Clinical trial NCT02185105: Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses
Official title: Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2014-07-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study hypothesis is there is no difference in the clinical performance between the test and control lenses, in particular in lens stability, toric mislocation, comfort ratings and anterior segment ocular health findings.

Detailed description: Evaluate the clinical performance of Biofinity toric MTO lenses against current commercial Biofinity toric lenses over 6 hours of lens wear.

Eligibility criteria: Inclusion Criteria:

* Has had a self-reported 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 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
* Currently wears soft contact lenses.
* Has clear corneas and no active ocular disease.
* Has not worn lenses for at least 12 hours before the examination

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 affect the wearing of contact lenses.
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
* Is aphakic.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.

Primary outcomes:
measure: Lens Surface Assessment of Study Lenses - Surface Wettability
timeFrame: 15min & 6hrs
measure: Lens Surface Assessment of Study Lenses - Deposits
timeFrame: 15min & 6hrs
measure: Lens Surface Assessment of Study Lenses - Surface Acceptance
timeFrame: 15min & 6hrs
measure: Subjective Rating For Comfort - Comfort Since Last Visit
timeFrame: 15min, 3hrs, 6hrs
measure: Subjective Rating For Comfort Preference
timeFrame: 1min, 15min, 3hrs, 6hrs
measure: Subjective Rating For Handling - Insertion
timeFrame: 1 min
measure: Subjective Rating For Handling - Removal
timeFrame: 1 min
measure: Investigator's Assessment of Stability
timeFrame: 15min & 6hrs
measure: General Lens Fit - Fit Acceptance
timeFrame: 15min & 6hrs
measure: Lens Fitting - Rotation/Mislocation
timeFrame: Baseline, 15min & 6hrs
measure: Anterior Ocular Health - Corneal Staining (Central)
timeFrame: baseline & 6hrs
measure: Anterior Ocular Health - Corneal Staining (Nasal)
timeFrame: baseline & 6hrs
measure: Anterior Ocular Health - Corneal Staining (Temporal)
timeFrame: baseline & 6hrs
measure: Anterior Ocular Health - CornealStaining (Superior)
timeFrame: baseline & 6hrs
measure: Anterior Ocular Health - Corneal Staining (Inferior)
timeFrame: baseline & 6hrs
measure: Anterior Ocular Health - Conjunctival Staining (Nasal)
timeFrame: baseline & 6hrs
measure: Anterior Ocular Health - Conjunctival Staining (Superior)
timeFrame: baseline & 6hrs
measure: Anterior Ocular Health - Conjunctival Staining (Temporal)
timeFrame: baseline & 6hrs
measure: Anterior Ocular Health - Conjunctival Staining (Inferior)
timeFrame: baseline & 6hrs
Secondary outcomes:
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: