Study to Evaluate the Safety and Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED)
NCT ID: NCT03889886
Last Updated: 2022-09-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
305 participants
INTERVENTIONAL
2019-04-16
2019-10-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vehicle
Vehicle
Vehicle
Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
SDP-4 Ophthalmic Solution (0.1%)
Low concentration of SDP-4
SDP-4 Ophthalmic Solution (0.1%)
Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
SDP-4 Ophthalmic Solution (1.0%)
Mid concentration of SDP-4
SDP-4 Ophthalmic Solution (1.0%)
Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
SDP-4 Ophthalmic Solution (3.0%)
High concentration of SDP-4
SDP-4 Ophthalmic Solution (3.0%)
Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
Interventions
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SDP-4 Ophthalmic Solution (0.1%)
Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
SDP-4 Ophthalmic Solution (1.0%)
Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
SDP-4 Ophthalmic Solution (3.0%)
Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
Vehicle
Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Total score ≥ 40 on the SANDE questionnaire.
* Tear break-up time (TBUT) of ≤ 6 seconds in both eyes.
* Anesthetized Schirmer's test tear volume ≥ 4 mm and \<10 mm in both eyes.
Exclusion Criteria
* Lid margin disorder other than meibomian gland dysfunction (MGD).
* Any previous reconstructive or cosmetic eyelid surgery that may affect the normal function of the lids
* Any previous invasive glaucoma and/or corneal surgery
* Corneal refractive surgery in the 12 months prior to Visit 1/Screening.
* Cataract extraction within 90 days prior to Visit 1/Screening.
* Use of ophthlamic corticosteroids, NSAIDs, antibiotics, antihistamines, IOP lowering medication, in the 30 days prior to Visit 1/Screening
* Serious systemic disease or uncontrolled medical condition that in the judgment of the Investigator could confound study assessments
18 Years
ALL
No
Sponsors
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Silk Technologies, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jamie Christensen
Role: STUDY_DIRECTOR
Silk Technologies
Locations
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Canyon City Eyecare
Azusa, California, United States
Orange County Ophthalmology Medical Group
Garden Grove, California, United States
North Valley Eye Medical Group
Mission Hills, California, United States
LoBue Laser and Eye Medical Center
Murrieta, California, United States
Eye Research Foundation
Newport Beach, California, United States
North Bay Eye Associates
Petaluma, California, United States
Grutzmacher & Lewis, A Medical Corporation DBA Sacramento Eye Consultants
Sacramento, California, United States
Danbury Eye Physicians and Surgeons, PC
Danbury, Connecticut, United States
Hernando Eye Institute
Brooksville, Florida, United States
Eye Associates of Fort Myers
Fort Myers, Florida, United States
Shettle Eye Research
Largo, Florida, United States
West Coast Eye Institute
Lecanto, Florida, United States
Clayton Eye Clinical Research, LLC
Morrow, Georgia, United States
Coastal Research Associates
Roswell, Georgia, United States
Kannarr Eye Care
Pittsburg, Kansas, United States
Heart of America Eye Care, P.A.
Shawnee Mission, Kansas, United States
Ophthalmology Associates
St Louis, Missouri, United States
Comprehensive Eye Care Ltd
Washington, Missouri, United States
Wake Forest Health Network Ophthalmology- Oak Hollow
High Point, North Carolina, United States
Drs. Quinn, Foster & Associates
Athens, Ohio, United States
Abrams Eye Center
Cleveland, Ohio, United States
Total Eye Care
Memphis, Tennessee, United States
Eye Specialty Group
Memphis, Tennessee, United States
Nashville Vision Associates
Nashville, Tennessee, United States
Texan Eye / Keystone Research, Ltd.
Austin, Texas, United States
Medical Center Ophth Assoc / Keystone Research
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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SDP-4-CS201
Identifier Type: -
Identifier Source: org_study_id
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