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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: SDP-4 Ophthalmic Solution (0.1%) Drug: SDP-4 Ophthalmic Solution (1.0%) Drug: SDP-4 Ophthalmic Solution (3.0%) Drug: Vehicle Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 305 participants
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
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)
Actual Study Start Date : April 16, 2019
Actual Primary Completion Date : October 7, 2019
Actual Study Completion Date : October 11, 2019

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 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 Name: 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 Name: 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 Name: SDP-4 (3.0%)


Outcome Measures
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Primary Outcome Measures :
  1. Symptom Assessment in Dry Eye (SANDE) Questionnaire [ Time Frame: 84 days ]
    Mean change from baseline in total SANDE score at Visit 7/Day 84


Secondary Outcome Measures :
  1. Tear Breakup Time [ Time Frame: 84 days ]
    Mean change from baseline at each visit

  2. Anesthetized Schirmer's Test [ Time Frame: 84 days ]
    Mean change from baseline at each visit

  3. Conjunctival hyperemia and lissamine green staining measured by slit lamp [ Time Frame: 84 days ]
    Mean change from baseline at each visit

  4. Corneal fluoroscein staining [ Time Frame: 84 days ]
    Mean change from baseline at each visit


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 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
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): NCT03889886


Locations
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Sponsors and Collaborators
Silk Technologies, Ltd.
Investigators
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Study Director: Jamie Christensen Silk Technologies
More Information
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Responsible Party: Silk Technologies, Ltd.
ClinicalTrials.gov Identifier: NCT03889886    
Other Study ID Numbers: SDP-4-CS201
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 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
Pharmaceutical Solutions
Ophthalmic Solutions