Effects of Systane Versus Saline in Maintaining Tear Film Stability at Determined Time Points
Condition: Keratoconjunctivitis Sicca
MeSH terms: Keratoconjunctivitis; Keratoconjunctivitis Sicca; Dry Eye Syndromes
Study type: Interventional

Summary: 
      To evaluate tear film stability of a market lubricant therapeutic eye drop versus saline when
      using Evaporometry and Interferometry in patients with a diagnosis of Keratoconjunctivitis
      Sicca (KCS). The purpose of this research is to evaluate evaporative parameters and tear film
      quality when using Systane lubricating eye drops versus saline in the eyes of dry eye
      patients at pre-instillation and at 30 and 60 minutes post instillation of drop(s).
    

Detailed description: 
      The goal of this research is to evaluate and compare the effectiveness of Systane® versus
      saline on aqueous tear film stability in patients with a diagnosis of Dry Eye Syndrome and to
      determine the possible application for this product in the future. Systane® is marketed as
      over-the-counter tear lubricating therapy in the United States under the FDA monograph.

      Twelve (12) patients will be enrolled in this two-period crossover, randomized study design.
      During the course of the study, each patient will be treated with each test articles in the
      clinic at separate visits. Following the informed consent procedure, a general ocular
      evaluation, including corneal and conjunctival staining, Schirmer testing, evaporometry, and
      interferometry assessments will be completed to determine baseline tear evaporation rate.
      This will occur before any test article is administered to the patient.

      Qualified patients will be randomized into two treatment groups. After 1 hour, in order to
      eliminate any residual sodium fluorescein, patients will be administered one drop of Systane®
      (40 µl) or saline (40 µl) in each eye per randomization assignment. At 30 and 60 minutes
      following instillation of drop, evaporometry and interferometry measurements will be repeated
      again. These tests (pre and post instillation of drops) will be performed in order to
      establish a comparison for later analysis. The estimated time in completing these visits will
      be 180 minutes per visit. Patients will be asked to return to the clinic after 2 - 14 days
      for evaluation of the 2nd assigned treatment.

      During the interim study periods, patients will be asked to continue their pre-study routine;
      using their pre-study ocular lubricant or other tear products at the same frequency. Any
      changes in the frequency of product use during the interim period or any changes in other
      concomitant medications will be carefully recorded. This is especially important since many
      prescription products (e.g., Claritan) have significant effects on lacrimal gland physiology.

      An effort will be made to schedule all study visits at approximately the same time of day in
      order to reduce diurnal variability. For the similar reasons, all patients will be asked not
      to use any lubricants or ocular medications within one hour of their office visits.
    

Intervention name(s): Systane Ocular Drops (OTC); Placebo - Saline Drops
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Blepharitis