Study to Evaluate the Safety and Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED) (SDP-4-CS201)

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Vehicle; Drug: SDP-4 Ophthalmic Solution (0.1%); Drug: SDP-4 Ophthalmic Solution (1.0%); Drug: SDP-4 Ophthalmic Solution (3.0%)

• Study Type: Interventional
• Enrollment (Actual): 305
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Azusa, California, United States, 91702
      • Canyon City Eyecare
    • Garden Grove, California, United States, 92843
      • Orange County Ophthalmology Medical Group
    • Mission Hills, California, United States, 91345
      • North Valley Eye Medical Group
    • Murrieta, California, United States, 92562
      • LoBue Laser and Eye Medical Center
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates
    • Sacramento, California, United States, 95815
      • Grutzmacher & Lewis, A Medical Corporation DBA Sacramento Eye Consultants
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Danbury Eye Physicians and Surgeons, PC
  • Florida
    • Brooksville, Florida, United States, 34615
      • Hernando Eye Institute
    • Fort Myers, Florida, United States, 33901
      • Eye Associates of Fort Myers
    • Largo, Florida, United States, 33773
      • Shettle Eye Research
    • Lecanto, Florida, United States, 34461
      • West Coast Eye Institute
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Clayton Eye Clinical Research, LLC
    • Roswell, Georgia, United States, 30076
      • Coastal Research Associates
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care
    • Shawnee Mission, Kansas, United States, 66204
      • Heart of America Eye Care, P.A.
  • Missouri
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Associates
    • Washington, Missouri, United States, 63090
      • Comprehensive Eye Care Ltd
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Wake Forest Health Network Ophthalmology- Oak Hollow
  • Ohio
    • Athens, Ohio, United States, 45701
      • Drs. Quinn, Foster & Associates
    • Cleveland, Ohio, United States, 44115
      • Abrams Eye Center
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care
    • Memphis, Tennessee, United States, 38120
      • Eye Specialty Group
    • Nashville, Tennessee, United States, 37205
      • Nashville Vision Associates
  • Texas
    • Austin, Texas, United States, 78731
      • Texan Eye / Keystone Research, Ltd.
    • San Antonio, Texas, United States, 78240
      • Medical Center Ophth Assoc / Keystone Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Vehicle	Drug: Vehicle; 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.
EXPERIMENTAL: SDP-4 Ophthalmic Solution (0.1%); Low concentration of SDP-4	Drug: SDP-4 Ophthalmic Solution (0.1%); 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.; Other Names: SDP-4 (0.1%)
EXPERIMENTAL: SDP-4 Ophthalmic Solution (1.0%); Mid concentration of SDP-4	Drug: SDP-4 Ophthalmic Solution (1.0%); 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.; Other Names: SDP-4 (1.0%)
EXPERIMENTAL: SDP-4 Ophthalmic Solution (3.0%); High concentration of SDP-4	Drug: SDP-4 Ophthalmic Solution (3.0%); 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.; Other Names: SDP-4 (3.0%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom Assessment in Dry Eye (SANDE) Questionnaire	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.	84 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Silk Technologies, Ltd.
• Investigators: Study Director: Jamie Christensen, Silk Technologies

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 16, 2019
• Primary Completion (ACTUAL): October 7, 2019
• Study Completion (ACTUAL): October 11, 2019

Study Registration Dates

• First Submitted: March 22, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (ACTUAL): March 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2022
• Last Update Submitted That Met QC Criteria: August 11, 2022
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: SDP-4-CS201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No