Study to Evaluate the Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED) (SDP-4-CS202)
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: Vehicle; SDP-4 Ophthalmic Solution (1.0%)
Intervention description: 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.; 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.
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized to either 1% SDP-4 ophthalmic solution or vehicle in 1:1 ratio in parallel groups.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: All investigation product (1% SDP-4 ophthalmic solution and vehicle) will be provided in single-use doses (SUDs) contained in foil pouches.
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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