DAILIES TOTAL1 Versus ACUVUE TruEye - Effects on the Biology of the Ocular Surface and Lid Margin
Condition: Soft Contact Lenses; Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This is a prospective, single center, randomized, bilateral crossover, dispensing clinical
      trial to evaluate the effects of the water gradient lens, DAILIES TOTAL1, on the biology of
      corneal epithelium over two months of daily wear compared to wear of a control high oxygen
      permeable silicone hydrogel daily disposable contact lens, the ACUVUE TruEye; and to
      correlate these changes with alterations in the lid wiper, tear film and cellular changes at
      the limbus. The total proposed duration of this study is 12 months to ensure enrollment of up
      to 94 established contact lens wearers, with anticipated completion of 84. Data will be
      collected at baseline and following 2 months of daily wear for each lens type. Based upon
      data from the investigators previous contact lens clinical trials, a 1 month washout period
      is required prior to initiating lens wear and also between lens wear periods for the two
      types of lenses in order to eliminate any potential residual solution or lens effects on the
      corneal epithelium and restore homeostasis. The study is scheduled to commence upon
      Institutional Review Board approval.
    

Detailed description: 
      The following Standard of Care procedures will be performed during this study:

      I.Medical history and Concomitant Medication Recorded - Subjects will be interviewed about
      their demographics, medical and ocular History, and their allergies and medications. The
      study doctor or the study personnel will use paper source documents (Case Report Form) to
      collect and record the following data: current prescription of both contact lenses and
      glasses, refraction, and keratometry.

      II.Comprehensive Exam

      A. Snellen visual acuity testing (both eyes) This will be performed using a standard
      projector chart at twenty feet. All patients will be refracted to ensure that visual acuity
      and prescription are within the inclusion criteria.

      B. Anterior ocular segment inspection by slit lamp examination

        1. Blink rate is estimated per minute (both eyes)

        2. Normal eyelid and eyelash position is checked for both upper and lower lids (both eyes)

        3. The tear meniscus is inspected and estimated for height in millimeter and presence or
           absence of cells and debris including mucous threads (both eyes)

        4. The bulbar conjunctiva, cornea, anterior chamber, iris, and crystalline lens are
           inspected for any abnormalities (both eyes)

        5. Meibomian gland orifices are inspected for signs of inflammation or plugging; eyelid
           skin margin is inspected for inflammation and scaling (both eyes).

      C. Aqueous tear production (both eyes) Following application of 1 drop of topical tetracaine,
      Schirmer test strips are applied to the lower fornix at the outer one-third of the lower
      eyelid for 3 minutes and the length of wetting recorded in mm (≥ 3.0 mm wetting/3 minutes
      considered within normal limits).

      D. Corneal staining (both eyes) One-drop of non-preserved isotonic saline is placed upon the
      tip of a fluorescein test strip and applied to the lower fornix with the patient looking up;
      presence or absence of corneal staining with fluorescein is then noted by the screening
      clinician.

      E. Intraocular pressure measurement One drop of tetracaine is applied and the cornea is
      gently applanated with the tip of the Goldmann tonometer to ensure Intraocular pressure ≤ 21
      mmHg (both eyes).

      F. Evaluation of upper and lower eyelids Both upper eyelids are gently everted and both upper
      and lower conjunctival surfaces inspected for any abnormalities.

      G. Fundus examination The pupil is dilated OU (both eyes) with 1 drop each of 2.5%
      neosynephrine and 0.15% mydriacyl applied 1x, X2, or x3 as needed at 10 minute intervals to
      achieve >5 mm dilation OU. The fundus is then inspected for the appearance of the optic
      nerve, macula, retinal vessels and periphery and any abnormalities noted. Any abnormalities
      are cause for non-inclusion.

      The following Experimental Procedures will be performed:

      I. Informed Consent Process The research staff will review the study including the informed
      consent in detail and allow the subject time to make an informed decision. Following review
      and opportunity to ask questions, the subject will be asked to sign this consent form.

      II. Tear collection (both eyes) Tear collection will be performed as the first clinical test.
      Three µl sample volumes tears will be collected non-invasively in vivo using microcapillary
      tubes from the inferior tear meniscus at the temporal canthus of both eyes. Tears will be
      collected with the patient seated at the slit lamp with the light on low illumination.

      III. Corneal epithelial cell collection (left eye only) Corneal epithelial cells can be
      collected non-invasively in vivo using a custom-made ocular irrigation chamber specific for
      these types of studies. The corneal irrigation chamber collects corneal epithelial cells into
      a 15 ml test tube. The patient is seated with forehead resting against a headrest; a fixation
      target is placed to orient the eye to be irrigated downwards; and the irrigating tip is
      positioned 2 mm below the corneal apex. Irrigation involves the delivery of 9 ml of sterile
      saline to the central cornea for a period of 1 minute via a tubing pump.

