None listed
Conditions
Brief summary
The aim of this trial is to establish the ocular comfort profile with and without lens wear over a 12 hour period. The trial also aims to assess how the profiles are influenced by lens insertion at different times of the day and worn for four hours. The hypothesis for this trial is ocular comfort will decrease during the day and ocular comfort with lens wear will be rated worse than with no lens wear
Interventions
This is a prospective, cross-over, randomised, open label clinical trial with participants wearing AIR OPTIX AQUA contact lenses bilaterally for four days and one day of no lens wear, making five stages in total as defined below, following initial lens dispense.
Participants will initially be fitted with contact lenses. This is followed by five stages, with each stage corresponding to a twelve hour period. The starting time for each stage will preferably be determined for each participant as be
This is a prospective, cross-over, randomised, open label clinical trial with participants wearing AIR OPTIX AQUA contact lenses bilaterally for four days and one day of no lens wear, making five stages in total as defined below, following initial lens dispense. Participants will initially be fitted with contact lenses. This is followed by five stages, with each stage corresponding to a twelve hour period. The starting time for each stage will preferably be determined for each participant as being the time they would normally insert their contact lenses. The order of stages will be randomised. Subjective responses will be evaluated using a Take Home Questionnaire (THQ) at approximately every two hours during each stage.
Sponsors
CIBA VISION
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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 able to insert and remove contact lenses; Experienced contact lens wearer;
Exclusion criteria
Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) 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 (including systemic antihistamines) 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. 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.
Outcome results
None listed