Effects of Dry Eye Treatments on the Ocular Surface
Condition: Keratoconjunctivitis Sicca; Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratoconjunctivitis
Intervention: Dexamethasone; Artificial tear
Intervention MeSH terms: Dexamethasone; Lubricant Eye Drops
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Vehicle and therapy groups were not masked.
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate whether, in people with dry eye syndrome, over the
      counter artificial tears and the prescription eye drop, dexamethasone, change or effect the
      eyes response to a low humidity environment.

      It is known that irritation from dry eye can be improved by over the counter artificial tears
      because they wet and lubricate the eyes. The prescription eye drop, dexamethasone, can also
      improve eye irritation by decreasing the inflammation that develops in dry eye. Thus, the
      investigators hypothesize that the use of these conventional dry eye treatments will improve
      the eyes' response to a low humidity environment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signature on the written informed consent form

          -  Patient motivation and willingness to cooperate with the investigator by following the
             required medication regimen

          -  Patient willingness and ability to return for all visits during the study

          -  Rapid tear film break up time of seven seconds or less in at least one eye AND

          -  Both cornea fluorescein staining score 3 or greater and conjunctival lissamine green
             staining 3 or greater in at least one eye

          -  Ocular Surface Disease Index Symptom Severity score of twenty or greater

          -  Tear meniscus height less than or equal to 200um

          -  Intact corneal sensitivity

          -  Willingness to discontinue use of any current dry eye treatment (except artificial
             tears) for four weeks prior to enrollment, and during the course of the study

        Exclusion Criteria:

          -  Compromised cognitive ability which may be expected to interfere with study compliance

          -  Uncontrolled or poorly controlled diabetes or heart or pulmonary disease that could,
             in the judgment of the investigator, jeopardize subject safety or interfere with the
             interpretation of the results of the study

          -  Known hypersensitivity to any components of the artificial tears or dexamethasone eye
             drops

          -  Anticipated contact lens wear during the study

          -  History of corneal transplant

          -  Active ocular infection, uveitis or non-Keratoconjunctivitis sicca related
             inflammation

          -  History of cataract surgery within 3 months prior to enrollment

          -  History of pterygium removal within 6 months prior to enrollment

          -  Reduced corneal sensitivity

          -  Initiation, discontinuation or change in dosage of hormone replacement therapy, fish
             oil, evening primrose, flaxseed, or black current seed oil supplements,
             antihistamines, cholinergic agents, beta-blocking agents, tricyclic or selective
             serotonin reuptake inhibitors, antidepressants, phenothiazines, or topical or systemic
             acne rosacea medications in two months prior to enrollment, or anticipated change in
             dosage during course of study

          -  Topical ophthalmic medications within prior 4 weeks, or anticipated use of same during
             the study (except artificial tears)

          -  Occlusion of the lacrimal puncta either surgically or with temporary collagen punctal
             plugs within three months prior to study, or anticipated use of same during study