The effect of of different contact lens designs on contact lens dissatisfaction from binocular vision disorders in non-presbyopic adult contact lens wearers.

Not Applicable

Completed

• Conditions: Myopia; Binocular vision disorder; Contact lens discomfort; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12618001901291
• Lead Sponsor: Brien Holden Vision Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-22
• Study Completion: 2019-08-31
• Last Update Posted: 30 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Be between 18-40 years old, 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.
Be an experienced soft contact lens wearer.
Be myopic with less than or equal to 1.00 D of cylindrical power in either eye.
Be correctable to better than 0.20 logMAR in each eye with single vision contact lenses.
Be able to insert and remove contact lenses.
Score greater than or equal to 15 on the OSDI questionnaire at baseline, while wearing habitual contact lenses.
BVD Group: Have a binocular vision disorder profile at baseline, while wearing habitual contact lenses
CLD Group: Score greater than or equal to 12 on the CLDEQ-8 but not have a binocular vision disorder profile at baseline, while wearing habitual 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.
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.
Previous surgery on the extra ocular muscles.
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*.
The Investigator may, at his 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.
*Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.

Study & Design

• Study Type: Interventional
• Study Design: Not specified