Clinical trial NCT02060539: Multicenter Dispensing Study of Biofinity Lenses in Extended Range
Official title: Multicenter Dispensing Study of Biofinity Lenses in Extended Range
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Hyperopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2014-02-12
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To obtain subjective and objective feedback on the clinical performance of Biofinity lenses after at least two weeks daily wear in existing contact lens wearers compared with their habitual lenses.


Eligibility criteria: Inclusion Criteria:

* Has had an oculo-visual examination in the last two years
* Is at least 18 years of age and has full legal capacity to volunteer
* Has read and understood the information consent letter
* Is willing and able to follow instructions and maintain the appointment schedule
* Is correctable to a visual acuity of 20/50 or better (in at least one eye) with their habitual vision correction
* Currently wears soft contact lenses
* They should require contact lens powers between -12.00 and -20.00D or between +8.00 and +15.00D
* Has clear corneas and no active ocular disease
* Demonstrates an acceptable fit with the study lenses.

Exclusion Criteria:

* Has any systemic disease affecting ocular health
* Is taking medication, such as antihistamine eye drops, oral and ophthalmic betaadrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
* Have any active ocular disease and/or infection that would contraindicate contact lens wear.
* Active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
* Has worn gas permeable contact lenses within the last month.
* Is aphakic
* Has undergone corneal refractive surgery.
* Is participating in any other type of clinical research study
* Female who is currently pregnant or is breast-feeding.

Primary outcomes:
measure: Dryness (During Day and Dryness at Night)
timeFrame: Baseline
measure: Dryness (During Day)
timeFrame: Dispense
measure: Dryness (During Day and Dryness at Night)
timeFrame: 2 Weeks
measure: Comfort (Insertion, End of Day, Overall)
timeFrame: Baseline
measure: Comfort (Insertion)
timeFrame: Dispense
measure: Comfort (Insertion, End of Day, Overall)
timeFrame: 2 Weeks
measure: Ghosting (Multiple Images)
timeFrame: Baseline
measure: Ghosting (Multiple Images)
timeFrame: Dispense
measure: Ghosting (Multiple Images)
timeFrame: 2 Weeks
measure: Hazing (Blurred Edges)
timeFrame: Baseline
measure: Hazing (Blurred Edges)
timeFrame: 2 Weeks
measure: Vision Quality (During Day and at Night)
timeFrame: Baseline
measure: Vision Quality (During Day)
timeFrame: Dispense
measure: Vision Quality (During Day and at Night)
timeFrame: 2 Weeks
measure: Handling (Insertion, Removal, Overall)
timeFrame: Baseline
measure: Handling (Insertion, Removal, Overall)
timeFrame: 2 weeks
measure: Overall Satisfaction of Comfort, Vision, Handling
timeFrame: Dispense
measure: Overall Satisfaction of Comfort, Vision, Handling
timeFrame: Baseline
measure: Overall Satisfaction of Comfort, Vision, Handling
timeFrame: 2 Weeks
measure: Comfort Preference
timeFrame: Dispense
measure: Comfort Preference
timeFrame: 2 Weeks
measure: Vision Preference
timeFrame: Dispense
measure: Vision Preference
timeFrame: 2 Weeks
measure: Handling Preference
timeFrame: 2 Weeks
measure: Overall Preference
timeFrame: Dispense
measure: Overall Preference
timeFrame: 2 Weeks
Secondary outcomes:
measure: Lens Centration - Habitual Lenses
timeFrame: Baseline
measure: Lens Centration
timeFrame: Dispense
measure: Lens Centration
timeFrame: 2 Weeks
measure: Lens Movement - Habitual Lenses
timeFrame: Baseline
measure: Lens Movement
timeFrame: Dispense
measure: Lens Movement
timeFrame: 2 Weeks
measure: Overall Fit Acceptance
timeFrame: Baseline
measure: Overall Fit Acceptance
timeFrame: Dispense
measure: Overall Fit Acceptance
timeFrame: 2 Weeks
measure: Visual Acuity
timeFrame: Baseline
measure: Visual Acuity
timeFrame: Dispense
measure: Visual Acuity
timeFrame: 2 Weeks
measure: Anterior Ocular Physiological Response
timeFrame: Baseline
measure: Anterior Ocular Physiological Response
timeFrame: 2 Weeks
measure: Average Wearing Time
timeFrame: Baseline
measure: Average Wearing Time
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: UC Berkeley Clinica Research Center
state: California
city: Indianapolis
country: United States
facility: CORL, Indiana University School of Optometry
state: Indiana
city: Houston
country: United States
facility: TERTC, University of Houston
state: Texas
city: Waterloo
country: Canada
facility: CCLR, University of Waterloo
state: Ontario
Study officials:
affiliation: CCLR, University of Waterloo
name: Lyndon Jones
role: PRINCIPAL_INVESTIGATOR
affiliation: CRC, University of California Berkeley
name: Meng Lin
role: PRINCIPAL_INVESTIGATOR
affiliation: TERTC, University of Houston
name: Jan Bergmanson
role: PRINCIPAL_INVESTIGATOR
affiliation: CORL, Indiana University
name: Pete Kollbaum
role: PRINCIPAL_INVESTIGATOR
References: