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 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
NCT ID:
NCT00813761
Eligibility Criteria:
Inclusion Criteria:
* Be at least 18 years old.
* Signed Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
* Require a visual correction in both eyes (monovision allowed but not monofit).
* Have a contact lens spherical distance requirement between +6.00D and -9.00D in both eyes.
* Astigmatism of 1.00D or less in the better eye and 1.50D or less in the other eye.
* Be correctable to a visual acuity of 20/30 (6/9) or better in each eye.
* Have normal eyes with no evidence of abnormality or 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 corneal edema, corneal vascularisation, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
* Worn lenses on an extended wear basis in the last 3 months.
* Diabetic.
* Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
* Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks.
* Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
* Abnormal lacrimal secretions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00813761
Study Brief:
Protocol Section:
NCT00813761