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

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: SCAI-001 0.01% eyedrop; Drug: SCAI-001 0.02% eyedrop; Drug: Restasis 0.05% eyedrop

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male and Female who over 19 years old
2. Those who have dry eye symptoms (Dryness, Grittiness, soreness, irritation, watering, etc.)

3. 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.
4. The corrected visual acuity is 0.2 or more.

Exclusion Criteria:

1. Those who have clinically significant eye disease not related to dry eye syndrome
2. Those who are in medication of systemic steroid or immunosuppressant 90days before screening visit
3. Those who have worn contact lenses before 72hours or have to wear contact lenses or disagree not to wear contact lenses during study period
4. Those who have medical history with intraocular surgery 12months before screening visit
5. Those who have diagnosed with glaucoma or have an intraocular pressure over than 21mmHg at least in one of the eyes
6. Those who have medicated cyclosporine eye-drops 6weeks before screening visit
7. Those who have underwent any eye correction surgery such as LASIK(Laser-assistant in situ keratomileusis) 12 months before screening visit
8. Those who have underwent a silicone lacrimal punctal occlusion or cauterization of the punctum excluding collagen lacrimal punctal occlusion 90 days before screening visit
9. Those who have received other investigational drugs/devices 30 days before screening visit
10. Those who are inappropriate for participating in this study according to investigator's judgement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCAI-001 0.01%; Cyclosporine 0.01%	Drug: SCAI-001 0.01% eyedrop; BID for 12weeks; Other Names: Cyclosporine 0.01%
Experimental: SCAI-001 0.02%; Cyclosporine 0.02%	Drug: SCAI-001 0.02% eyedrop; BID for 12weeks; Other Names: Cyclosporine 0.02%
Active Comparator: Restasis; Cyclosporine 0.05%	Drug: Restasis 0.05% eyedrop; BID for 12weeks; Other Names: Cyclosporine 0.05%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear volume	Schirmer's test	Change from baseline at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear volume	Schirmer's test	Change from baseline at 4, 8 weeks
Corneal staining score with fluorescein	Oxford grading	Change from baseline at 4, 8, 12 weeks
conjunctival staining score with Lissamine green	Oxford grading	Change from baseline at 4, 8, 12 weeks
Tear film break-up time	Measured three times and recorded up to 1/100	Change from baseline at 4, 8, 12 weeks
Standard patient evaluation of eye dryness questionnaire	written by the subject	Change from baseline at 4, 8, 12 weeks
Ocular surface disease index	written by the subject	Change from baseline at 4, 8, 12 weeks
Total number of rescue medication used	sourced by patient diary	12weeks

Collaborators and Investigators

• Sponsor: SCAI Therapeutics
• Investigators: Principal Investigator: Lee, MD, PhD, Pusan National Univ. Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Actual): August 23, 2023
• Study Completion (Actual): February 2, 2024

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Dry Eye; Cyclosporine
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Pharmaceutical Solutions; Calcineurin Inhibitors; Ophthalmic Solutions; Cyclosporine; Cyclosporins
• Other Study ID Numbers: SCAI-001-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No