Study to Evaluate the Safety and Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED)



Status:Not yet recruiting
Conditions:Ocular, Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:April 2019
End Date:January 31, 2020
Contact:Jamie Christensen
Email:jamiechristensen@silk-tech.com
Phone:763-463-9595

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A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel Group, Dose-Response Study of SDP-4 Ophthalmic Solution in Subjects With Dry Eye Disease (DED)

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.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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
We found this trial at
23
sites
Nashville, Tennessee 37205
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416 West Union Street
Athens, Ohio 45701
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Athens, OH
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Austin, Texas 78731
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Austin, TX
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Brooksville, Florida 34613
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Brooksville, FL
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Cleveland, Ohio 44115
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Cleveland, OH
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Danbury, Connecticut 06810
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Danbury, CT
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Fort Myers, Florida 33901
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Fort Myers, FL
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12665 Garden Grove Boulevard
Garden Grove, California 92843
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Garden Grove, CA
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High Point, North Carolina 27262
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High Point, NC
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Largo, Florida
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Largo, FL
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Lecanto, Florida 34491
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Lecanto, FL
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Memphis, Tennessee
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Memphis, TN
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Mission Hills, California
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Mission Hills, CA
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1000 Corporate Center Drive
Morrow, Georgia 30260
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Morrow, GA
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Nashville, Tennessee 37204
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Nashville, TN
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Newport Beach, California
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Newport Beach, CA
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Petaluma, California 94954
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Petaluma, CA
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Pittsburg, Kansas 66762
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Pittsburg, KS
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Roswell, Georgia 30076
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Roswell, GA
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San Antonio, TX
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Shawnee Mission, Kansas 66204
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Shawnee Mission, KS
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Wantagh, New York
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Wantagh, NY
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Washington, Missouri
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Washington, MO
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