Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT01695369
Eligibility Criteria:
Inclusion Criteria:
Subjects must satisfy the following conditions prior to inclusion in the study:
* Has had an oculo-visual examination in the last two years
* Is at least 18 years of age and has full legal capacity to volunteer
* Has read and understood the information consent letter
* Is willing and able to follow instructions and maintain the appointment schedule
* Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction
* Currently wears soft contact lenses at least 3 days a week, 8 hours a day
* Has clear corneas and no active ocular disease
* Has not worn lenses for at least 12 hours before the examination
* Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
* No amblyopia
* No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes)
* No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection).
* No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea \[infiltrates\], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)
* No aphakia
* Has prescription to match the available power range.
Exclusion Criteria:
Any of the following will render a subject ineligible for inclusion:
* Greater than 0.75 of refractive astigmatism in either eye
* Has never worn contact lenses before
* Wears contact lenses on an extended wear basis
* Has any systemic disease affecting ocular health
* Is a known sufferer of ocular allergies
* Is taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
* Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities
* Is aphakic
* Has undergone corneal refractive surgery.
* Is wearing monovision
* Is participating in any other type of clinical or research study
* Female who is currently pregnant or is breast-feeding
* Has \> grade 1 ocular corneal staining in both type and extent by \> grade 2 in either type or extent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01695369
Study Brief:
Protocol Section:
NCT01695369