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

Santen

Status and phase: Completed; Phase 3

Conditions: Allergic Conjunctivitis

Treatments: Drug: DE-114 ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01363713

01141102

Details and patient eligibility

About

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

Enrollment: 130 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

130 participants in 1 patient group

1

Experimental group

Treatment:

Drug: DE-114 ophthalmic solution