Clinical trial NCT02719353: A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses
Official title: A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2016-03-25
Enrollment: 14
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses.

Detailed description: This study is a 13-subject, randomized, prospective, single site, daily wear, single-masked (to the subject), bilateral, 4-day cross-over, dispensing study comparing the comfilcon A extended range multifocal test lens against the comfilcon A multifocal control lens.

Eligibility criteria: Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

* Has had a self-reported oculo-visual examination in the last two years
* Is 50 years of age or greater and has full legal capacity to volunteer
* Is able to read and understand the informed consent
* Is willing and able to follow instructions and maintain the appointment schedule
* Has a spherical distance contact lens prescription between -1.00 and -5.00D (Diopters) (inclusive)
* Near Add Power requirement of +2.25D or greater
* Has spectacle cylinder 0.75 D in both eyes
* Has normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
* Has monocular best-corrected distance visual acuity of 20/30 or better in each eye
* Has clear corneas and no active ocular disease
* Has not worn gas permeable contact lenses for 1 month prior to the study

Exclusion Criteria:

A person will be excluded from the study if he/she:

* 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 abnormality that would affect the wearing of contact lenses
* Is aphakic (i.e. missing their natural lens inside their eye)
* Has uncorrected anisometropia (i.e. difference in the prescription between the eyes) of ≥2.00 D
* Has undergone corneal refractive surgery
* Is participating in any other type of eye related clinical or research study.

Primary outcomes:
measure: Visual Acuity
timeFrame: 4 days
measure: Visual Performance
timeFrame: 4 days
Secondary outcomes:
measure: Subjective Ratings for Comfort
timeFrame: Baseline
measure: Subjective Ratings for Comfort
timeFrame: 4 days
measure: Subjective Ratings for Dryness
timeFrame: Baseline
measure: Subjective Ratings for Dryness
timeFrame: 4 days
measure: Lens Handling
timeFrame: 4 Days
measure: Average Daily Wearing Time
timeFrame: 4 days
measure: Lens Fit
timeFrame: 4 days
measure: Bulbar Hyperemia
timeFrame: 4 days
measure: Limbal Hyperemia
timeFrame: 4 days
measure: Subjective Satisfaction
timeFrame: 4 days
measure: Subjective Preference for Near Vision
timeFrame: 4 days
measure: Subjective Preference for Distance Vision
timeFrame: 4 days
measure: Subjective Preference for Intermediate Vision
timeFrame: 4 days
measure: Subjective Preference for Overall Vision
timeFrame: 4 days
measure: Subjective Preference for Comfort
timeFrame: 4 days
measure: Subjective Overall Lens Preference
timeFrame: 4 days
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: CORL, Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Pete S Kollbaum, O.D.
role: PRINCIPAL_INVESTIGATOR
References: