Clinical trial: Non-invasive Ocular Surface Measurements Before and After Interventions (NCT01228929)

Eligibility criteria:
Inclusion Criteria:

          -  Individuals with dry eye diagnoses (aqueous deficient dry eye [ADDE], and/or
             evaporative dry eye), dry eye symptoms (as associated with Sjogren's Syndrome
             diagnosis), refractive surgery, contact lens use, and exposure to dry work
             environments are appropriate to correlate clinical tests, subjective responses and
             objective measurements of current ocular surface status and to study
             clinically-recommended or patient-directed dry eye treatments such as taking dietary
             supplements, wearing moisture-retaining goggles, performing lid massage, or using over
             the counter eye drops or artificial tears.

          -  Individuals who do not currently have dry eye symptoms but who may be at risk for dry
             eye diagnosis, and those who have dry eye symptoms but no clinical dry eye diagnosis,
             are of interest to correlate clinical tests, subjective responses and objective
             measurements of current ocular surface status and, if symptoms appear or worsen, to
             correlate the data with the effect of environmental condition changes, such as
             increasing the humidity or reducing air flow, on the ocular surface.

          -  Individuals who have undergone ocular surgery are at increased risk for dry eye. While
             some subjects who have had ocular surgery may never develop dry eye symptoms because
             they have an adequate reserve of tear production, others may develop symptoms as a
             result of the disruption of the ocular surface, including the anatomy and nerves.
             Subjects who have had surgery or procedures and are no longer being provided with
             direct post-operative care may participate in the study. Routine follow-up post-
             operative care does not disqualify subjects from participation. Subjects who are
             receiving post-operative care must obtain approval of their clinician to participate
             in the study.

          -  Individuals who have eye conditions that affect the shape or condition of the cornea,
             such as individuals with keratoconus.

          -  Experienced contact lens wearers are appropriate for studies that use their own lenses
             (soft, rigid gas permeable [RGP], hard [PMMA]) or the same type of lens within the FDA
             approved modality (daily, continuous or extended wear) and replacement cycle (for
             example, daily, one week, one month, etc.) as described in the lens package insert
             and/or prescribed by their eye care provider to investigate ocular surface data
             before, during and after lens use.

          -  Normal individuals, those without a dry eye diagnosis, without dry eye symptoms or
             those who do not wear contacts to act as controls for the focus areas in the studies.

        Exclusion Criteria:

        Individuals with eye or medical condition(s) that contraindicate performing screening or
        measurements will not be eligible for this study. Specific examples include:

          -  Individuals will not be dilated if an exam and/or medical history indicted they have a
             narrow anterior chamber angle, glaucoma, or other contraindications to dilation (like
             arterio-sclerotic cerebrovascular disease).

          -  Individuals with the following will not participate in contact lens studies: presence
             of ocular or systemic allergies or disease (infection), clinically significant (grade
             3 or 4) corneal edema, corneal vascularization, or any other abnormalities of the
             cornea, tarsal abnormalities or bulbar injection or use of medication that might
             interfere with contact lens wear.

          -  Individuals will not participate in any aspect of the study if: they are pregnant or
             become pregnant or are lactating, have an infectious disease (e.g. hepatitis,
             tuberculosis) or have an immuno-suppressive disease (e.g. HIV).

          -  Individuals with known sensitivity to dyes or to numbing drops will not be screened
             using these agents.

          -  Individuals who wear dental braces cannot be involved in the measurements in which a
             dental impression/bite bar is required. The impression material will stick to the
             braces. Individuals with very sensitive teeth or loose dentures may have difficulty
             making the dental impression.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 89 Years

Patient description (medical language): A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn.  The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness.  She also reports occasional joint pain.  Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease.  She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h)

Patient description (patient's own words): I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR.

Does the patient match the trial criteria? 1