Clinical trial NCT03889886: Study to Evaluate the Safety and Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Lead sponsor: Silk Technologies, Ltd.
Sponsor class: INDUSTRY
First posted: 2019-03-26
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to 1 of 3 concentrations (0.1%, 1.0% and 3.0%) of SDP-4 Ophthalmic Solution or vehicle in a 1:1:1:1 ratio in parallel groups.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Symptom Assessment in Dry Eye (SANDE) Questionnaire
timeFrame: 84 days
Secondary outcomes:
measure: Tear Breakup Time
timeFrame: 84 days
measure: Anesthetized Schirmer's Test
timeFrame: 84 days
measure: Conjunctival Hyperemia
timeFrame: 84 days
measure: Corneal Fluoroscein Staining
timeFrame: 84 days
Other outcomes:
Locations:
city: Azusa
country: United States
facility: Canyon City Eyecare
state: California
city: Garden Grove
country: United States
facility: Orange County Ophthalmology Medical Group
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group
state: California
city: Murrieta
country: United States
facility: LoBue Laser and Eye Medical Center
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates
state: California
city: Sacramento
country: United States
facility: Grutzmacher & Lewis, A Medical Corporation DBA Sacramento Eye Consultants
state: California
city: Danbury
country: United States
facility: Danbury Eye Physicians and Surgeons, PC
state: Connecticut
city: Brooksville
country: United States
facility: Hernando Eye Institute
state: Florida
city: Fort Myers
country: United States
facility: Eye Associates of Fort Myers
state: Florida
city: Largo
country: United States
facility: Shettle Eye Research
state: Florida
city: Lecanto
country: United States
facility: West Coast Eye Institute
state: Florida
city: Morrow
country: United States
facility: Clayton Eye Clinical Research, LLC
state: Georgia
city: Roswell
country: United States
facility: Coastal Research Associates
state: Georgia
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Shawnee Mission
country: United States
facility: Heart of America Eye Care, P.A.
state: Kansas
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Washington
country: United States
facility: Comprehensive Eye Care Ltd
state: Missouri
city: High Point
country: United States
facility: Wake Forest Health Network Ophthalmology- Oak Hollow
state: North Carolina
city: Athens
country: United States
facility: Drs. Quinn, Foster & Associates
state: Ohio
city: Cleveland
country: United States
facility: Abrams Eye Center
state: Ohio
city: Memphis
country: United States
facility: Total Eye Care
state: Tennessee
city: Memphis
country: United States
facility: Eye Specialty Group
state: Tennessee
city: Nashville
country: United States
facility: Nashville Vision Associates
state: Tennessee
city: Austin
country: United States
facility: Texan Eye / Keystone Research, Ltd.
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophth Assoc / Keystone Research
state: Texas
Study officials:
affiliation: Silk Technologies
name: Jamie Christensen
role: STUDY_DIRECTOR
References: