Prospective, participant-masked, bilateral wear, multiple arm, crossover dispensing clinical trial to assess visual performance of prototype contact lens designs compared to commercial contact lenses in participants with presbyopia and/or myopia

Not Applicable

Completed

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

• Registration Number: ACTRN12614000011684
• Lead Sponsor: Brien Holden Vision Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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 wearing contact lenses.
Correctable to at least 6/12 (20/40) or better in each eye with contact lenses.
Be willing to not wear contact lenses for a minimum of 2 days before each stage of the clinical trial (after informed consent).
Have at least +1.00D of Add prescription for presbyopes
Have at least -0.50D of myopic prescription for myopes

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 surgery.
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 will be assessed at distance and near with a computerised LogMAR chart and an MNRead Acuity chart respectively. [Day 1 (immediately after lens fit) and Day 5 (assessment visit)];Contrast sensitivity will be measured with a computerised LogMAR chart.[Day 1 (immediately after lens fit) and Day 5 (assessment visit)]

Secondary Outcome Measures

Name	Time	Method
Subjective ratings of clarity, ghosting, overall vision satisfaction and comfort with the lenses will be assessed for each pair of lenses with a questionnaire based on a 1-10 scale.[Day 1 (immediately after lens fit), Day 2-4 (two take home questionnaires) and Day 5 (assessment visit)];Participants' willingness to purchase the lenses, identified in a questionnaire.[Day 1 (immediately after lens fit), Day 2-4 (two take home questionnaires) and Day 5 (assessment visit)];Positive and negative aspects of the lenses, identified in a questionnaire.[Day 1 (immediately after lens fit), Day 2-4 (two take home questionnaires) and Day 5 (assessment visit)]