Evaluation of ocular response and subjective comfort ratings in forty participants with DAILIES TOTAL1 RegisteredTradeMark daily disposable contact lens wear for three months
Prospective, open-label, single group study where a minimum of 40 myopic participants will wear DAILIES TOTAL1 RegisteredTradeMark contact lenses bilaterally on a daily disposable basis for a total of three months to evaluate ocular response and subjective comfort ratings.
Brien Holden Vision Institute
40 participants
Mar 7, 2012
Interventional
Conditions
Summary
DAILIES TOTAL1 RegisteredTradeMark by CIBA VISION is one of the new silicone hydrogel daily disposable lenses recently released into the contact lens market. This study intends to provide more information on the clinical performance of DAILIES TOTAL1 RegisteredTradeMark in terms of ocular health, vision and subjective comfort. It will allow for comparisons to previous and future contact lens related studies in the hope that it can contribute to further understanding on what causes cotnact lens related discomfort and dryness. The hypothesis of this study is that the ocular responses and subjective comfort ratings will be dissimilar in participants wearing DAILIES TOTAL1 RegisteredTradeMark and other lens types.
Eligibility
Inclusion Criteria7
- 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 wearing contact lenses.
- Is myopic and correctable to at least 6/12 (20/40) or better in each eye with contact lenses.
- Be experienced or inexperienced at wearing contact lenses.
- Be able to insert and remove contact lenses, after tuition if required
Exclusion Criteria12
- Any pre-existing ocular irritation, injury or condition (including infection or disease) 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 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.
- N.B.: Systemic antihistamines are allowed on an “as needed basis”, provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is first used.
- Eye surgery within 12 weeks immediately prior to enrolment for this trial.
- Previous corneal refractive surgery.
- Contraindications to contact lens wear.
- Known allergy or intolerance to ingredients in any of the clinical trial products.
- 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.
- Pregnancy
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Interventions
DAILIES TOTAL1 RegisteredTradeMark contact lenses will be worn on a daily wear, single use basis for a minimum of 5 days per week, at least 6 hours per day (no overnight wear) for a duration of 3 months. DAILIES TOTAL1 RegisteredTradeMark contact lenses are made of Delefilcon A material.
Locations(1)
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ACTRN12612000120875