Clinical trial NCT03418064: Performance of Toric Silicone Hydrogel Contact Lenses Following One Month of Daily Wear
Official title: Performance of Toric Silicone Hydrogel Contact Lenses Following One 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: 2018-02-01
Enrollment: 42
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 prospective study is to evaluate the clinical performance of fanfilcon A toric and lotrafilcon B toric contact lenses after 1 month of wear in each pair.

Detailed description: The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality toric (fanfilcon A) and AIR OPTIX for Astigmatism (lotrafilcon B) contact lenses after 1 month of wear in each pair.

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 contact lens wearer
* Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive)
* Have no less than -0.75D of astigmatism and no more than -2.25 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:

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

* Has a CL prescription outside the range of the available parameters of the study lenses.
* Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye.
* Has a history of not achieving comfortable CL 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: Lens Centration
timeFrame: Baseline
measure: Lens Centration
timeFrame: Dispense
measure: Lens Centration
timeFrame: 1 Month
measure: Corneal Coverage
timeFrame: Baseline
measure: Corneal Coverage
timeFrame: Dispense
measure: Corneal Coverage
timeFrame: 1 Month
measure: Post-blink Movement
timeFrame: Baseline
measure: Post-blink Movement
timeFrame: Dispense
measure: Post-blink Movement
timeFrame: 1 Month
measure: Overall Fit Acceptance
timeFrame: Dispense
measure: Overall Fit Acceptance
timeFrame: 1 Month
Secondary outcomes:
measure: Average Hours of Wear Per Day
timeFrame: Baseline
measure: Average Hours of Wear Per Day
timeFrame: 1 month
measure: Average Comfortable Wearing Time
timeFrame: Baseline
measure: Average Comfortable Wearing Time
timeFrame: 1 Month
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Optometry Clinic, National Autonomous University
Study officials:
References: