A Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: 0.25% Tanfanercept Ophthalmic Solution; Placebo
Intervention description: Tanfanercept ophthalmic solution.; Placebo vehicle solution.
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study was to compare the safety and efficacy of tanfanercept ophthalmic
      solution 0.25% with placebo for the treatment of the signs and symptoms of dry eye.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a participant-reported history of dry eye for at least 6 months prior to Visit 1

          -  Have a history of use or desire to use eye drops for dry eye symptoms within 6 months
             of Visit 1

          -  Have a best-corrected visual acuity (BCVA) of 0.7 minimum angle of resolution (logMAR)
             or better (Snellen equivalent score of 20/100 or better) in each eye at Visit 1

          -  Report a score of ≥ 2 according to the Ora Calibra® ocular discomfort & 4-symptom
             questionnaire in at least one of the dry eye symptoms at Visits 1 and 2

          -  Have a Schirmer's Test score of ≤ 10 millimeter (mm) and ≥ 1 mm in at least one eye at
             Visits 1 and 2

          -  Have a corneal fluorescein staining score ≥ 2 according to the Ora Calibra® corneal
             and conjunctival staining scale for grading of fluorescein staining in at least 1 of
             the corneal regions (inferior, superior, or central) in at least 1 eye at Visits 1 and
             2

          -  Have a conjunctival redness score ≥ 1 according to the Ora Calibra® conjunctival
             redness for dry eye scale in at least 1 eye at Visits 1 and 2

        Exclusion Criteria:

          -  Have any clinically significant slit lamp findings at Visit 1 that may include active
             blepharitis, meibomian gland dysfunction, lid margin inflammation or active ocular
             allergies that require therapeutic treatment, and/or in the opinion of the
             investigator may interfere with study parameters

          -  Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active
             ocular inflammation at Visit 1

          -  Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses
             during the study

          -  Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the
             last 12 months

          -  Have used any cyclosporine-containing drops (such as Restasis®, Cequa®), or
             lifitegrast ophthalmic solution (Xiidra®) within 60 days of Visit 1

          -  Have any previous experience using TNF inhibitor ophthalmic solutions, such
             Tanfanercept Ophthalmic Solution

          -  Be currently taking any topical ophthalmic prescription (including medications for
             glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and
             cannot discontinue these medications for the duration of the trial (excluding
             medications allowed for the conduct of the study)

          -  Be a woman who is pregnant, nursing or planning a pregnancy