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

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

sites

Danbury Eye Physicians and Surgeons

Danbury, Connecticut 06810

from

Danbury, CT