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 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
NCT ID:
NCT01335750
Eligibility Criteria:
Inclusion Criteria:
* Informed Consent and HIPAA document read, signed, and dated.
* Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with hydrogel or silicone hydrogel contact lenses.
* Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to the study.
Exclusion Criteria:
* History of hypersensitivity
* Evidence or history of epithelial herpes simplex keratitis (dendritic keratitis; vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva and/or eyelids; bacterial infection of the eye; and/or fungal disease of the eye
* One functional eye or a monofit eye
* Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis
* Type 2 (macropunctate) or greater corneal staining in any region in either eye as observed by slit-lamp at Visit 1 of each study period
* Sum of the type of corneal staining greater than or equal to 4 across entire cornea in either eye as observed by slit-lamp at Visit 1 of each study period
* Conjunctival staining covering greater than or equal to 20% in 2 or more corneal regions in either eye as observed by slit-lamp at Visit 1 of each study period
* Conjunctival injection greater than Grade 2 (moderate-diffuse redness) in either eye as observed by slit-lamp at Visit 1 of each study period
* Abnormal lenticular opacity in the visual axis of the lens in either eye
* Use of concomitant topical Rx or over-the-counter (OTC) ocular medications
* History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear
* Pregnant or lactating females
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01335750
Study Brief:
Protocol Section:
NCT01335750