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Study to Evaluate the Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED) (SDP-4-CS202)

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vehicle
SDP-4 Ophthalmic Solution (1.0%)
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, as supported by a subject-reported history of daily symptoms of dryeye for ≥ 6 months prior to Visit 1/Screening requiring the use of artificial tears.
  • Total score ≥ 40 and ≤ 70 on the SANDE questionnaire at Visits 1 and 2.
  • Tear break-up time (TBUT) of ≤ 6 seconds in both eyes at Visits 1 and 2.
  • Anesthetized Schirmer's test tear volume ≥ 3 mm and <10 mm in both eyes (only at Visit 1).
  • Best-corrected visual acuity (BCVA) of +0.7 logMAR or better in each eye as assessed by logMAR chart at Visits 1 and 2.

Exclusion Criteria:

  • Ocular surface corneal disease other than DED.
  • Diagnosis of Sjögren's disease.
  • Lid margin disorder other than meibomian gland dysfunction (MGD)
  • Presence of any ocular condition (e.g., pterygium) that in the Investigator's opinion could affect study parameters.
  • Any previous reconstructive or cosmetic eyelid surgery
  • 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.
  • Cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal within 30 days prior to Visit 1/Screening or planned during the study.
  • Contact lens wear.
  • 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

  • Orange County Ophthalmology Medical Group
  • LoBue Laser and Eye Medical Center
  • Eye Research Foundation
  • Ophthalmology Associates
  • Total Eye Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Vehicle

SDP-4 Ophthalmic Solution (1.0%)

Arm Description

Vehicle

Active

Outcomes

Primary Outcome Measures

Symptom Assessment in Dry Eye (SANDE) Questionnaire
Mean change from baseline in total SANDE at Visit 5/Day 56 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

Corneal Fluorescein Staining
Mean and 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.
Tear Breakup Time
Mean and mean change from baseline at each visit
Conjunctival Hyperemia
Mean and 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.
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Burning / Stinging)
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Discomfort)
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Dryness)
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Pain)
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Fluctuating Vision)
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Foreign Body Sensation)
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Itching)
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Photophobia)
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome

Full Information

First Posted
August 27, 2020
Last Updated
August 11, 2022
Sponsor
Silk Technologies, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04535947
Brief Title
Study to Evaluate the Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED) (SDP-4-CS202)
Official Title
A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel Group, Study of SDP-4 Ophthalmic Solution in Subjects With Dry Eye Disease (DED)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 14, 2020 (Actual)
Primary Completion Date
February 10, 2021 (Actual)
Study Completion Date
February 10, 2021 (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-CS202 is a Phase 2, multicenter, double-masked, randomized, vehicle-controlled, parallel group study designed to evaluate the ocular efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease over an 8-week treatment period. Once concentration (1%) of SDP-4 ophthalmic solution will be given in a parallel group to vehicle 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 either 1% SDP-4 ophthalmic solution or vehicle in 1:1 ratio in parallel groups.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All investigation product (1% SDP-4 ophthalmic solution and vehicle) will be provided in single-use doses (SUDs) contained in foil pouches.
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle
Arm Title
SDP-4 Ophthalmic Solution (1.0%)
Arm Type
Experimental
Arm Description
Active
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 8 weeks (56 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 8 weeks (56 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 at Visit 5/Day 56 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
56 days
Secondary Outcome Measure Information:
Title
Corneal Fluorescein Staining
Description
Mean and 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
56 days
Title
Tear Breakup Time
Description
Mean and mean change from baseline at each visit
Time Frame
56 days
Title
Conjunctival Hyperemia
Description
Mean and 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
56 days
Title
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Burning / Stinging)
Description
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Time Frame
56 days
Title
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Discomfort)
Description
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Time Frame
56 days
Title
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Dryness)
Description
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Time Frame
56 days
Title
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Pain)
Description
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Time Frame
56 days
Title
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Fluctuating Vision)
Description
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Time Frame
56 days
Title
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Foreign Body Sensation)
Description
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Time Frame
56 days
Title
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Itching)
Description
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Time Frame
56 days
Title
Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Photophobia)
Description
Mean and mean change from baseline at final visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome
Time Frame
56 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, as supported by a subject-reported history of daily symptoms of dryeye for ≥ 6 months prior to Visit 1/Screening requiring the use of artificial tears. Total score ≥ 40 and ≤ 70 on the SANDE questionnaire at Visits 1 and 2. Tear break-up time (TBUT) of ≤ 6 seconds in both eyes at Visits 1 and 2. Anesthetized Schirmer's test tear volume ≥ 3 mm and <10 mm in both eyes (only at Visit 1). Best-corrected visual acuity (BCVA) of +0.7 logMAR or better in each eye as assessed by logMAR chart at Visits 1 and 2. Exclusion Criteria: Ocular surface corneal disease other than DED. Diagnosis of Sjögren's disease. Lid margin disorder other than meibomian gland dysfunction (MGD) Presence of any ocular condition (e.g., pterygium) that in the Investigator's opinion could affect study parameters. Any previous reconstructive or cosmetic eyelid surgery 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. Cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal within 30 days prior to Visit 1/Screening or planned during the study. Contact lens wear. 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
Facility Information:
Facility Name
Orange County Ophthalmology Medical Group
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
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
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Total Eye Care
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study to Evaluate the Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED) (SDP-4-CS202)

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