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
CIBA VISION
20 participants
Aug 7, 2009
Interventional
Conditions
Summary
The aim of this trial is to assess changes in ocular comfort during the day, and whether ocular comfort is influenced by new lens replacement or re-insertion with the same lens after a brief soak in saline, during the day. The trial also aims to assess ocular changes and whether these correlate with changes in comfort. The hypothesis for this trial is ocular comfort will decrease with lens wear during the day whether lenses are replaced, the same lens is re-inserted or the same lens is worn uninterrupted for the day.
Eligibility
Inclusion Criteria6
- 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;
Exclusion Criteria13
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
This is a prospective, single-masked, cross-over, randomised clinical trial, with participants wearing AIR OPTIX AQUA contact lenses bilaterally over 3 days following initial lens dispense. Participants will initially be fitted with contact lenses . This is followed by three days of wear with the same lens type. Each day corresponds to one stage of the study. For two of the stages, participants will insert their own study lenses and these will be removed after approximately five hours of wear. Either the same lenses will be re-inserted after a brief soak in saline or a new pair of lenses will be inserted. For the other stage, participants will insert their own study lenses and wear the same lenses for the day without removal. The order in which this occurs will be randomised for all stages and masked when lenses are removed during the day. Subjective responses will also be evaluated at regular intervals during each stage. It is expected that most participants will have six scheduled visits, comprising the baseline visit followed by two stages with two visits per stage and one stage with one visit. * Baseline visit * Stages where lenses removed during the day o Visit 1 o Visit 2 * Stage where lenses not removed during the day: o Visit 1 * Take home questionnaires (THQ) at regular intervals during the day for all stages
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12609000430235