Title
Study to Evaluate the Safety and Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED)
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)
Phase
Phase 2Lead Sponsor
Silk Technologies, Ltd.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Dry EyeIntervention/Treatment
SDP-4 Ophthalmic Solution (0.1%) SDP-4 Ophthalmic Solution (1.0%) SDP-4 Ophthalmic Solution (3.0%) ...Study Participants
305SDP-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.
Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
Low concentration of SDP-4
Mid concentration of SDP-4
High concentration of SDP-4
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
| Event Type | Organ System | Event Term | Vehicle | SDP-4 Ophthalmic Solution (0.1%) | SDP-4 Ophthalmic Solution (1.0%) | SDP-4 Ophthalmic Solution (3.0%) |
|---|
Mean change from baseline in total SANDE score at Visit 7/Day 84 The SANDE questionnaire contained two questions regarding the frequency and severity of DED symptoms, with a total score being the square root of the frequency score times the square root of the severity score (range 0 100). A higher score indicates more severe DED symptoms.
Mean change from baseline at each visit
Mean change from baseline at Visit7/Day 84
Mean change from baseline at each visit. Reported on a scale of 0-15 with values greater than 3 indicating abnormal incidence of conjunctival surface irregularity.
Mean change from baseline at each visit Reported on a scale of 0-15 with values greater than 3 indicating abnormal incidence of corneal surface irregularity.
