Phase 2
N=153
Study to Evaluate the Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED) (SDP-4-CS202)
Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT04535947 ↗Enrolled (actual)
153
Serious AEs
0.7%
Results posted
Sep 2022
Primary outcome: Primary: Symptom Assessment in Dry Eye (SANDE) Questionnaire — 58.95; 57.21; -18.80; -16.60 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vehicle (Drug); SDP-4 Ophthalmic Solution (1.0%) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Silk Technologies, Ltd.
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Symptom Assessment in Dry Eye (SANDE) Questionnaire |
58.95; 57.21; -18.80; -16.60 | — |
| SECONDARY Corneal Fluorescein Staining |
0.68; 0.74; -0.21; -0.04; -0.15; -0.22 | — |
| SECONDARY Tear Breakup Time |
3.75; 3.80; 1.06; 1.42; 2.00; 1.95 | — |
| SECONDARY Conjunctival Hyperemia |
0.80; 0.91; 0.00; 0.01; -0.07; -0.03 | — |
| SECONDARY Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Burning / Stinging) |
-7.89; -17.06 | — |
| SECONDARY Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Discomfort) |
-12.10; -13.18 | — |
| SECONDARY Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Dryness) |
-17.97; -18.38 | — |
| SECONDARY Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Eye Pain) |
-6.94; -6.47 | — |
| SECONDARY Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Fluctuating Vision) |
-6.17; -8.11 | — |
| SECONDARY Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Foreign Body Sensation) |
-6.94; -10.58 | — |
| SECONDARY Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Itching) |
-13.81; -9.75 | — |
| SECONDARY Individual Symptom Visual Analog Scale (VAS) Scores, Separately for Each Symptom (Photophobia) |
-12.69; -10.43 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04535947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.