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

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ClinicalTrials.gov Identifier: NCT03889886
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Silk Technologies, Ltd.

Tracking Information
First Submitted Date  ICMJE March 22, 2019
First Posted Date  ICMJE March 26, 2019
Last Update Posted Date August 28, 2020
Actual Study Start Date  ICMJE April 16, 2019
Actual Primary Completion Date October 7, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
Symptom Assessment in Dry Eye (SANDE) Questionnaire [ Time Frame: 84 days ]
Mean change from baseline in total SANDE score at Visit 7/Day 84
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2019)
  • Tear Breakup Time [ Time Frame: 84 days ]
    Mean change from baseline at each visit
  • Anesthetized Schirmer's Test [ Time Frame: 84 days ]
    Mean change from baseline at each visit
  • Conjunctival hyperemia and lissamine green staining measured by slit lamp [ Time Frame: 84 days ]
    Mean change from baseline at each visit
  • Corneal fluoroscein staining [ Time Frame: 84 days ]
    Mean change from baseline at each visit
Original Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
  • Tear Breakup Time [ Time Frame: 84 days ]
    mean change from baseline at each visit
  • Anesthetized Schirmer's Test [ Time Frame: 84 days ]
    mean change from baseline at each visit
  • Conunctival hyperemia and lissamine green staining measured by slit lamp [ Time Frame: 84 days ]
    mean change from baseline at each visit
  • Corneal fluoroscein staining [ Time Frame: 84 days ]
    mean change from baseline at each visit
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED)
Official Title  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
All investigational product (SDP-4 concentrations and vehicle) will be provided in single-use doses (SUDs) contained in foil pouches.
Primary Purpose: Treatment
Condition  ICMJE Dry Eye
Intervention  ICMJE
  • 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 Name: SDP-4 (0.1%)
  • 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 Name: SDP-4 (1.0%)
  • 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 Name: SDP-4 (3.0%)
  • 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.
Study Arms  ICMJE
  • Placebo Comparator: Vehicle
    Vehicle
    Intervention: Drug: Vehicle
  • Experimental: SDP-4 Ophthalmic Solution (0.1%)
    Low concentration of SDP-4
    Intervention: Drug: SDP-4 Ophthalmic Solution (0.1%)
  • Experimental: SDP-4 Ophthalmic Solution (1.0%)
    Mid concentration of SDP-4
    Intervention: Drug: SDP-4 Ophthalmic Solution (1.0%)
  • Experimental: SDP-4 Ophthalmic Solution (3.0%)
    High concentration of SDP-4
    Intervention: Drug: SDP-4 Ophthalmic Solution (3.0%)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2020)
305
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2019)
300
Actual Study Completion Date  ICMJE October 11, 2019
Actual Primary Completion Date October 7, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03889886
Other Study ID Numbers  ICMJE SDP-4-CS201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Silk Technologies, Ltd.
Study Sponsor  ICMJE Silk Technologies, Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jamie Christensen Silk Technologies
PRS Account Silk Technologies, Ltd.
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP