None listed
Conditions
Brief summary
The purpose of this trial is to assess the effect of lens design on contact lens dissatisfaction in symptomatic, pre-presbyopic, CL wearers with a binocular vision disorder and / or contact lens discomfort.
Interventions
This trial will be a prospective, bilateral, randomized, double-masked, cross-over clinical trial.
Participants will wear three contact lens designs for two weeks each on a single-use, daily wear basis with a minimum 13 day wash-out between lens types. All contact lenses are made from etafilcon A material. One design contains a near addition (base curve 8.4, diameter 14.3, medium addition), one design has an extended depth of focus profile created by selective manipulation of multiple, spherical
This trial will be a prospective, bilateral, randomized, double-masked, cross-over clinical trial. Participants will wear three contact lens designs for two weeks each on a single-use, daily wear basis with a minimum 13 day wash-out between lens types. All contact lenses are made from etafilcon A material. One design contains a near addition (base curve 8.4, diameter 14.3, medium addition), one design has an extended depth of focus profile created by selective manipulation of multiple, spherical aberration terms (base curve 8.5, diameter 14.2, extended-depth-of-focus 0.75 D) and one lens has a flat peripheral optical profile (base curve 8.5, diameter 14.2). All lenses are available in distance power range -0.75 to -6.00 D. All lenses will be worn on daily-wear, daily disposable basis for about 2 weeks. The minimum wearing time will be 5 days per week and 6 hours per day when lenses are worn, with no maximum wearing time provided lenses are not slept in overnight. A minimum 13 day wash-out will be observed between lens types. There will 7 visits comprising Baseline and two visits for each of the three lens designs (Fitting and Assessment visits). All visits will be performed by a masked investigator and will be approximately 60 minutes in duration. Baseline visits will comprise completion of three validated questionnaires (ocular surface disease index [OSDI], convergence insufficiency syndrome survey [CISS], contact lens dry eye questionnaire-8 [CLDEQ-8]), visual acuity assessment and accommodative-convergence responses with habitual contact lenses. Auto-refraction, subjective refraction with visual acuity measurement and ocular assessment with a slit-lamp biomicroscope (a specialized microscope for viewing the eye) will be performed with no contact lens on eye. Fitting visits will comprise completion of three validated questionnaires (OSDI, CISS, CLDEQ-8), visual acuity assessment and accommodative-convergence responses with habitual contact lenses. Ocular assessment will be performed with a slit-lamp biomicroscope and visual acuity will be assessed with power-matched study lenses. Assessment visits will comprise completion of three validated questionnaires (OSDI, CISS, CLDEQ-8), visual acuity assessment and accommodative-convergence responses with study contact lenses. Ocular assessment will be performed with a slit-lamp biomicroscope. Participants will wear their habitual vision correction in between wearing study lens wear. All study contact lenses will be prescribed and all assessments will be carried out by an optometrist. Participants will be instructed to bring all unused contact lenses to each Assessment visit. Compliance will be assessed by comparing the number of lenses dispensed to the number of unused lenses, as well as verbal questioning of the participant.
Sponsors
Brien Holden Vision Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Outcome results
None listed