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Completed

NCT Number: NCT04535947

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

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Orange County Ophthalmology Medical Group, Garden Grove, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vehicle

Drug

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.

SDP-4 Ophthalmic Solution (1.0%)

Drug

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 names: SDP-4 (1.0%)

Primary outcomes

  1. Symptom Assessment in Dry Eye (SANDE) Questionnaire

    Time frame: 56 days

    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 outcomes

  1. Corneal Fluorescein Staining

    Time frame: 56 days

    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.

  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

    Reported on a scale of 0-15 with values greater than 3 indicating abnormal incidence of conjunctival surface irregularity.

  4. Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Burning / Stinging)

    Time frame: 56 days

    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

  5. Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Discomfort)

    Time frame: 56 days

    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

  6. Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Dryness)

    Time frame: 56 days

    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

  7. Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Pain)

    Time frame: 56 days

    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

  8. Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Fluctuating Vision)

    Time frame: 56 days

    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

  9. Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Foreign Body Sensation)

    Time frame: 56 days

    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

  10. Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Itching)

    Time frame: 56 days

    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

  11. Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Photophobia)

    Time frame: 56 days

    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

Sponsors and collaborators

Lead sponsor

Silk Technologies, Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 2, 2020
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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