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Clinical Trial to Evaluate the Safety and Efficacy of SCAI-001 Compared to Restasis

Primary Purpose

Dry Eye Syndromes

Status
Active
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SCAI-001 0.01% eyedrop
SCAI-001 0.02% eyedrop
Restasis 0.05% eyedrop
Sponsored by
SCAI Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes focused on measuring Dry Eye, Cyclosporine

Eligibility Criteria

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

Inclusion Criteria: Male and Female who over 19 years old Those who have dry eye symptoms (Dryness, Grittiness, soreness, irritation, watering, etc.) Those who meet below criteria at least one of two eyes; Those who have over than score 2 in corneal staining test-Oxford grading Tear secretion test without anesthesia(Schirmer test) result would be under 10mm/5min (If the test result is 0mm/5min, it should be over than 3mm/5min on the nasal stimulation schirmer test in the same eye) TBUT(Tear film break-up time) test result should be under 10sec. The corrected visual acuity is 0.2 or more. Exclusion Criteria: Those who have clinically significant eye disease not related to dry eye syndrome Those who are in medication of systemic steroid or immunosuppressant 90days before screening visit Those who have worn contact lenses before 72hours or have to wear contact lenses or disagree not to wear contact lenses during study period Those who have medical history with intraocular surgery 12months before screening visit Those who have diagnosed with glaucoma or have an intraocular pressure over than 21mmHg at least in one of the eyes Those who have medicated cyclosporine eye-drops 6weeks before screening visit Those who have underwent any eye correction surgery such as LASIK(Laser-assistant in situ keratomileusis) 12 months before screening visit Those who have underwent a silicone lacrimal punctal occlusion or cauterization of the punctum excluding collagen lacrimal punctal occlusion 90 days before screening visit Those who have received other investigational drugs/devices 30 days before screening visit Those who are inappropriate for participating in this study according to investigator's judgement

Sites / Locations

  • The Catholic University of korea, Bucheon ST.Mary's Hospital
  • Inje University Busan Paik Hospital
  • Pusan National Univ. Hospital
  • Kyungpook National University Hospital
  • Asan Medical Center
  • Hallym University Kangnam Sacred Heart Hospital
  • Kangbuk Samsung Hospital
  • Korea University Anam Hospital
  • Korea University Guro Hospital
  • Yonsei University Wonju Severance Christian Hospital
  • Pusan National University Yangsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

SCAI-001 0.01%

SCAI-001 0.02%

Restasis

Arm Description

Cyclosporine 0.01%

Cyclosporine 0.02%

Cyclosporine 0.05%

Outcomes

Primary Outcome Measures

Tear volume
Schirmer's test

Secondary Outcome Measures

Tear volume
Schirmer's test
Corneal staining score with fluorescein
Oxford grading
conjunctival staining score with Lissamine green
Oxford grading
Tear film break-up time
Measured three times and recorded up to 1/100
Standard patient evaluation of eye dryness questionnaire
written by the subject
Ocular surface disease index
written by the subject
Total number of rescue medication used
sourced by patient diary

Full Information

First Posted
February 8, 2023
Last Updated
May 19, 2023
Sponsor
SCAI Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05733624
Brief Title
Clinical Trial to Evaluate the Safety and Efficacy of SCAI-001 Compared to Restasis
Official Title
A Multicenter, Active Control, Parallel Group, Randomized, Double-blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of SCAI-001 Eye Drops in Patients With Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SCAI Therapeutics

4. Oversight

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

5. Study Description

Brief Summary
This study is planned to Evaluate the Efficacy and Safety of SCAI-001 Eye Drops(Cyclosporine 0.01%, 0.02%) compared to Restasis(Cyclosporine 0.05%) in Patients with Dry Eye Disease.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SCAI-001 0.01%
Arm Type
Experimental
Arm Description
Cyclosporine 0.01%
Arm Title
SCAI-001 0.02%
Arm Type
Experimental
Arm Description
Cyclosporine 0.02%
Arm Title
Restasis
Arm Type
Active Comparator
Arm Description
Cyclosporine 0.05%
Intervention Type
Drug
Intervention Name(s)
SCAI-001 0.01% eyedrop
Other Intervention Name(s)
Cyclosporine 0.01%
Intervention Description
BID for 12weeks
Intervention Type
Drug
Intervention Name(s)
SCAI-001 0.02% eyedrop
Other Intervention Name(s)
Cyclosporine 0.02%
Intervention Description
BID for 12weeks
Intervention Type
Drug
Intervention Name(s)
Restasis 0.05% eyedrop
Other Intervention Name(s)
Cyclosporine 0.05%
Intervention Description
BID for 12weeks
Primary Outcome Measure Information:
Title
Tear volume
Description
Schirmer's test
Time Frame
Change from baseline at 12 weeks
Secondary Outcome Measure Information:
Title
Tear volume
Description
Schirmer's test
Time Frame
Change from baseline at 4, 8 weeks
Title
Corneal staining score with fluorescein
Description
Oxford grading
Time Frame
Change from baseline at 4, 8, 12 weeks
Title
conjunctival staining score with Lissamine green
Description
Oxford grading
Time Frame
Change from baseline at 4, 8, 12 weeks
Title
Tear film break-up time
Description
Measured three times and recorded up to 1/100
Time Frame
Change from baseline at 4, 8, 12 weeks
Title
Standard patient evaluation of eye dryness questionnaire
Description
written by the subject
Time Frame
Change from baseline at 4, 8, 12 weeks
Title
Ocular surface disease index
Description
written by the subject
Time Frame
Change from baseline at 4, 8, 12 weeks
Title
Total number of rescue medication used
Description
sourced by patient diary
Time Frame
12weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and Female who over 19 years old Those who have dry eye symptoms (Dryness, Grittiness, soreness, irritation, watering, etc.) Those who meet below criteria at least one of two eyes; Those who have over than score 2 in corneal staining test-Oxford grading Tear secretion test without anesthesia(Schirmer test) result would be under 10mm/5min (If the test result is 0mm/5min, it should be over than 3mm/5min on the nasal stimulation schirmer test in the same eye) TBUT(Tear film break-up time) test result should be under 10sec. The corrected visual acuity is 0.2 or more. Exclusion Criteria: Those who have clinically significant eye disease not related to dry eye syndrome Those who are in medication of systemic steroid or immunosuppressant 90days before screening visit Those who have worn contact lenses before 72hours or have to wear contact lenses or disagree not to wear contact lenses during study period Those who have medical history with intraocular surgery 12months before screening visit Those who have diagnosed with glaucoma or have an intraocular pressure over than 21mmHg at least in one of the eyes Those who have medicated cyclosporine eye-drops 6weeks before screening visit Those who have underwent any eye correction surgery such as LASIK(Laser-assistant in situ keratomileusis) 12 months before screening visit Those who have underwent a silicone lacrimal punctal occlusion or cauterization of the punctum excluding collagen lacrimal punctal occlusion 90 days before screening visit Those who have received other investigational drugs/devices 30 days before screening visit Those who are inappropriate for participating in this study according to investigator's judgement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee, MD, PhD
Organizational Affiliation
Pusan National Univ. Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Catholic University of korea, Bucheon ST.Mary's Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Pusan National Univ. Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Hallym University Kangnam Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Wonju Severance Christian Hospital
City
Wŏnju
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Trial to Evaluate the Safety and Efficacy of SCAI-001 Compared to Restasis

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