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

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SI-614
Vehicle
Sponsored by
Seikagaku Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eye Research Foundation
  • Butchertown Clinical Trials
  • Andover Eye Associates, Inc.
  • Center for Sight
  • CORE Inc, Vita Eye Clinic
  • Total Eye Care, PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SI-614

Vehicle

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline to Day 29 in fluorescein staining score

Secondary Outcome Measures

Change from baseline to Day 14 in ocular symptom score

Full Information

First Posted
June 5, 2022
Last Updated
May 15, 2023
Sponsor
Seikagaku Corporation
Collaborators
ORA, Inc., Statistics & Data Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05411367
Brief Title
A Study for Evaluation of the Efficacy and Safety of SI-614 Ophthalmic Solution in Patient With Dry Eye
Acronym
SIDE
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 28, 2022 (Actual)
Primary Completion Date
March 2, 2023 (Actual)
Study Completion Date
April 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seikagaku Corporation
Collaborators
ORA, Inc., Statistics & Data Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SI-614
Arm Type
Experimental
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SI-614
Intervention Description
1 drop in each eye
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
1 drop in each eye
Primary Outcome Measure Information:
Title
Change from baseline to Day 29 in fluorescein staining score
Time Frame
29 days
Secondary Outcome Measure Information:
Title
Change from baseline to Day 14 in ocular symptom score
Time Frame
14 days
Other Pre-specified Outcome Measures:
Title
Best-corrected Visual Acuity
Time Frame
Up to 84 days
Title
Slit-lamp Biomicroscopy
Time Frame
Up to 84 days
Title
Adverse Events
Time Frame
Up to 84 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Ousler
Organizational Affiliation
ORA, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Butchertown Clinical Trials
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Andover Eye Associates, Inc.
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Center for Sight
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
CORE Inc, Vita Eye Clinic
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Total Eye Care, PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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