Clinical trial NCT01965288: Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism
Official title: A Single-Center Study Comparing the Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism Over 1 Month of Daily Wear.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2013-10-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the clinical performance of the Biofinity Toric (comfilcon A) contact lens, versus Air Optix for Astigmatism (lotrafilcon B) over 1 month of daily wear.

Detailed description: Single masked, open label, randomized, bilateral, crossover study design comparing comfilcon A against lotrafilcon B lenses over 1 month of daily wear for each study lens. Each subject will be randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.

Eligibility criteria: Inclusion Criteria:

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

* Is between 18 and 40 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Is an adapted soft toric contact lens wearer
* Has a contact lens spherical prescription between +6.00 to - 10.00 (inclusive)
* Have no less than 0.75diopter (D) of astigmatism and no more than 2.25D in both eyes.
* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter.
* Patient contact lens refraction should fit within the available parameters of the study lenses.
* Is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so).
* Is willing to comply with the visit schedule

Exclusion Criteria:

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

* Has a contact lens prescription outside the range of the available parameters of the study lenses.
* Has a spectacle cylinder less than -0.75D or more than -2.25 D of cylinder in either eye.
* Has a history of not achieving comfortable contact lens wear (5 days per week; \> 8 hours/day)
* Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
* Presence of clinically significant (grade 2-4) anterior segment abnormalities
* Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
* Slit lamp findings that would contraindicate contact lens wear such as:

  * Pathological dry eye or associated findings
  * Pterygium, pinguecula, or corneal scars within the visual axis
  * Neovascularization \> 0.75 mm in from of the limbus
  * Giant papillary conjunctivitis (GCP) worse than grade 1
  * Anterior uveitis or iritis (past or present)
  * Seborrheic eczema, Seborrheic conjunctivitis
  * History of corneal ulcers or fungal infections
  * Poor personal hygiene
* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
* Has aphakia, keratoconus or a highly irregular cornea.
* Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.

