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

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ClinicalTrials.gov Identifier: NCT04535947
Recruitment Status : Recruiting
First Posted : September 2, 2020
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Silk Technologies, Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Vehicle Drug: SDP-4 Ophthalmic Solution (1.0%) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized to either 1% SDP-4 ophthalmic solution or vehicle in 1:1 ratio in parallel groups.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Treatment
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)
Actual Study Start Date : August 14, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Vehicle
Vehicle
 Drug: Vehicle
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.
Experimental: SDP-4 Ophthalmic Solution (1.0%)
Active
 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 8 weeks (56 days). Both eyes will be treated.
Other Name: SDP-4 (1.0%)


Outcome Measures
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Primary Outcome Measures :
  1. Symptom Assessment in Dry Eye (SANDE) Questionnaire [ Time Frame: 56 days ]
    Mean change from baseline in total SANDE at Visit 5/Day 56


Secondary Outcome Measures :
  1. Corneal fluorescein staining [ Time Frame: 56 days ]
    Mean and mean change from baseline at each visit

  2. Tear Breakup Time [ Time Frame: 56 days ]
    Mean and mean change from baseline at each visit

  3. Conjunctival hyperemia [ Time Frame: 56 days ]
    Mean and mean change from baseline at each visit

  4. Individual symptom Visual Analog Scale (VAS) scores, separately for each symptom [ Time Frame: 56 days ]
    Mean and mean change from baseline at each visit as measured on a scale from 0 to 100, where higher scores indicate a worse outcome


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04535947


Contacts
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Contact: Nick Paulson 763-463-9316 nickpaulson@silk-tech.com

Locations
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United States, California
Orange County Ophthalmology Medical Group Recruiting
Garden Grove, California, United States, 92843
LoBue Laser and Eye Medical Center Recruiting
Murrieta, California, United States, 92562
Eye Research Foundation Recruiting
Newport Beach, California, United States, 92663
United States, Missouri
Ophthalmology Associates Recruiting
Saint Louis, Missouri, United States, 63131
United States, Tennessee
Total Eye Care Recruiting
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Silk Technologies, Ltd.
More Information
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Responsible Party: Silk Technologies, Ltd.
ClinicalTrials.gov Identifier: NCT04535947    
Other Study ID Numbers: SDP-4-CS202
First Posted: September 2, 2020    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
 Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions