Clinical trial: A Study To Investigate The Effects Of A Low Humidity Environment And Visual Tasking On Tear Film Protein Composition (NCT02005874)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female, aged 18 or older in good general health on the basis of medical
             history and ophthalmic examination

          2. Subjects must have no known systemic disease or need for medication which may
             interfere with the study

          3. Subjects must have healthy eyes (no ophthalmic medication use nor current ocular
             infection) and concomitant medication may be permitted at the discretion of the
             investigator as long as there is no interference with study objectives or subject's
             safety.

          4. Subjects must have visual acuity best corrected to 20/50 or better for each eye with
             optometrist discretion for subjects with amblyopia.

          5. Subjects must be willing to discontinue their own contact lens wear for the period 7
             days before Screening Visit 1 through to the end of the study.

          6. Ability to comply with study protocol, provide written consent and complete study

             INCLUSION CRITERIA FOR THE MILD - MODERATE DRY EYE SUBJECTS WILL INCLUDE:

          7. OSDI questionnaire score of ≥15

          8. Ocular dryness score of >1 (0-4)

          9. TBUT <7 sec

         10. Biomicroscopic assessment of superficial punctate keratitis (SPK) of at least 1 in a
             scale of (0-4) indicative of dry eye syndrome over the 5 zone NEI cornea

             INCLUSION CRITERIA FOR THE NON-DRY EYE SUBJECTS WILL INCLUDE:

         11. OSDI questionnaire score <15

         12. TBUT ≥7 sec

         13. Biomicroscopic assessment reveals no SPK and good tear meniscus

         14. Ocular dryness score of 0 (0-4)

        Exclusion Criteria:

          1. Any ocular disease including keratoconus and Sjogren's syndrome

          2. Any tarsal abnormalities or corneal neovascularization >Grade2

          3. Ocular surgery including refractive surgery within the last 12 months

          4. Intraocular Pressure (IOP)>23mmHg and utilization of any prescribed ophthalmic
             medication

          5. Clinically significant disease or abnormality which the investigator may judge unsafe
             to participate in the study and/or interfere with the outcome of the study, including
             clinically significant physical findings on slitlamp examination or fundus evaluation.

          6. Pregnancy or breastfeeding, or plans to become pregnant or donate gametes (ova or
             sperm) for in vitro fertilization during the study period, or for 30 days following
             the study period.

          7. Subjects who require the use of antihistamines, corticosteroids or anti-glaucoma
             medications on a regular basis and who are unwilling to discontinue the use of these
             medications for appropriate periods prior to the study visits. (Section 4.3 Table 1:
             Prohibited Medication)

          8. Current participation in another clinical study involving an experimental treatment,
             or participation in such a study within 30 days prior to study entry.

          9. A known or suspected hypersensitivity, and/or contraindication to any of the
             ingredients of the investigational products.

         10. Not meeting concomitant medication washouts

         11. Inability to discontinue any ophthalmic eyedrops including OTC therapies.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


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? Contradiction