Status:
COMPLETED
A Study for Evaluation of the Efficacy and Safety of SI-614 Ophthalmic Solution in Patient With Dry Eye
Lead Sponsor:
Seikagaku Corporation
Collaborating Sponsors:
ORA, Inc.
Statistics & Data Corporation
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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
Detailed Description
This is a Phase 3, multicenter, randomized, double-masked study designed to evaluate the efficacy and safety of SI-614 ophthalmic solution compared to placebo in patients with dry eye. Approximately 2...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2023
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT05411367
Start Date
July 28 2022
End Date
April 27 2023
Last Update
March 4 2024
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Eye Research Foundation
Newport Beach, California, United States, 92663
2
Butchertown Clinical Trials
Louisville, Kentucky, United States, 40206
3
Andover Eye Associates, Inc.
Andover, Massachusetts, United States, 01810
4
Center for Sight
Henderson, Nevada, United States, 89052