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

• Status: Completed
• Trial end date: 2021-02-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Silk Technologies, Ltd.
• Treatments: Ophthalmic Solutions

Criteria

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