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:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT01163760
Eligibility Criteria:
Inclusion Criteria:
* Be between 21 and 39 years of age.
* Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
* Be existing (i.e. successfully worn for 1-month prior to the study) soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
* Require a visual correction in both eyes (monovision allowed but no monofit).
* Have a contact lens spherical distance requirement between -1.00D and -6.00D in both eyes.
* Astigmatism of 1.00D or less in both eyes.
* Be able to wear the lens powers available for this study.
* Be correctable to a visual acuity of 20/30 or better in each eye.
* 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.
* No conjunctival abnormality or infection.
* No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularisation, infiltrates or abnormal opacities).
* No other active ocular disease.
Exclusion Criteria:
* Requires concurrent ocular medication.
* Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
* Clinically significant (Grade 3 or 4) corneal edema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
* Diabetic.
* Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
* Extended lens wear in last 3 months.
* PMMA or RGP lens wear in the previous 8 weeks.
* Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
* Abnormal lacrimal secretions.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Keratoconus or other corneal irregularity.
* Pregnancy, lactating or planning a pregnancy at the time of enrollment.
* Participation in any concurrent clinical trial or in last 60 days."
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
39 Years
Study:
NCT01163760
Study Brief:
Protocol Section:
NCT01163760