Clinical trial: Study to Evaluate the Clinical Performance of SynergEyes A2 Hybrid Contact Lenses (NCT01058629)

Eligibility criteria:
Inclusion Criteria:

          -  Be able to understand and be willing to sign a written informed consent form

          -  Age ≥18 years

          -  Be willing and able to adhere to the instructions set forth in this protocol and able
             to keep all specific appointments

          -  Have naturally occurring myopia up to -6.00 D or hyperopia up to +2.00 D (spectacle
             plane) with or without corneal astigmatism up to 6.00 D

          -  Be in good general health, based on his/her knowledge, including normal healthy eyes

          -  Possess wearable and visually functional eyeglasses

          -  Have manifest refraction visual acuity equal to or better than 20/25 in each eye

        Exclusion Criteria:

          -  Subject requires multifocal vision correction or is wearing lenses in a monovision
             modality

          -  Subject has lenticular astigmatism uncorrectable by normal RGP tear layer optics

          -  Subject exhibits poor personal hygiene

          -  Subject is currently or within 30 days prior to enrollment in this study has been an
             active participant in another clinical study (except SynergEyes Protocol # SI 08-05)

          -  Subject is currently pregnant (to the best of the subject's knowledge), is planning a
             pregnancy within the next 9 months, or is lactating

          -  Subject has a known sensitivity to ingredients used in contact lens care products

          -  Subject has undergone refractive surgery or is currently receiving or has previously
             received orthokeratology treatment

          -  Subject is aphakic or pseudophakic

          -  Subject has ocular or systemic disease such as, but not limited to, anterior uveitis
             or iritis (past or present), glaucoma, Sjogren's Syndrome, lupus erythematosus,
             scleroderma, keratoconus, post surgical corneal irregularity or type II diabetes

          -  Subject is using ocular medications for any reason or systemic medications which might
             interfere with contact lens wear

          -  A known history of corneal hypoesthesia (reduced corneal sensitivity)

          -  Slit lamp findings that would contraindicate contact lens wear, including, but not
             limited to:

               -  Evidence of corneal ulcer, corneal infiltrates or fungal infections

               -  Corneal scars within the visual axis

               -  Pterygium

               -  Dry eye symptoms with decrease tear levels and punctuate staining ≥ Grade 2

               -  Neovascularization or ghost vessels ≥1.5mm in from the limbus

               -  Seborrhoeic eczema or seborrhoeic conjunctivitis

               -  History of papillary conjunctivitis that has interfered with lens wear or a
                  current condition of Grade 2 or greater

          -  Clinically significant (Grade 3 or 4) anterior segment abnormalities or any infection
             of the eye, lids or associated structures
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 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