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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: SDP-4 Ophthalmic Solution (0.1%)
* Drug: SDP-4 Ophthalmic Solution (1.0%)
* Drug: SDP-4 Ophthalmic Solution (3.0%)
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vehicle<br>Vehicle | Drug: Vehicle<br>* 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.<br>|
| Experimental: SDP-4 Ophthalmic Solution (0.1%)<br>Low concentration of SDP-4 | Drug: SDP-4 Ophthalmic Solution (0.1%)<br>* 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.<br>* Other names: SDP-4 (0.1%);|
| Experimental: SDP-4 Ophthalmic Solution (1.0%)<br>Mid concentration of SDP-4 | Drug: SDP-4 Ophthalmic Solution (1.0%)<br>* 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.<br>* Other names: SDP-4 (1.0%);|
| Experimental: SDP-4 Ophthalmic Solution (3.0%)<br>High concentration of SDP-4 | Drug: SDP-4 Ophthalmic Solution (3.0%)<br>* 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.<br>* Other names: SDP-4 (3.0%);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Assessment in Dry Eye (SANDE) Questionnaire | 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. | 84 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Breakup Time | Mean change from baseline at each visit | 84 days | 
| Anesthetized Schirmer's Test | Mean change from baseline at Visit7/Day 84 | 84 days | 
| Conjunctival Hyperemia | 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. | 84 days | 
| Corneal Fluoroscein Staining | 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. | 84 days |