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

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SDP-4 Ophthalmic Solution (0.1%)
SDP-4 Ophthalmic Solution (1.0%)
SDP-4 Ophthalmic Solution (3.0%)
Vehicle
Sponsored by
Silk Technologies, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Canyon City Eyecare
  • Orange County Ophthalmology Medical Group
  • North Valley Eye Medical Group
  • LoBue Laser and Eye Medical Center
  • Eye Research Foundation
  • North Bay Eye Associates
  • Grutzmacher & Lewis, A Medical Corporation DBA Sacramento Eye Consultants
  • Danbury Eye Physicians and Surgeons, PC
  • Hernando Eye Institute
  • Eye Associates of Fort Myers
  • Shettle Eye Research
  • West Coast Eye Institute
  • Clayton Eye Clinical Research, LLC
  • Coastal Research Associates
  • Kannarr Eye Care
  • Heart of America Eye Care, P.A.
  • Ophthalmology Associates
  • Comprehensive Eye Care Ltd
  • Wake Forest Health Network Ophthalmology- Oak Hollow
  • Drs. Quinn, Foster & Associates
  • Abrams Eye Center
  • Total Eye Care
  • Eye Specialty Group
  • Nashville Vision Associates
  • Texan Eye / Keystone Research, Ltd.
  • Medical Center Ophth Assoc / Keystone Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Vehicle

SDP-4 Ophthalmic Solution (0.1%)

SDP-4 Ophthalmic Solution (1.0%)

SDP-4 Ophthalmic Solution (3.0%)

Arm Description

Vehicle

Low concentration of SDP-4

Mid concentration of SDP-4

High concentration of SDP-4

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Tear Breakup Time
Mean change from baseline at each visit
Anesthetized Schirmer's Test
Mean change from baseline at Visit7/Day 84
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.
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.

Full Information

First Posted
March 22, 2019
Last Updated
August 11, 2022
Sponsor
Silk Technologies, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03889886
Brief Title
Study to Evaluate the Safety and Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED)
Acronym
SDP-4-CS201
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
October 7, 2019 (Actual)
Study Completion Date
October 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Silk Technologies, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All investigational product (SDP-4 concentrations and vehicle) will be provided in single-use doses (SUDs) contained in foil pouches.
Allocation
Randomized
Enrollment
305 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle
Arm Title
SDP-4 Ophthalmic Solution (0.1%)
Arm Type
Experimental
Arm Description
Low concentration of SDP-4
Arm Title
SDP-4 Ophthalmic Solution (1.0%)
Arm Type
Experimental
Arm Description
Mid concentration of SDP-4
Arm Title
SDP-4 Ophthalmic Solution (3.0%)
Arm Type
Experimental
Arm Description
High concentration of SDP-4
Intervention Type
Drug
Intervention Name(s)
SDP-4 Ophthalmic Solution (0.1%)
Other Intervention Name(s)
SDP-4 (0.1%)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
SDP-4 Ophthalmic Solution (1.0%)
Other Intervention Name(s)
SDP-4 (1.0%)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
SDP-4 Ophthalmic Solution (3.0%)
Other Intervention Name(s)
SDP-4 (3.0%)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
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.
Primary Outcome Measure Information:
Title
Symptom Assessment in Dry Eye (SANDE) Questionnaire
Description
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.
Time Frame
84 days
Secondary Outcome Measure Information:
Title
Tear Breakup Time
Description
Mean change from baseline at each visit
Time Frame
84 days
Title
Anesthetized Schirmer's Test
Description
Mean change from baseline at Visit7/Day 84
Time Frame
84 days
Title
Conjunctival Hyperemia
Description
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.
Time Frame
84 days
Title
Corneal Fluoroscein Staining
Description
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.
Time Frame
84 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie Christensen
Organizational Affiliation
Silk Technologies
Official's Role
Study Director
Facility Information:
Facility Name
Canyon City Eyecare
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
Orange County Ophthalmology Medical Group
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
North Valley Eye Medical Group
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
LoBue Laser and Eye Medical Center
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
North Bay Eye Associates
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Grutzmacher & Lewis, A Medical Corporation DBA Sacramento Eye Consultants
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Danbury Eye Physicians and Surgeons, PC
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Hernando Eye Institute
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34615
Country
United States
Facility Name
Eye Associates of Fort Myers
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Shettle Eye Research
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
West Coast Eye Institute
City
Lecanto
State/Province
Florida
ZIP/Postal Code
34461
Country
United States
Facility Name
Clayton Eye Clinical Research, LLC
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Coastal Research Associates
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Kannarr Eye Care
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Heart of America Eye Care, P.A.
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Comprehensive Eye Care Ltd
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Wake Forest Health Network Ophthalmology- Oak Hollow
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Drs. Quinn, Foster & Associates
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Facility Name
Abrams Eye Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
Total Eye Care
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Eye Specialty Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Nashville Vision Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Texan Eye / Keystone Research, Ltd.
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Medical Center Ophth Assoc / Keystone Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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