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

NCT05733624 | Completed Phase 2

• 1 other identifier: SCAI-001-201
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 11

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.

Conditions

Dry Eye Syndromes

Keywords

Dry Eye; Cyclosporine

Outcome Measures

Primary Outcomes (1)

• Tear volume

  Schirmer's test

  Change from baseline at 12 weeks

Secondary Outcomes (7)

• Tear volume

  Change from baseline at 4, 8 weeks

• Corneal staining score with fluorescein

  Change from baseline at 4, 8, 12 weeks

• conjunctival staining score with Lissamine green

  Change from baseline at 4, 8, 12 weeks

• Tear film break-up time

  Change from baseline at 4, 8, 12 weeks

• Standard patient evaluation of eye dryness questionnaire

  Change from baseline at 4, 8, 12 weeks

Study Arms (3)

SCAI-001 0.01%

EXPERIMENTAL

Cyclosporine 0.01%

Drug: SCAI-001 0.01% eyedrop

SCAI-001 0.02%

EXPERIMENTAL

Cyclosporine 0.02%

Drug: SCAI-001 0.02% eyedrop

Restasis

ACTIVE COMPARATOR

Cyclosporine 0.05%

Drug: Restasis 0.05% eyedrop

Interventions

SCAI-001 0.01% eyedrop DRUG

BID for 12weeks

Also known as: Cyclosporine 0.01%

SCAI-001 0.01%

SCAI-001 0.02% eyedrop DRUG

BID for 12weeks

Also known as: Cyclosporine 0.02%

SCAI-001 0.02%

Restasis 0.05% eyedrop DRUG

BID for 12weeks

Also known as: Cyclosporine 0.05%

Restasis

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SCAI Therapeutics: lead

Study Sites (11)

The Catholic University of korea, Bucheon ST.Mary's Hospital

Bucheon-si, South Korea

Location

Inje University Busan Paik Hospital

Busan, South Korea

Location

Pusan National Univ. Hospital

Busan, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, South Korea

Location

Kangbuk Samsung Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Yonsei University Wonju Severance Christian Hospital

Wŏnju, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Ophthalmic Solutions; Cyclosporins

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Lee, MD, PhD

  Pusan National Univ. Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 17, 2023
• Study Start: January 5, 2023
• Primary Completion: August 23, 2023
• Study Completion: February 2, 2024
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (11)