NCT03519282CompletedNot Applicable
Clinical Evaluation of Biofinity Multifocal Toric Contact Lenses
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- CooperVision, Inc.
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Visual Acuity
Study Overview
Brief Summary
This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).
Detailed Description
This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Has had a self-reported oculo-visual examination in the last two years.
- •Is aged 40-75 years, inclusive and has full legal capacity to volunteer.
- •Has read and understood the participant information sheet.
- •Is willing and able to follow instructions and maintain the appointment schedule.
- •Is able to participate in Parts A and B related to this work.
- •Has a contact lens spherical prescription between +10.00 to -10.00D (inclusive).
- •Has an Add component to their spectacle refraction (between +0.75 and +2.50DS).
- •Has astigmatism between -0.75 and -5.75DC (based on the vertexed ocular refraction in each eye.
- •Can be satisfactorily fitted with the study lenses.
- •Is correctable to a visual acuity of 20/40 (0.30 logMAR) or better (in each eye) with their habitual vision correction or 20/25 (0.10 logMAR) best-corrected.
- •They have successfully worn soft contact lenses in the last six months
- •Has clear corneas and no active ocular disease.
- •Has not worn lenses for at least 12 hours before the examination.
- •Has an up-to-date pair of spectacles.
Exclusion Criteria
- •Has never worn contact lenses before.
- •Has any systemic disease affecting ocular health.
- •Is using any systemic or topical medications that will affect ocular health.
- •Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would, in the opinion of the investigator, affect the wearing of contact lenses.
- •Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye that would, in the opinion of the investigator, be problematic for their participation in the study.
- •Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- •Is aphakic.
- •Has undergone corneal refractive surgery.
- •Has a history of anaphylaxis or severe allergic reaction.
- •Has diabetes or an infectious or immunosuppressive disease which could contraindicate contact lens wear or pose a risk to the investigator.
- •They are pregnant or breast-feeding.
- •Is participating in any other type of eye-related clinical or research study.
Arms & Interventions
Test Multifocal Toric Lens
Experimental
comfilcon A multifocal toric lens
Intervention: comfilcon A multifocal toric lens (Device)
Test Multifocal Toric Lens
Experimental
comfilcon A multifocal toric lens
Intervention: omafilcon A Multifocal Toric Lens (Device)
omafilcon A Multifocal Toric Lens
Active Comparator
Control multifocal toric lens
Intervention: comfilcon A multifocal toric lens (Device)
omafilcon A Multifocal Toric Lens
Active Comparator
Control multifocal toric lens
Intervention: omafilcon A Multifocal Toric Lens (Device)
Outcomes
Primary Outcomes
Visual Acuity
Time Frame: Up to 2 hours
Visual Acuity (measured in LogMAR)
Secondary Outcomes
- Assessment of Visual Performance: Intermediate Task for Vision Quality and Clarity(Up to 2 hours)
- Assessment of Visual Performance: Distance Navigation Tasks for Vision Quality and Clarity(Up to 2 hours)
- Assessment of Visual Performance: Near Task for Vision Quality and Clarity(Up to 2 hours)
Investigators
Study Sites (1)
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