ACTRN12612000915853CompletedPhase 1
A prospective, bilateral, cross-over study to evaluate the safety and subjective acceptance of a novel contact lens multipurpose disinfecting solution and compare with a commercial solution during 1 month contact lens daily wear on experienced lens wearers
Brien Holden Vision Institute0 sites30 target enrollmentStarted: August 28, 2012Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Diagnosis
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
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.
- •Be experienced at wearing contact lenses.
- •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.
- •Correctable to at least 6/12 or better in each eye with contact lenses.
- •Be willing to not wear contact lenses for at least 2 days before each stage of the clinical trial.
Exclusion Criteria
- •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, Sjögrens 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 and at least 24 hours before the clinical trial product is 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 2 days between in-house studies.
- •Pregnancy* (Formal testing of pregnancy is not required. A participant’s verbal report is sufficient)
Investigators
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