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

• Status: Completed
• Trial end date: 2019-10-11
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

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

Criteria

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