None listed
Conditions
Brief summary
The primary purpose of this study is to determine whether ocular comfort can improved in symptomatic contact lens wearers by using a lens/solution combination which offers consistent performance
Interventions
This is a multiple-group, cross over, bilateral, double-masked clinical trial. Participants will use 2 combinations of lens/solution: ACUVUE ADVANCE/AQuify and PureVision/OPTI-FREE RepleniSH for seven consecutive days on a daily wear basis commencing the day after initial lens dispense. Visits will take place on day 1 and 8 of lens wear with each combination, and a minimum wash-out period of 48 hours will apply between each lens/solution combination.
Sponsors
Brien Holden Vision Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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; Has vision correctable to at least 6/12 (20/40) or better in each eye with contact lenses; Have participated in at least one of previous matrix trials (ANZCTR #: 12608000329369) and satisfy criteria for 'symptomatic' or 'non-symptomatic'. The definitions of 'symptomatic' or 'non-symptomatic' below are based solely on a participant's experience in previous matrix trials: Symptomatic contact lens wearers are defined as participants who have experienced a one point decrease or more in end-of-day ocular comfort compared to comfort-on-insertion at three scheduled visits. Non-symptomatic contact lens wearers will be classified as either 'primary' or 'secondary'. Secondary wearers will only be used if insufficient numbers are available from primary wearers: Primary wearers: participants who have experienced a less than one point decrease in end-of-day ocular comfort compared to comfort-on-insertion at three scheduled visits. Secondary wearers: participants who have not experienced a one point decrease or more in end-of-day ocular comfort compared to comfort-on-insertion at any scheduled visit, provided at least two visits were attended. Participants who have completed two or more matrix trials and satisfy the definition for both symptomatic and non-symptomatic wearers will be excluded from this trial.
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, Sjogrens 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 up to 12 weeks prior to and during the trial; 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; Be pregnant;
Outcome results
None listed