Direct Application of Systane Complete to Contact Lenses
Condition: Dry Eye; Contact Lens Complication
MeSH terms: Dry Eye Syndromes
Intervention: Systane Complete; Sensitive Eyes Rewetting Drops
Intervention description: Systane Complete is an artificial tear.; Sensitive Eyes Rewetting Drops is a rewetting drop.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Investigator Masked, Randomized, Clinical Trial
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking description: The investigator will be masked to the subject's treatment. The subjects cannot be fully masked because there is a no treatment control group.
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Systane Complete; Dry Eye; Contact Lens Discomfort; Artificial Tears; Rewetting Drops

Summary:

      A common first line treatment for patients with dryness symptoms or contact lens discomfort
      is the application of artificial tears or rewetting drops, respectively. Rewetting drops are
      specifically formulated for use with contact lenses while artificial tears are indicated for
      dry eye. Modern rewetting drops and artificial tears have similar formulations with similar
      preservatives, preservatives that have been shown to be compatible with contact lenses. While
      rewetting drops and artificial tears are regulated under different U.S. Food & Drug
      Administration policies, artificial tears are not specifically indicated for direct use with
      contact lenses. Nevertheless, clinicians commonly prescribe artificial tears to contact lens
      wearers likely because newer formulations of artificial tear have the potential to outperform
      available rewetting drops. The safety and efficacy of using artificial tears with contact
      lenses for the treatment of discomfort is supported by Caffery and Josephson and Ozkan and
      Papas who found that artificial tears significantly reduces dryness symptoms in contact lens
      wearers. Thus, the purpose of this study is to test the safety of directly applying a new
      artificial tear, Systane Complete, to the contact lens wearing eye and its ability to
      alleviate symptoms while wearing contact lenses during the day.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Daily disposable contact lens wearers

          -  20/30 visual acuity or better

          -  Self-report contact lens discomfort

          -  Contact Lens Dry Eye Questionnaire (CLDEQ)-8 scores ≥ 12

        Exclusion Criteria:

          -  Other contact lens modalities/wear schedules (e.g., two week and monthly replacement
             CLs, gas permeable CLs)

          -  Non-compliant daily disposable contact lens wearers

          -  Systemic health conditions that alter tear film physiology (e.g., primary and
             secondary Sjögren's syndrome)

          -  History of ocular surgery within the past 12 months

          -  History of severe ocular trauma

          -  History of active ocular infection or inflammation

          -  Isotretinoin-derivatives use

          -  Ocular medication use

          -  Pregnant or breast feeding