A trial to assess the visual performance of astigmatic contact lenses in young adults who are short-sighted
- Conditions
- MyopiaEye - Diseases / disorders of the eye
- Registration Number
- ACTRN12620001034921
- Lead Sponsor
- nthalmic Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 31
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Be at least 18 years of age but less than 40 years of age, male or female.
Willing to comply with the clinical trial 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 experience with wearing contact lenses.
Have myopia greater than 0.75 D and no more than 6.00 D.
Have best-corrected visual acuity at least 6/7.5.
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.
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 while wearing study lenses.
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.
Pregnancy at time of enrolment—verbal report sufficient.
The Investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant’s best interests.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference between test and control lenses for subjective visual performance. Participants will be asked to rate their vision with each contact lens on a non-validated 1-100 numeric rating scale.[Visit 2: (approximately 1-week post-enrolment - primary timepoint).<br>Visit 3: (approximately 2 weeks post-enrolment - primary timepoint).<br>Visit 4: (approximately 3 weeks post-enrolment - primary timepoint).<br>Visit 5: (approximately 4 weeks post-enrolment - primary timepoint).<br>Visit 6: (approximately 5 weeks post-enrolment - primary timepoint).<br>Visit 7: (approximately 6 weeks post-enrolment - primary timepoint).<br>Visit 8: (approximately 7 weeks post-enrolment - primary timepoint).<br>]
- Secondary Outcome Measures
Name Time Method Difference between test and control lenses for visual acuity. Visual acuity will be measured with a standard logMAR chart at 6 m.[Visit 2: (approximately 1-week post-enrolment).<br>Visit 3: (approximately 2 weeks post-enrolment).<br>Visit 4: (approximately 3 weeks post-enrolment).<br>Visit 5: (approximately 4 weeks post-enrolment).<br>Visit 6: (approximately 5 weeks post-enrolment).<br>Visit 7: (approximately 6 weeks post-enrolment).<br>Visit 8: (approximately 7 weeks post-enrolment).<br>]