None listed
Conditions
Brief summary
Proclear's Phosphorylcholine (PC Technology TM ) has given Proclear lenses FDA clearance for the claim: “may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms relating to dryness during lens wear.” Such claim was debatable in previous literature. The purpose of this study is to evaluate clinical performance of Proclear 1-day contact lenses in terms of fitting, physiological and subjective responses. Such that comparison with other daily wear lenses especially new silicone hydrogel lenses can be made.
Interventions
performance of commercially available contact lens, Proclear (registered trademark) 1 Day used in daily disposable modality will be evaluated and compared to other daily wear contact lenses. Evaluation of those daily wear contact lenses are from previous studies done in BHVI.
Sponsors
Brien Holden Vision Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Be able to read, 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; Have vision correctable to at least 6/12 (20/40) or better in each eye with contact lenses; May be experienced or inexperienced at wearing contact lenses.
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 (Pharmacy only) 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 of 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; Known or suspected allergy to ingredients in contact lenses; Currently enrolled in another clinical trial; Participation in a clinical trial within the previous 2 weeks or participation in a short-term clinical trial within the previous 48 hours; Be pregnant* or plan to become pregnant during the trial or is currently breastfeeding. 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. * Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.
Outcome results
None listed