      IV. In vivo confocal microscopy (right eye) A Heidelberg confocal microscope engineered in
      house with remote controlled scanning capabilities will be utilized in this study. One drop
      of topical tetracaine will be placed in the subject's eye; the subject's head is then placed
      in the headrest as for regular slit lamp examination. A drop of Genteal (Alcon Laboratories)
      is placed upon the top of the objective lens to serve as an immersion fluid. The cornea is
      then applanated using the standard objective lens tip. Both confocal microscopy through
      focusing scans and static images of the corneal epithelial surface will be acquired in the
      central cornea and all four quadrants of the limbus by controlling for the patient's
      direction of gaze. Similar image sequences will be performed to sequentially image the upper
      and lower lid wiper region at the midpoint of the eyelid (corresponding to the 5 and 7
      o'clock position of the limbus). For upper lid imaging, the lid will be everted prior to
      image acquisition. Sequential imaging will allow for subsequent montage generation of the
      mid-point of the upper and lower lid.

      Per visit details:

      Visit 1: Screening Visit - Comprehensive ocular examination (Contact Lens Clinic at UTSW)
      (This visit will last ~ 90 minutes)

        1. Informed Consent reviewed and signed

        2. Medical History and Concomitant Meds

        3. Comprehensive examination

        4. Back-up glasses ordered as needed

        5. Lens fitting and ordering based on randomization into the following lens groups:

           Alcon DAILIES TOTAL1 Johnson and Johnson ACUVUE TruEye

        6. One month washout begins

      Visit 2: Baseline Visit, lens 1 dispensed (This visit will last ~ 60 minutes)

        1. Brief screening exam (go over medical history, medications, and slit lamp exam)

        2. Informed consent re-reviewed

        3. Baseline biological indicators (outcome measures) assessed Tear collection OU (OU = both
           eyes) Lid wiper staining OD (OD = Right eye) Ocular irrigation (collect epithelial
           cells) OS (OS = Left eye) Confocal microscopy of cornea, limbus and lid margin OD

        4. Lenses dispensed

      Visit 3: 1 week of lens wear (+/- 3 days) (This visit will last ~ 30 minutes)

        1. Contact lens check up

             1. Lens fitting

             2. Slit lamp examination without corneal staining

      Visit 4: 2 month of lens wear (+/- 3 days) (This visit will last ~ 60 minutes)

        1. Brief screening exam (go over medical hx, medications, and slit lamp exam)

        2. Lenses and diaries collected

        3. Biological indicators assessed

      i. Lenses collected OU ii. Tear collection OU iii. Lid wiper staining OD iv. Ocular
      irrigation OS v. Confocal microscopy of cornea, limbus and lid margin OD d. Patient begins
      next 1 month washout period

      Visit 5: Baseline visit, lens 2 dispensed (This visit will last ~ 60 minutes) a. Brief
      screening exam (go over medical hx, medications, and slit lamp exam) b. Baseline biological
      indicators assessed i. Lenses collected OU ii. Tear collection OU iii. Lid wiper staining OD
      iv. Ocular irrigation OS v. Confocal microscopy of cornea, limbus and lid margin OD c. Lenses
      dispensed - begin crossover phase

      Visit 6: 1 week of lens wear (+/- 3 days) (This visit will last ~ 30 minutes)

      a. Contact lens check up

        1. Lens fitting

        2. Slit lamp examination without corneal staining

      Visit 7: 2 month of lens wear (+/- 3 days) (This visit will last ~ 60 minutes)

        1. Brief screening exam (go over medical hx, medications, and slit lamp exam)

        2. Lenses and diaries collected

        3. Biological indicators assessed

      i. Lenses collected OU ii. Tear collection OU iii. Lid wiper staining OD iv. Ocular
      irrigation OS v. Confocal microscopy of cornea, limbus and lid margin OD d. Study completed
    

Intervention name(s): Soft Contact Lens - Daily Disposable Alcon Dailies Total 1 and ACUVUE TruEye; Soft Contact Lens - Acuvue TruEye and Alcon DAILIES TOTAL 1.
Intervention type(s): Device; Device
Intervention description(s): Soft contact lens - Daily wear disposable lens to correct myopia in subjects who are nearsighted. Comparison of Alcon Dailies Total 1 versus Acuvue TruEye when worn as daily disposables over a two month period. This is a cross-over study where both brands of lenses will be worn by each participant over the course of the trial. Participants will be randomized for the order in which the two brands of lenses will be worn. There is a washout period of one month in between each 2 month contact lens wearing period.
In this experimental arm, Alcon Dailies Total 1 lenses will be worn first.; Soft contact lens - Daily wear disposable lens to correct myopia in subjects who are nearsighted. Comparison of Alcon Dailies Total 1 versus Acuvue TruEye when worn as daily disposables over a two month period. This is a cross-over study where both brands of lenses will be worn by each participant over the course of the study. Participants will be randomized for the order in which the two brands of lenses will be worn. There is a washout period of one month in between each 2 month contact lens wearing period.
In this active comparator arm, Acuvue TruEye lenses will be worn first.
Intervention MeSH terms: Dipivefrin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science