Visual performance assessment of prototype contact lenses in children and young adults

• Conditions: Myopia; Eye - Normal eye development and function

• Registration Number: ACTRN12614000063617
• Lead Sponsor: Brien Holden Vision Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

*Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent or have a parent / guardian who is able to give informed consent on the participant’s behalf.
*Be between 7 and 18 years old (inclusive), 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.
*Correctable to at least 6/12 (20/40) or better in each eye with contact lenses.

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, 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 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 or strabismus surgery.
*Any binocular vision problems which may be exacerbated with the use of the study products or prevent adequate use of the device such as amblyopia, strabismus, excessive phoria and accommodative or convergence difficulties.
*Contraindications to contact lens wear.
*Known allergy or intolerance to ingredients in any of the clinical trial products

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Acuity using LogMAR chart[Day 0 (at time of dispense); Day 7 (assessment visit)];Contrast Sensitivity using Pelli-Robson chart or equivalent [Day 0 (at time of dispense); Day 7 (assessment visit)]

Secondary Outcome Measures

Name	Time	Method
Subjective ratings from participants comparing prototype contact lenses and commercial control using numerical scales and Likert scales [Day 0 (at time of dispense); Day 2/4/6 (take-home questionnaire); Day 7 (assessment visit)]