Clinical trial NCT02193178: Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges
Official title: Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2014-07-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses.

Detailed description: The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses. Further, that a minimum of 80% of those enrolled will complete 2 weeks of lens wear with no contraindication to continue.

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)
* Currently wears soft toric contact lenses in both eyes
* Subject contact lens prescription must fall under one of the contact lens power ranges for at least one eye:

  * -20.00D to -10.50D spherical powers and cylinder powers from - 0.75 to -2.25
  * +8.50D to +20.00D spherical powers and cylinder powers from - 0.75 to -2.25
  * -20.00D to -6.50D spherical powers and cylinder powers from -2.75 to -5.75
  * -6.00D to +6.00D spherical powers and cylinder powers from -2.75 to -5.75
  * +6.50D to +20.00D spherical powers and cylinder powers from-2.75 to -5.75
* Has clear corneas and no active ocular disease
* Demonstrates an acceptable fit with the study lenses

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 abnormality that would affect the wearing of contact lenses;
* Has undergone corneal refractive surgery;
* Is participating in any other type of eye related clinical or research study.

Primary outcomes:
measure: Overall Comfort
timeFrame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
measure: Overall Vision
timeFrame: 2 weeks prior to baseline, Baseline, 2 weeks post
measure: Handling
timeFrame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
measure: Overall Satisfaction
timeFrame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
measure: Lens Fit - Rotation
timeFrame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
measure: Lens Fit - Overall Stability
timeFrame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
measure: Lens Fit Acceptance
timeFrame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
measure: Anterior Ocular Health - Palpebral Hyperemia and Roughness
timeFrame: Baseline and 2 weeks
measure: Anterior Ocular Health - Bulbar and Limbal Redness
timeFrame: Baseline and 2 weeks
measure: Anterior Ocular Health - Corneal Staining
timeFrame: Baseline and 2 weeks
measure: Anterior Ocular Health - Conjunctival Staining and Indentation
timeFrame: Baseline and 2 weeks
measure: Visual Acuity
timeFrame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
measure: Subjective Preference - Comfort
timeFrame: Baseline and 2 weeks
measure: Preference - Vision
timeFrame: Baseline and 2 weeks
measure: Preference - Handling
timeFrame: Baseline and 2 weeks
measure: Overall Preference
timeFrame: Baseline and 2 weeks
measure: Investigator Acceptability
timeFrame: Baseline and 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
state: Indiana
city: Houston
country: United States
facility: Texas Eye Research and Technology Center (TERTC) College of Optometry, University of Houston
state: Texas
Study officials:
affiliation: Texas Eye Research and Technology Center (TERTC), School of Optometry, University of Houston
name: Jan Bergmanson, OD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Optics Research Lab (CORL), Indiana University School of Optometry, Indiana University
name: Pete Kollbaum, OD PhD
role: PRINCIPAL_INVESTIGATOR
References: