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

Dry Eye Syndromes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05733624
• Other study ID #: SCAI-001-201
• Status: Completed
• Phase: Phase 2
• Start date: January 5, 2023
• Est. completion date: February 2, 2024

Study information

• Verified date: February 2024
• Source: SCAI Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: February 2, 2024
• Est. primary completion date: August 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• SCAI-001 0.01% eyedrop
BID for 12weeks
• SCAI-001 0.02% eyedrop
BID for 12weeks
• Restasis 0.05% eyedrop
BID for 12weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
SCAI Therapeutics

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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