Primary outcomes:
measure: Daily and Comfortable Wearing Time
timeFrame: Baseline
measure: Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction
timeFrame: Baseline
measure: Vision Quality Insertion, During Day, End Day
timeFrame: Baseline
measure: Vision Stability Insertion, During Day, End Day
timeFrame: Baseline
measure: Overall Sensation of Moistness
timeFrame: Baseline
measure: Overall Sensation of Smoothness
timeFrame: Baseline
measure: Comfort Satisfaction
timeFrame: Baseline
measure: Dryness Satisfaction
timeFrame: Baseline
measure: Handling Satisfaction
timeFrame: Baseline
measure: Lens Fit Satisfaction
timeFrame: Baseline
measure: Vision Satisfaction
timeFrame: Baseline
measure: Overall Satisfaction
timeFrame: Baseline
measure: Comfort Upon Contact Lens Insertion
timeFrame: Dispense
measure: Vision Satisfaction Upon Contact Lens Insertion
timeFrame: Dispense
measure: Vision Quality With Contact Lens Prescription
timeFrame: Dispense
measure: Vision Stability Upon Contact Lens Insertion
timeFrame: Dispense
measure: Visual Acuity logMAR
timeFrame: Dispense
measure: Centration
timeFrame: Dispense
measure: Corneal Coverage
timeFrame: Dispense
measure: Post Blink Movement
timeFrame: Dispense
measure: Lens Orientation Primary Gaze
timeFrame: Dispense
measure: Lens Marking Visibility
timeFrame: Dispense
measure: Lens Stability on Blink
timeFrame: Dispense
measure: Lens Stability 5-10 Min
timeFrame: Dispense
measure: Lens Overall Stability
timeFrame: Dispense
measure: Rotational Recovery 30/45 Deg
timeFrame: Dispense
measure: Overall Fit Acceptance
timeFrame: Dispense
measure: Daily and Comfortable Wearing Time
timeFrame: 2 weeks
measure: Daily and Comfortable Wearing Time
timeFrame: 4 weeks
measure: Participants Use of Rewetting Drops
timeFrame: 2 Weeks
measure: Participants Use of Rewetting Drops
timeFrame: 4 Weeks
measure: Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction
timeFrame: 2 weeks
measure: Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction
timeFrame: 4 weeks
measure: Vision Quality Insertion, During Day, End Day, Night
timeFrame: 2 weeks
measure: Vision Quality Insertion, During Day, End Day, Night
timeFrame: 4 weeks
measure: Vision Stability on Insertion, During Day, End Day
timeFrame: 2 weeks
measure: Vision Stability on Insertion, During Day, End Day
timeFrame: 4 weeks
measure: Overall Sensation of Moistness
timeFrame: 2 weeks
measure: Overall Sensation of Moistness
timeFrame: 4 weeks
measure: Overall Sensation of Smoothness
timeFrame: 2 weeks
measure: Overall Sensation of Smoothness
timeFrame: 4 weeks
measure: Comfort Satisfaction
timeFrame: 2 weeks
measure: Comfort Satisfaction
timeFrame: 4 weeks
measure: Dryness Satisfaction
timeFrame: 2 weeks
measure: Dryness Satisfaction
timeFrame: 4 weeks
measure: Handling Satisfaction
timeFrame: 2 weeks
measure: Handling Satisfaction
timeFrame: 4 weeks
measure: Vision Satisfaction
timeFrame: 2 weeks
measure: Vision Satisfaction
timeFrame: 4 weeks
measure: Lens Fit Satisfaction
timeFrame: 2 weeks
measure: Lens Fit Satisfaction
timeFrame: 4 weeks
measure: Overall Satisfaction
timeFrame: 2 weeks
measure: Overall Satisfaction
timeFrame: 4 weeks
measure: Wavefront Aberrations Root Mean Square (RMS) (3mm)
timeFrame: 2 Weeks
measure: Wavefront Aberrations RMS (3mm)
timeFrame: 4 Weeks
measure: Wavefront Aberrations RMS (5mm)
timeFrame: 2 Weeks
measure: Wavefront Aberrations RMS (5mm)
timeFrame: 4 Weeks
measure: Visual Acuity logMAR
timeFrame: 2 Weeks
measure: Visual Acuity logMAR
timeFrame: 4 Weeks
measure: Lens Orientation Primary Gaze
timeFrame: 2 weeks
measure: Lens Orientation Primary Gaze
timeFrame: 4 weeks
measure: Rotational Recovery 30/45 Deg
timeFrame: 2 weeks
measure: Rotational Recovery 30/45 Deg
timeFrame: 4 weeks
measure: Lens Surface Deposits
timeFrame: 2 weeks
measure: Lens Surface Deposits
timeFrame: 4 weeks
measure: Centration
timeFrame: 2 weeks
measure: Centration
timeFrame: 4 weeks
measure: Corneal Coverage
timeFrame: 2 weeks
measure: Corneal Coverage
timeFrame: 4 weeks
measure: Post Blink Movement
timeFrame: 2 weeks
measure: Post Blink Movement
timeFrame: 4 weeks
measure: Lens Marking Visibility
timeFrame: 2 weeks
measure: Lens Marking Visibility
timeFrame: 4 weeks
measure: Lens Stability on Blink
timeFrame: 2 weeks
measure: Lens Stability on Blink
timeFrame: 4 weeks
measure: Lens Stability 5-10 Min
timeFrame: 2 weeks
measure: Lens Stability 5-10 Min
timeFrame: 4 weeks
measure: Overall Stability
timeFrame: 2 weeks
measure: Overall Stability
timeFrame: 4 weeks
measure: Overall Fit Acceptance
timeFrame: 2 weeks
measure: Overall Fit Acceptance
timeFrame: 4 weeks
Secondary outcomes:
measure: Limbal Hyperaemia
timeFrame: Baseline
measure: Limbal Hyperaemia
timeFrame: 2 weeks
measure: Limbal Hyperaemia
timeFrame: 4 weeks
measure: Bulbar Hyperaemia
timeFrame: Baseline
measure: Bulbar Hyperaemia
timeFrame: 2 weeks
measure: Bulbar Hyperaemia
timeFrame: 4 weeks
measure: Lower Palpebral Hyperaemia
timeFrame: Baseline
measure: Lower Palpebral Hyperaemia
timeFrame: 2 weeks
measure: Lower Palpebral Hyperaemia
timeFrame: 4 weeks
measure: Corneal Stromal Haze
timeFrame: Baseline
measure: Corneal Stromal Haze
timeFrame: 2 weeks
measure: Corneal Stromal Haze
timeFrame: 4 weeks
measure: Corneal Neovascularization
timeFrame: Baseline
measure: Corneal Neovascularization
timeFrame: 2 weeks
measure: Corneal Neovascularization
timeFrame: 4 weeks
measure: Corneal Infiltrates
timeFrame: Baseline
measure: Corneal Infiltrates
timeFrame: 2 weeks
measure: Corneal Infiltrates
timeFrame: 4 weeks
measure: Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B)
timeFrame: 2 weeks
measure: Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A)
timeFrame: 2 weeks
measure: Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B)
timeFrame: 4 weeks
measure: Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A)
timeFrame: 4 weeks
measure: Participants Likelihood of Switching From Habitual Lenses to the Study Lenses
timeFrame: 4 weeks
measure: Participants Likelihood of Continuing to Wear the Study Lenses.
timeFrame: 4 weeks
measure: Participant Recommendation of a Study Lens to Friends, Family or Colleagues
timeFrame: 8 weeks
measure: Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues.
timeFrame: 8 weeks
measure: Participant Preference for Their Habitual Lenses or Either of the Study Lenses
timeFrame: 8 weeks
measure: Participant Preference for Either of the Study Lenses
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Optometry Research Group (GIO) - Optics Department, University of Valencia
Study officials:
affiliation: Optometry Research Group (GIO) - Optics Department, University of Valencia
name: Robert Montés-Mico, OD MPhil PhD
role: PRINCIPAL_INVESTIGATOR
References: