Clinical trial NCT02142361: Clinical Performance of Habitual Hydrogel vs. Silicone Hydrogel Toric Contact Lenses
Official title: Clinical Performance of Habitual Wearers of Hydrogel Toric Lenses When Refitted With Avaira Toric Silicone Hydrogel Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2014-05-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Evaluate the clinical performance of existing wearers of hydrogel toric lenses when refitted with Avaira toric silicone hydrogel contact lenses over 1 week of wear.

Detailed description: This is a 60-subject, single masked, bilateral, parallel study design comparing the fitting characteristics of enfilcon A toric lenses against the subjects habitual hydrogel toric lenses (omafilcon A, ocufilcon D or methafilcon B wearers). Subject's habitual toric lenses will be evaluated at the first visit and then re-fitted with a pair of Avaira toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.

Eligibility criteria: Inclusion Criteria:

* 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 - 8.00 (inclusive)
* Have no less than 0.75D of astigmatism and no more than 1.75 D 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:

* 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 -1.75D 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: Participant's Subjective Rating for Lens Initial Comfort
timeFrame: Baseline and 1 week
measure: Participant's Subjective Rating for Lens Comfort Prior to Removal
timeFrame: Baseline and 1 week
measure: Participant's Subjective Rating for Overall Lens Comfort
timeFrame: Baseline and 1 week
measure: Participant's Subjective Rating for Dryness During the Day
timeFrame: Baseline and 1 week
measure: Participant's Subjective Rating for Dryness Prior to Removal
timeFrame: Baseline and 1 week
measure: Participant's Subjective Rating for Overall Dryness
timeFrame: Baseline and 1 week
measure: Participant's Subjective Rating for Lens Handling - Insertion
timeFrame: Baseline and 1 week
measure: Participant's Subjective Rating for Overall Lens Fit Stability
timeFrame: Baseline and 1 week
measure: Participant's Subjective Rating for Overall Vision Satisfaction
timeFrame: Baseline and 1 week
measure: Participant's Subjective Rating for Vision Quality at Insertion
timeFrame: Baseline and 1 week
measure: Participant's Subjective Rating for Vision Quality During the Day
timeFrame: Baseline and 1 week
measure: Participant's Subjective Rating for Vision Quality End of the Day
timeFrame: Baseline and 1 week
measure: Participant's Subjective Rating for Night Vision Quality
timeFrame: Baseline and 1 week
measure: Participant's Subjective Rating for Vision Stability at Insertion
timeFrame: Baseline and 1 week
measure: Participant's Subjective Rating for Vision Stability During the Day
timeFrame: Baseline and 1 week
measure: Participant's Subjective Rating for Vision Stability at End of Day
timeFrame: Baseline and 1 week
measure: Participant's Subjective Rating for Lens Pair Preference
timeFrame: 1 week
measure: Participant's Subjective Rating for Overall Satisfaction - Dryness
timeFrame: Baseline and 1 week
measure: Participant's Subjective Rating for Overall Satisfaction - Handling
timeFrame: Baseline and 1 week
measure: Participant's Subjective Rating for Overall Satisfaction - Vision
timeFrame: Baseline and 1 week
measure: Participant's Subjective Rating for Overall Satisfaction - Lens Fit
timeFrame: Baseline and 1 week
measure: Participant's Subjective Rating for Overall Satisfaction - Overall
timeFrame: Baseline and 1 week
measure: Clinician's Objective Assessment Monocular High Contrast Distance Visual
timeFrame: Baseline and 1 week
measure: Clinician's Objective Assessment Binocular High Contrast Distance Visual Acuity
timeFrame: Baseline and 1 week
measure: Clinician's Assessment Overall Lens Stability-Right Eye
timeFrame: Baseline and 1 week
measure: Clinician's Assessment Overall Lens Stability-Left Eye
timeFrame: Baseline and 1 week
measure: Clinician's Assessment Overall Fit Acceptance- Right Eye
timeFrame: Baseline and 1 week
measure: Clinician's Assessment Overall Fit Acceptance- Left Eye
timeFrame: Baseline and 1 week
measure: Clinician's Assessment Lens Centration-Right Eye
timeFrame: Baseline and 1 week
measure: Clinician's Assessment Lens Centration- Left Eye
timeFrame: Baseline and 1 week
measure: Clinician's Assessment Corneal Coverage-Right Eye
timeFrame: Baseline and 1 week
measure: Clinicians Assessment Corneal Coverage-Left Eye
timeFrame: Baseline and 1 week
measure: Clinician's Assessment Post-Blink Movement- Right Eye
timeFrame: Baseline and 1 week
measure: Clinician's Assessment Post-Blink Movement-Left Eye
timeFrame: Baseline and 1 week
measure: Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye
timeFrame: Baseline and 1 week
measure: Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye
timeFrame: Baseline and 1 week
measure: Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Right Eye
timeFrame: Baseline and 1 week
measure: Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Left Eye
timeFrame: Baseline and 1 week
measure: Participant's Subjective Rating for Overall Satisfaction - Comfort
timeFrame: Baseline and 1 week
Secondary outcomes:
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: