Clinical trial NCT03519282: Clinical Evaluation of Investigational Multifocal Toric Contact Lenses
Official title: Clinical Evaluation of Biofinity Multifocal Toric Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2018-05-08
Enrollment: 13
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Acuity
timeFrame: Up to 2 hours
Secondary outcomes:
measure: Assessment of Visual Performance: Distance Navigation Tasks for Vision Quality and Clarity
timeFrame: Up to 2 hours
measure: Assessment of Visual Performance: Intermediate Task for Vision Quality and Clarity
timeFrame: Up to 2 hours
measure: Assessment of Visual Performance: Near Task for Vision Quality and Clarity
timeFrame: Up to 2 hours
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research
Study officials:
affiliation: Eurolens Research
name: Philip Morgan, BSc, PhD, MCOptom
role: PRINCIPAL_INVESTIGATOR
References: