Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)
Condition: Keratoconjunctivitis Sicca
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Keratoconjunctivitis
Intervention: Lotemax; Restasis; Soothe® Lubricant Eye Drops
Intervention description: Lotemax gel will be administered as per the dose and schedule specified in the arms.; Restasis emulsion will be administered as per the dose and schedule specified in the arms.
Intervention MeSH terms: Loteprednol Etabonate; Cyclosporine; Ophthalmic Solutions; Lubricant Eye Drops; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 102.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Dry Eye Disease

Summary:

      This study is being conducted to investigate the safety, comfort, and tolerability of 3
      treatments: loteprednol etabonate ophthalmic (Lotemax®) gel 0.5 percent (%) administered
      twice daily (BID) with or without cyclosporine ophthalmic emulsion (Restasis) 0.05%
      administered BID, and Restasis 0.05% treatment alone for 12 weeks and at a follow-up safety
      visit 1 week post-treatment. This study will also investigate the relative efficacy of
      Lotemax gel 0.5% administered BID with or without Restasis 0.05% treatment administered BID
      and of Restasis 0.05% treatment alone for the reduction of clinical signs or symptoms of
      keratoconjunctivitis sicca (DED) over the first 4 weeks of a 12-week treatment period and at
      the end of a 12-week treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been diagnosed with or treated for keratoconjunctivitis sicca (DED) within 6
             months prior to screening visit (Day -14).

          -  Have a baseline intraocular pressure (IOP) measurement of greater than or equal to (≥)
             5 millimeters of mercury (mmHg) and less than or equal to (≤) 22 mmHg in each eye,
             with or without anti-glaucoma therapy.

          -  Have mild to moderate DED in 1 eye or both eyes at screening visit (Day -14) and
             randomization visit (Day 0).

        Exclusion Criteria:

          -  Have a known hypersensitivity to corticosteroids, cyclosporine, fluorescein, lissamine
             green, topical anesthetic, or any component of either of the study drugs.

          -  Have severe DED.

          -  Have corneal erosive disease or other conditions suggestive of extensive damage of the
             cornea.

          -  Have a history of elevated IOP, a history of glaucoma, or IOP greater than (>) 22 mmHg
             in either eye at the screening visit (Day -14).

          -  Have had penetrating intraocular surgery in the past 12 months or require penetrating
             intraocular surgery during the study.

          -  Have had eyelid surgery within the 6 months prior to Visit 1 (Day -14) or have DED
             secondary to surgery.

          -  Have visible evidence of anterior lid Demodex spp. infection or infestation.

          -  Have had corneal refractive surgery or corneal transplantation.

          -  Have congenitally absent lacrimal or meibomian glands or have any obstructive disease
             of the lacrimal glands, sarcoidosis, or any other lacrimal gland deficiency.

          -  Have a diagnosis of on-going ocular infection, active anterior blepharitis, moderate
             to severe pinguecula, Stevens-Johnson syndrome, ocular cicatricial pemphigoid,
             significant conjunctival scarring, ocular chemical burn, or ocular neurotrophic
             keratitis.

          -  Have any serious systemic disease or uncontrolled medical condition that in the
             judgment of the investigator could confound study assessments or limit compliance.

          -  Have a history of ocular herpetic keratitis or have had active blepharitis in the 4
             weeks prior to the first dose.

          -  Have had ocular surgery (including laser) within 6 months prior to the first Treatment
             Period, or plan or require ocular surgery during the study. Neodymiumdoped:yttrium
             aluminum garnet (Nd:YAG) laser posterior capsulotomy is allowed.