A prospective, single-masked, cross-over, randomised clinical trial assessing ocular comfort and ocular changes with and without lens replacement during the day with AIR OPTIX (trademark) AQUA contact lenses worn by experienced wearers over three days
- Conditions
- Contact lens wearEye - Normal eye development and functionOcular Comfort
- Registration Number
- ACTRN12609000430235
- Lead Sponsor
- CIBA VISIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
Be at least 18 years old;
Willing to comply with the wearing and clinical trial visit schedule as directed by the investigator;
Have ocular health findings considered to be normal” and which would not prevent the participant from safely wearing contact lenses;
Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
Be an experienced contact lens wearer;
Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses;
Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosis. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants;
An active corneal infection or any active ocular disease that would affect wearing of contact lenses;
Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the study;
Use of or a need for any systemic medication or topical medications which may alter normal ocular findings/are known to affect a participant’s ocular health/physiology or contact lens performance either in an adverse manner or risk providing a false positive.
N.B. Systemic antihistamines are allowed on an ‘as needed basis’, provided they are not used prophylactically during the trial;
Eye surgery within 12 weeks immediately prior to enrolment for this trial;
Previous corneal refractive surgery;
Contraindications to contact lens wear;
Currently enrolled in another clinical trial;
Participation in a clinical trial within the previous 2 weeks for dispensing studies and 48 hours between in-house studies;
The Investigator may, at his/her discretion, exclude anyone else who they believe may not be able to fulfil the study requirements, or if it is believed to be in the participant’s best interests.
N.B. Whilst pregnant or lactating women are not excluded from the trial, they must be able to complete the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjective ocular comfort with contact lenses. This will be assessed by using questionnaires which are to be completed at regular time points during the day.[day 1, 2, 3]
- Secondary Outcome Measures
Name Time Method Ocular response. This will assessed with a slit lamp biomicroscope, which is a specialised micrsocope used to view the eye.[day 1, 2, 3]