Overview

A Study for Evaluation of the Efficacy and Safety of SI-614 Ophthalmic Solution in Patient With Dry Eye

Status:
Not yet recruiting
Trial end date:
2023-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy and safety of SI-614 ophthalmic solution compared with placebo in patients with dry eye
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Seikagaku Corporation
Collaborators:
ORA, Inc.
Statistics & Data Corporation
Criteria
Inclusion Criteria:

- Have history of dry eye in both eyes for at least 6 months prior to Visit 1.

- Have used and/or desired to use an artificial tear substitute for dry eye symptoms
within 6 months prior to Visit 1.

- If a female of childbearing potential, have a negative urine pregnancy test at Visit 1
and will be using an adequate method of birth control throughout the study period.

Exclusion Criteria:

- Have any clinically significant slit lamp findings at Visit 1 or Visit 2, including
active blepharitis, meibomian gland dysfunction, lid margin inflammation or ocular
allergies that requires therapeutic treatment and/or, in the opinion of the
investigator, may interfere with the study parameters.

- Be diagnosed with an ongoing ocular infection (bacterial, viral or fungal), or active
ocular inflammation (eg, follicular conjunctivitis) at Visit 1 or Visit 2.

- Have had any ocular surgical procedure within 12 months prior to Visit 1, or have any
scheduled ocular surgical procedure during the study period.

- Be a female who is pregnant, nursing an infant, or planning a pregnancy.

- Have a known allergy and/or sensitivity to the study drug or its components.

- Have a condition or is in a situation that, in the opinion of the investigator, may
put the patient at significant risk, may confound the study results, or may interfere
significantly with the patients' participation in the study.