Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 12-month Prospective Study of Tear Osmolarity in Contact Lens Wearers Refitted With Daily Disposable Soft Contact Lenses
Brief Summary: Tear osmolarity refers to the amount of osmotically active particles in tears and has been reported as one of the best diagnostic test for dry eye disease. Our research focused on following changes in tear osmolarity and ocular symptoms in the time-course of one year after refitting habitual contact lens wearers or fitting novices with modern daily disposable soft contact lenses. Fifty-six contact lens wearers aged (mean ± standards deviation) 26 ± 4 y/o were refitted with Silicone-Hydrogel (Delefilcon A) or Hydrogel (Omafilcon A) lenses.

Study included seven visits: baseline measurement before the study, two visits for contact lens fit and control and follow-up measurements after three, six, and 12 months of contact lens wear followed by measurements on bare eye according to the baseline scheme (post-study visit).

An impedance-based osmometer was used to collect samples from the lower tear meniscus. A standard Ocular Surface Disease Index (OSDI) questionnaire was used to monitor subject-reported ocular symptoms. Statistically significant differences were noted in tear osmolarity in the time course of the study for both eyes.

An improvement in tear osmolarity was most prevalent among subjects with high initial tear osmolarity. Low osmolarity levels were maintained after the study.

The findings of this prospective study will reveal that habitual contact lens wearers or novices may benefit from refitting with modern daily disposable soft contact lenses.


Options:
A: Inclusion Criteria:

* Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent
* Be at least 18 years old, male or female
* Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator
* Have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses
* Correctable to at least 6/12 (20/40) or better in each eye with contact lenses
* Be willing to not wear contact lenses for a minimum of 2 days before each stage of the clinical trial (after informed consent)

Exclusion Criteria:

* Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses
* Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants
* Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial
* Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used
* Eye surgery within 12 weeks immediately prior to enrolment for this trial.
* Previous corneal refractive surgery
* Contraindications to contact lens wear
* Known allergy or intolerance to ingredients in any of the clinical trial products

The Investigator may, at his/her discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant's best interests
B: Inclusion Criteria:

* Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
* Be at least 18 years old, male or female.
* Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
* Have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses.
* Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses.
* Be suitable and willing to wear contact lenses.

Exclusion Criteria:

* Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses.
* Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
* Use of or a need for concurrent category S3 and above ocular medication at enrolment. Ocular medication can be prescribed during the course of the trial as per standard optometric practice.
* Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial. Note: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.
* Eye surgery within 12 weeks immediately prior to enrolment for this trial.
* Previous corneal refractive surgery.
* Contraindications to contact lens wear.
* Known allergy or intolerance to ingredients in any of the clinical trial products.
C: Inclusion Criteria:

1. The patient must be at least 15 years old.
2. The patient must be free of any anterior segment disorders.
3. The patient must have a spectacle corrected spherical refractive error between +5.50 D and -11.00 D with less than or equal to 1.00 D refractive cylinder.
4. The patient must be correctable to 20/25 or better with spectacles.
5. Flat and steep corneal curvatures from Simulated Keratometry readings must be between 39.00 and 48.00 D.
6. Can be successfully fit with lotrafilcon A lenses at the enrollment visit.

Exclusion Criteria

1. The patient has worn rigid gas permeable lenses within the last 30 days or polymethylmethacrylate lenses within the last 3 months.
2. The patient must not be a current successful daily wear user of lotrafilcon A lenses. They may have tried lotrafilcon A lenses in the past, but must not have successfully worn these lenses for daily wear within the last 12 months.
3. The patient has an autoimmune disease (except for Hashimoto's Thyroiditis), immunocompromising disease, connective tissue disease, atopic dermatitis, insulin dependent diabetes, or any other systemic disease that in the investigator's opinion will affect ocular health.
4. The patient is taking chronic systemic medications such as corticosteroids, antimetabolites, or non-steroidal anti-inflammatory agents or any other medication that in the investigator's opinion will affect ocular physiology or study participation.
5. The patient has any ocular disease or condition such as aphakia, corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery.
6. The patient is taking any ocular medications. If a patient was previously taking any ocular medications, the medications must have been discontinued at least 2 weeks prior to enrollment.
7. The patient must have less than or equal to grade 2 on any of the slit lamp observations of: upper tarsal papilla, corneal staining, corneal neovascularization, conjunctival injection, and lid erythema or scales. Slit lamp findings higher than grade 2 bias the patient toward an adverse event and it may be difficult to detect true change related to contact lens use.
8. The patient is pregnant.
D: Inclusion Criteria:

* The refractive error limited to ±5.00 spherical and ±0.75 cylindrical diopters
* Subjects with up-to-date optical prescription

Exclusion Criteria:

* Signs and symptoms of severe eye dryness or inflammation
* Substantial tear flow impairment
* Any systemic or ocular disorder known to compromise the ocular surface or tear film quality.
* At least two out of the following signs of dry eye disease:

  * Ocular Surface Disease Index higher or equal to 23,
  * Conjunctival staining higher or equal to 2 or/and corneal staining higher or equal to 2 (graded with Efron grading scale)
  * Fluorescein tear film break-up time shorter than 7 seconds.

Answer: D