: 01141101
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Mean Ocular Itching Score Compared to Olopatadine Period2

  Visit 7 (3, 5, and 10 minutes post-CAC)

• Mean Hyperemia Score Compared to Olopatadine Period2

  Visit 7 (5, 10, and 20 minutes post-CAC)

Study Arms (3)

1

EXPERIMENTAL

Drug: DE-114 ophthalmic solution

2

PLACEBO COMPARATOR

Drug: Placebo ophthalmic solution

3

ACTIVE COMPARATOR

Drug: Olopatadine Hydrochloride 0.1% Ophthalmic Solution

Interventions

DE-114 ophthalmic solution DRUG

Also known as: Epinastine ophthalmic solution

1

Placebo ophthalmic solution DRUG

2

Olopatadine Hydrochloride 0.1% Ophthalmic Solution DRUG

3

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Santen Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Santen study sites

Osaka, Japan

Location

Related Publications (1)

• 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.

  PMID: 25163405 DERIVED

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Olopatadine Hydrochloride; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: General Manager of Clinical Development Group
• Organization: Santen Pharmaceutical Co., Ltd.

clinical@santen.co.jp

+81-6-4802-9341

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 30, 2011
• First Posted: June 1, 2011
• Primary Completion: June 1, 2012
• Last Updated: November 19, 2014
• Results First Posted: November 5, 2014

Record last verified: 2014-11

Locations

JP (1)