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

NCT01363713 | Completed Phase 3 Results

• 1 other identifier: 01141102
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Safety and efficacy of DE-114 ophthalmic solution will be evaluated in patients with allergic conjunctivitis, in an open-label, multicenter study.

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

• Change in Ocular Itching Score by Visit

  Change from baseline in the average of Ocular itching score over the past 3 days. Ocular itching was assessed by the subject and graded on a 5 points scale of 0-4 (0=no itching, 4=incapacitating itch). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined.

  From baseline to 8-week

Other Outcomes (2)

• Change in Palpebral Hyperemia Score by Visit

  From baseline to 8-week

• Change in Bulbar Conjunctiva Hyperemia Score by Visit

  From baseline to 8-week

Study Arms (1)

1

EXPERIMENTAL

Drug: DE-114 ophthalmic solution

Interventions

DE-114 ophthalmic solution DRUG

1

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provided signed, written informed consent.
• Has a positive result from a Type I allergy 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

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

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

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2011
• First Posted: June 1, 2011
• Primary Completion: September 1, 2012
• Last Updated: October 6, 2014
• Results First Posted: September 23, 2014

Record last verified: 2014-09

Locations

JP (1)