Study to Evaluate the Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED) (SDP-4-CS202)

Silk Technologies

Status and phase: Completed; Phase 2

Conditions: Dry Eye

Treatments: Drug: SDP-4 Ophthalmic Solution (1.0%); Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT04535947

SDP-4-CS202

Details and patient eligibility

About

SDP-4-CS202 is a Phase 2, multicenter, double-masked, randomized, vehicle-controlled, parallel group study designed to evaluate the ocular efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease over an 8-week treatment period. Once concentration (1%) of SDP-4 ophthalmic solution will be given in a parallel group to vehicle via topical ocular instillation BID.

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have DED in both eyes, as supported by a subject-reported history of daily symptoms of dryeye for ≥ 6 months prior to Visit 1/Screening requiring the use of artificial tears.
• Total score ≥ 40 and ≤ 70 on the SANDE questionnaire at Visits 1 and 2.
• Tear break-up time (TBUT) of ≤ 6 seconds in both eyes at Visits 1 and 2.
• Anesthetized Schirmer's test tear volume ≥ 3 mm and <10 mm in both eyes (only at Visit 1).
• Best-corrected visual acuity (BCVA) of +0.7 logMAR or better in each eye as assessed by logMAR chart at Visits 1 and 2.

Exclusion criteria

• Ocular surface corneal disease other than DED.
• Diagnosis of Sjögren's disease.
• Lid margin disorder other than meibomian gland dysfunction (MGD)
• Presence of any ocular condition (e.g., pterygium) that in the Investigator's opinion could affect study parameters.
• Any previous reconstructive or cosmetic eyelid surgery
• 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.
• Cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal within 30 days prior to Visit 1/Screening or planned during the study.
• Contact lens wear.
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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153 participants in 2 patient groups, including a placebo group

Vehicle

Placebo Comparator group

Description:

Vehicle

Treatment:

Drug: Vehicle

SDP-4 Ophthalmic Solution (1.0%)

Experimental group

Description:

Active

Treatment:

Drug: SDP-4 Ophthalmic Solution (1.0%)