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Completed

NCT Number: NCT03889886

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

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.

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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

Canyon City Eyecare, Azusa, 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 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

Treatment and study plan

SDP-4 Ophthalmic Solution (0.1%)

Drug

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 names: SDP-4 (0.1%)

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 12 weeks (84 days). Both eyes will be treated.

Other names: SDP-4 (1.0%)

SDP-4 Ophthalmic Solution (3.0%)

Drug

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 names: SDP-4 (3.0%)

Vehicle

Drug

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.

Primary outcomes

  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

    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. 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 Visit7/Day 84

  3. Conjunctival Hyperemia

    Time frame: 84 days

    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. Corneal Fluoroscein Staining

    Time frame: 84 days

    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.

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, Dose-Response Study of SDP-4 Ophthalmic Solution in Subjects With Dry Eye Disease (DED)

Acronym: SDP-4-CS201

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 26, 2019
Registry last updated
Sep 2, 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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