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; Drug: Olopatadine Hydrochloride 0.1% Ophthalmic Solution; Drug: Placebo ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01363700

01141101

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

87 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: DE-114 ophthalmic solution

2

Placebo Comparator group

Treatment:

Drug: Placebo ophthalmic solution

3

Active Comparator group

Treatment:

Drug: Olopatadine Hydrochloride 0.1% Ophthalmic Solution