Study to Evaluate the Safety and Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED)
Completed · Phase 2
Conditions studied: Dry Eye
In brief
SDP-4-CS201, is a Phase 2, multi-center, double-masked, randomized, vehicle-controlled, dose-response, parallel-group study designed to evaluate the ocular and systemic safety and efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease over a 12-week treatment period. Three concentrations (0.1%, 1.0% and 3.0%) of SDP-4 ophthalmic solution will be given to parallel groups via topical ocular instillation BID.
Key facts
- Study ID
- NCT03889886
- Run by
- Silk Technologies, Ltd.
- People needed
- 305
- Starts
- 2019-04-16
- Expected to finish
- 2019-10-11
- Last updated by the study team
- 2022-09-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Have DED in both eyes for ≥ 6 months prior to Visit 1/Screening.
- 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.
You may not qualify if…
- Ocular surface corneal disease, other than DED.
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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