Clinical trial NCT02847169: Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear
Official title: Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2016-07-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this prospective study is to evaluate the clinical performance of filcon IV1 toric and ocufilcon D toric contact lenses after 1 week of wear in each pair.

Detailed description: This is a 30-subject, prospective, randomized, double masked, bilateral, 1 week cross-over study comparing the fitting characteristics of filcon IV1 toric lenses against ocufilcon D hydrogel toric lenses.

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 - 9.00 (inclusive)
  * Have no less than -0.75D of astigmatism and no more than -2.00 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 -2.00 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. Confidential EX-MKTG-66 Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear 10
  * 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: Overall Fit Acceptance
timeFrame: Baseline and 1 week
measure: Lens Centration
timeFrame: Baseline and 1 week
measure: Post-blink Movement
timeFrame: Baseline and 1 week
measure: Overall Stability
timeFrame: Baseline and 1 week
measure: Corneal Coverage
timeFrame: Baseline and 1 week
measure: Lens Orientation in Primary Position of Gaze
timeFrame: Baseline and 1 week
measure: Rotational Recovery in Degrees After 60 Seconds
timeFrame: Baseline and 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico D.F.
country: Mexico
facility: Optometry Clinic, National Autonomous University
Study officials:
affiliation: School of Optometry, National Autonomous University (UNAM)
name: Velázquez Guerrero, MSc., FIACLE
role: PRINCIPAL_INVESTIGATOR
References: