Phase 2
N=305
Study to Evaluate the Safety and Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED)
Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT03889886 ↗Enrolled (actual)
305
Serious AEs
0.3%
Results posted
Sep 2022
Primary outcome: Primary: Symptom Assessment in Dry Eye (SANDE) Questionnaire — -25.66; -25.14; -29.95; -24.81 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SDP-4 Ophthalmic Solution (0.1%) (Drug); SDP-4 Ophthalmic Solution (1.0%) (Drug); SDP-4 Ophthalmic Solution (3.0%) (Drug); Vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Silk Technologies, Ltd.
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Symptom Assessment in Dry Eye (SANDE) Questionnaire |
-25.66; -25.14; -29.95; -24.81 | — |
| SECONDARY Tear Breakup Time |
0.95; 1.29; 1.21; 0.80; 1.08; 1.15 | — |
| SECONDARY Anesthetized Schirmer's Test |
2.53; 2.95; 1.89; 3.75 | — |
| SECONDARY Conjunctival Hyperemia |
-0.6; -0.7; -0.9; -0.6; -0.6; -0.8 | — |
| SECONDARY Corneal Fluoroscein Staining |
-0.2; -1.4; -0.9; -1.4; -0.5; -1.2 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03889886). 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.