None listed
Conditions
Brief summary
To evaluate the ocular signs and symptoms following 2 hours of contact lens wear following soaking with 3 commercially available contact lens care multipurpose disinfectant solutions. Two types of lens materials will be used - a hydrogel lens (Etafilcon A) and silicone hydrogel lens (Comfilcon A). Both the dispensing investigators and the contact lens wearers will be masked.
Interventions
In this double masked, contralateral design study, participants will be administered (by a final year optometry student) with hydrogel or silicone hydrogel lenses soaked in either one of the 3 different contact lens care solutions; Biotrue, RevitaLens OcuTec and Opti-free PureMoist. All the contact lens and lens care solutions are available in the Australian market for use. Following soaking for either 1, 10 or 30 days, the lenses will be worn by one eye of the human participants. The other ey
In this double masked, contralateral design study, participants will be administered (by a final year optometry student) with hydrogel or silicone hydrogel lenses soaked in either one of the 3 different contact lens care solutions; Biotrue, RevitaLens OcuTec and Opti-free PureMoist. All the contact lens and lens care solutions are available in the Australian market for use. Following soaking for either 1, 10 or 30 days, the lenses will be worn by one eye of the human participants. The other eye will wear a lens of the same material that was soaked in sterile buffered saline solution (control). Both the lenses will look same, neither the participant nor examiner (Stage 5 optometry student under guidance of qualified optometrist) will know which eye is allocated for the control/MPS-soaked lens. The lens allocation will be assigned by a clinical research coordinator. The lens will remain in the participant’s eye for 2 hours, after which visual acuity will be measured and ocular signs and symptoms evaluated using slit lamp biomicroscopy, Oculus Keratograph and Lipiview imaging instruments. Each participant is expected to be evaluated at 9 different visits, for 3 different MPS solutions at 3 different time points of lens-solution soaking with at least 48 hours washout period in between visits. Participants will receive same type of lens for every visit.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
18 years or older; male or female Adequate understanding of English and be able to give informed consent Person with an ocular refractive prescription Non-experienced contact lens wearer Have no ocular history of surgery or injury and no recent or current history of ocular infection. Prescription range of -1.00 to -8.00 spherical power with 0.25 steps
Exclusion criteria
Pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would prevent the safe wearing of contact lenses. Any systemic disease that adversely affects ocular health such as Grave’s disease, epilepsy etc. Pregnancy or lactating (participant verbal confirmation is sufficient) An active corneal infection or ocular disease that would prevent wearing contact lenses safely Any medications (both systemic and ocular) that may alter normal ocular findings (i.e. contribute to ocular dryness) as well as affect the participant’s subjective response to contact lens wear.
Outcome results
None listed