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 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT01392950
Eligibility Criteria:
Inclusion Criteria:
* Subjects will only be eligible for the study if:
1. They are 18 years of age and above.
2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They agree not to participate in other clinical research for the duration of this study.
5. They can attain at least 6/9 in each eye with the study contact lenses.
6. They have successfully worn contact lenses within six months of starting the study.
7. They can be fitted with spherical soft contact lenses within the power range available.
Exclusion Criteria:
* Subjects will not be eligible if:
1. They have an ocular disorder which would normally contra-indicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They have glaucoma (high pressure in the eye), have had cataract surgery or a history of recurring abrasions.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
7. They are pregnant or lactating.
8. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
9. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
63 Years
Study:
NCT01392950
Study Brief:
Protocol Section:
NCT01392950