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

Phase 2

Completed

Conditions: Dry Eye

Interventions: Drug: SDP-4 Ophthalmic Solution (1.0%)
Drug: Vehicle
Drug: SDP-4 Ophthalmic Solution (3.0%)
Drug: SDP-4 Ophthalmic Solution (0.1%)

Registration Number: NCT03889886

Lead Sponsor: Silk Technologies, Ltd.

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 305

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SDP-4 Ophthalmic Solution (1.0%)	SDP-4 Ophthalmic Solution (1.0%)	Mid concentration of SDP-4
Vehicle	Vehicle	Vehicle
SDP-4 Ophthalmic Solution (3.0%)	SDP-4 Ophthalmic Solution (3.0%)	High concentration of SDP-4
SDP-4 Ophthalmic Solution (0.1%)	SDP-4 Ophthalmic Solution (0.1%)	Low concentration of SDP-4

Primary Outcome Measures

Name	Time	Method
Symptom Assessment in Dry Eye (SANDE) Questionnaire	84 days	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.

Secondary Outcome Measures

Name	Time	Method
Anesthetized Schirmer's Test	84 days	Mean change from baseline at Visit7/Day 84
Conjunctival Hyperemia	84 days	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.
Tear Breakup Time	84 days	Mean change from baseline at each visit
Corneal Fluoroscein Staining	84 days	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.

Trial Locations

Locations (26): Canyon City Eyecare
🇺🇸
Azusa, California, United States
Eye Research Foundation
🇺🇸
Newport Beach, California, United States
Eye Associates of Fort Myers
🇺🇸
Fort Myers, Florida, United States
Abrams Eye Center
🇺🇸
Cleveland, Ohio, United States
Heart of America Eye Care, P.A.
🇺🇸
Shawnee Mission, Kansas, United States
Kannarr Eye Care
🇺🇸
Pittsburg, Kansas, United States
Danbury Eye Physicians and Surgeons, PC
🇺🇸
Danbury, Connecticut, United States
Nashville Vision Associates
🇺🇸
Nashville, Tennessee, United States
Total Eye Care
🇺🇸
Memphis, Tennessee, United States
Eye Specialty Group
🇺🇸
Memphis, Tennessee, United States
Orange County Ophthalmology Medical Group
🇺🇸
Garden Grove, California, United States
North Bay Eye Associates
🇺🇸
Petaluma, California, United States
Grutzmacher & Lewis, A Medical Corporation DBA Sacramento Eye Consultants
🇺🇸
Sacramento, California, United States
LoBue Laser and Eye Medical Center
🇺🇸
Murrieta, California, United States
Hernando Eye Institute
🇺🇸
Brooksville, Florida, United States
West Coast Eye Institute
🇺🇸
Lecanto, Florida, United States
Shettle Eye Research
🇺🇸
Largo, Florida, United States
Clayton Eye Clinical Research, LLC
🇺🇸
Morrow, Georgia, United States
Coastal Research Associates
🇺🇸
Roswell, Georgia, United States
Ophthalmology Associates
🇺🇸
Saint Louis, Missouri, United States
Comprehensive Eye Care Ltd
🇺🇸
Washington, Missouri, United States
Wake Forest Health Network Ophthalmology- Oak Hollow
🇺🇸
High Point, North Carolina, United States
Drs. Quinn, Foster & Associates
🇺🇸
Athens, Ohio, United States
Texan Eye / Keystone Research, Ltd.
🇺🇸
Austin, Texas, United States
Medical Center Ophth Assoc / Keystone Research
🇺🇸
San Antonio, Texas, United States
North Valley Eye Medical Group
🇺🇸
Mission Hills, California, United States