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

Allergic Conjunctivitis Clinical Trial

Official title:

A Long-term Open-label Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3 -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01363713
• Other study ID #: 01141102
• Status: Completed
• Phase: Phase 3
• First received: May 30, 2011
• Last updated: September 25, 2014

Study information

• Verified date: September 2014
• Source: Santen Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. primary completion date: September 2012
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• 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.

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 Design

N/A

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• DE-114 ophthalmic solution

Locations

Country	Name	City	State
Japan	Santen study sites	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Santen Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Palpebral Hyperemia Score by Visit	Change from baseline of palpebral hyperemia score. Palpebral hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe).; 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	No
Other	Change in Bulbar Conjunctiva Hyperemia Score by Visit	Change from baseline of bulbar conjunctiva hyperemia score. Bulbar conjunctiva hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe).; 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	No
Primary	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	No