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

Sponsor
Seikagaku Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05411367
Collaborator
ORA, Inc. (Industry), Statistics & Data Corporation (Other)
230
Enrollment
3
Locations
2
Arms
9.1
Anticipated Duration (Months)
76.7
Patients Per Site
8.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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 230 male and female patients at least 18 years of age with dry eye in both eyes will be randomized to receive treatment with SI-614 or placebo in a 1:1 ratio.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
230 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-masked and Placebo-controlled Study Evaluating the Efficacy and Safety of SI-614 Ophthalmic Solution in Patients With Dry Eye
Actual Study Start Date :
Jul 28, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: SI-614

Drug: SI-614
1 drop in each eye
Placebo Comparator: Vehicle

Drug: Vehicle
1 drop in each eye

Outcome Measures

Primary Outcome Measures

  1. Change from baseline to Day 29 in fluorescein staining score [29 days]

Secondary Outcome Measures

  1. Change from baseline to Day 14 in ocular symptom score [14 days]

Other Outcome Measures

  1. Best-corrected Visual Acuity [Up to 84 days]

  2. Slit-lamp Biomicroscopy [Up to 84 days]

  3. Adverse Events [Up to 84 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Andover Eye Associates, Inc. Andover Massachusetts United States 01810
2 CORE Inc, Vita Eye Clinic Shelby North Carolina United States 28150
3 Total Eye Care, PA Memphis Tennessee United States 38119

Sponsors and Collaborators

  • Seikagaku Corporation
  • ORA, Inc.
  • Statistics & Data Corporation

Investigators

  • Study Director: George Ousler, ORA, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seikagaku Corporation
ClinicalTrials.gov Identifier:
NCT05411367
Other Study ID Numbers:
  • 614/1132
First Posted:
Jun 9, 2022
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases

Study Results

No Results Posted as of Aug 22, 2022