Clinical trial: Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort (NCT00349843)

Eligibility criteria:
Inclusion Criteria:

          1. Agrees to wear the study lenses on a daily wear basis without the use of ocular
             lubricants.

          2. Has an up to date pair of glasses and is willing to wear these glasses at different
             times during the study.

          3. Is correctable to a visual acuity of 6/6 or better with their habitual correction.

          4. Is willing and able to follow product usage instructions and maintain the visit
             schedule.

          5. Is at least 18 years of age and has full legal capacity to volunteer.

          6. Can be successfully fitted with study lens type.

          7. Has read, understood and signed an Information Consent Letter.

          8. Has a distance contact lens prescription is between -0.50 D and -9.00 D

          9. Has astigmatism of ≤ 1.00 D Cyl

         10. Has normal binocular vision, i.e. no strabismus, no amblyopia, and anisometropia of ≤
             1.00D

         11. Has no systemic disease affecting ocular health.

         12. Is not using any systemic or topical medications that will affect ocular health,
             accommodative function, or the ocular physiological response to the contact lenses.

         13. Has clear corneas and no active ocular disease.

         14. Has no known ocular or systemic allergies, which could interfere with contact lens
             wear.

         15. Has no lid or conjunctival abnormalities, neovascularization, limbal injection, bulbar
             injection or corneal staining, which in the investigator's opinion is clinically
             significant.

         16. Has not worn rigid contact lenses in the last 30 days or has corneal distortion
             resulting from rigid lens wear.

         17. Has not worn extended wear contact lenses in the last 30 days.

         18. Has had an oculo-visual examination in the last two years

        Exclusion Criteria:

          1. Has any active ocular disease.

          2. Has any lid or conjunctival abnormalities that may, in the opinion of the
             investigator, interfere with the wear of contact lenses.

          3. Has edema, staining, clinically significant corneal opacity, dystrophy,
             vascularization or iritis as viewed by slit lamp. (Trace or grade 1 equivalent limbal
             and bulbar injection or corneal staining is permissible at the discretion of the
             investigator.)

          4. Is using ocular lubricants or contact lens rewetting drops on a regular basis (at
             least once per day)

          5. Is using topical ocular prescription or any topical over-the-counter medication.

          6. Is actively involved in any other research/clinical study.

          7. Has worn rigid lenses or soft lenses on an extended wear basis within the last 30
             days.

          8. Has had corneal refractive surgery.

          9. Has known sensitivity to any of the study solutions.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 16 Years old.


Patient description (medical language): A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications.  Vital signs are normal.  On physical examination, the patient is tall with long upper extremities and fingers.  The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw.  The lungs are clear on auscultation.  The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver.

Patient description (patient's own words): I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since.

Does the patient match the trial criteria? Entailment