Clinical trial NCT03835221: Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month
Official title: Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ametropia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2019-02-08
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A toric lenses after a refit with fanfilcon A toric lenses for 1-month of daily wear.


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 - 8.00 (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:

* Has a Contact Lens (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 Contact Lens (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: Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses
timeFrame: Baseline
measure: Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses
timeFrame: 4 weeks
measure: Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
timeFrame: Baseline
measure: Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
timeFrame: 2 weeks
measure: Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
timeFrame: 4 weeks
measure: Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses
timeFrame: Baseline
measure: Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses
timeFrame: 4 weeks
measure: Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
timeFrame: Baseline
measure: Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
timeFrame: 2 weeks
measure: Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
timeFrame: 4 weeks
measure: Post-blink Movement Assessment by the Investigator - Methafilcon A Toric Contact Lenses
timeFrame: Baseline
measure: Post-blink Movement Assessment by the Investigator - Methafilcon A Toric Contact Lenses
timeFrame: 4 weeks
measure: Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
timeFrame: Baseline
measure: Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
timeFrame: 2 weeks
measure: Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
timeFrame: 4 weeks
measure: Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses
timeFrame: Baseline
measure: Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses
timeFrame: 4 weeks
measure: Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
timeFrame: Baseline
measure: Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
timeFrame: 2 weeks
measure: Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
timeFrame: 4 weeks
measure: Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses
timeFrame: Baseline
measure: Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses
timeFrame: 4 weeks
measure: Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
timeFrame: Baseline
measure: Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
timeFrame: 2 weeks
measure: Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
timeFrame: 4 weeks
measure: Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses
timeFrame: Baseline
measure: Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses
timeFrame: 4 weeks
measure: Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
timeFrame: Baseline
measure: Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
timeFrame: 2 weeks
measure: Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
timeFrame: 4 weeks
measure: Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses
timeFrame: Baseline
measure: Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses
timeFrame: 4 weeks
measure: Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses
timeFrame: Baseline
measure: Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses
timeFrame: 2 weeks
measure: Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses
timeFrame: 4 weeks
Secondary outcomes:
measure: Average Daily Wearing Time - Methafilcon A Toric Contact Lenses
timeFrame: 4 weeks
measure: Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses
timeFrame: 2 weeks
measure: Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses
timeFrame: 4 weeks
measure: Average Comfortable Wearing Time - Methafilcon A Toric Contact Lenses
timeFrame: 4 weeks
measure: Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses
timeFrame: 2 weeks
measure: Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Optometry Clinic, National Autonomous University
Study officials:
affiliation: School of Optometry, National Autonomous University
name: Ruben Velazquez, MSc FIACLE
role: PRINCIPAL_INVESTIGATOR
References: