Clinical trial NCT05733624: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Keywords: Dry Eye
Cyclosporine
Lead sponsor: SCAI Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-02-17
Enrollment: 116
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Tear volume
timeFrame: Change from baseline at 12 weeks
Secondary outcomes:
measure: Tear volume
timeFrame: Change from baseline at 4, 8 weeks
measure: Corneal staining score with fluorescein
timeFrame: Change from baseline at 4, 8, 12 weeks
measure: conjunctival staining score with Lissamine green
timeFrame: Change from baseline at 4, 8, 12 weeks
measure: Tear film break-up time
timeFrame: Change from baseline at 4, 8, 12 weeks
measure: Standard patient evaluation of eye dryness questionnaire
timeFrame: Change from baseline at 4, 8, 12 weeks
measure: Ocular surface disease index
timeFrame: Change from baseline at 4, 8, 12 weeks
measure: Total number of rescue medication used
timeFrame: 12weeks
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of korea, Bucheon ST.Mary's Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National Univ. Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Wŏnju
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Pusan National Univ. Hospital
name: Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: