None listed
Conditions
Brief summary
The results from this study will allow for further understanding of the ocular surface response and subjective comfort responses of the spectacle wearing population. By understanding spectacle wearer responses, it may contribute to the knowledge of the causes of discomfort in the contact lens wearing population. The hypothesis of the study is that there will be no difference in the ocular health and subjective comfort of spectacle wearers over the course of three months.
Interventions
Ocular health (by visual acuity measurements, autorefraction/subjective refraction, and slitlamp examination of the anterior eye) and comfort (by subjective comfort questionnaires) of spectacle wearers are assessed at the baseline, 2 hours, 2 weeks, 1 month and 3 months after the baseline during the course of the trial. The number of recruited participants may change to ensure the drop out number does not reduce the sample size to a level below what is required for the demonstration of statistic
Ocular health (by visual acuity measurements, autorefraction/subjective refraction, and slitlamp examination of the anterior eye) and comfort (by subjective comfort questionnaires) of spectacle wearers are assessed at the baseline, 2 hours, 2 weeks, 1 month and 3 months after the baseline during the course of the trial. The number of recruited participants may change to ensure the drop out number does not reduce the sample size to a level below what is required for the demonstration of statistical power and significance.
Sponsors
Brien Holden Vision Institute
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, male or female. 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 participating. Have a current pair of pre-prescribed spectacles Is correctable to at least 6/12 (20/40) or better in each eye with spectacles. Have not worn contact lenses within the previous twelve months (They may have worn lenses not totalling more than two weeks in the past twelve months)
Exclusion criteria
Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids. 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 erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants. Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical 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 or beneficial manner at enrolment and/or during the clinical trial. NB: 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.. Currently enrolled in another clinical trial. Participation in a clinical trial within the previous 2 weeks Pregnancy
Outcome results
None listed