Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month

Not Applicable

Completed

Conditions: Ametropia

Interventions: Device: methafilcon A toric contact lenses
Device: fanfilcon A toric contact lenses

Registration Number: NCT03835221

Lead Sponsor: Coopervision, Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 43

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
methafilcon A toric / fanfilcon A toric contact lenses	methafilcon A toric contact lenses	All subjects will first wear methafilcon A toric contact lenses for four (4) weeks of daily wear, then refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.
methafilcon A toric / fanfilcon A toric contact lenses	fanfilcon A toric contact lenses	All subjects will first wear methafilcon A toric contact lenses for four (4) weeks of daily wear, then refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	4 weeks	Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	4 weeks	Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Post-blink Movement Assessment by the Investigator - Methafilcon A Toric Contact Lenses	4 weeks	Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	4 weeks	Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses	4 weeks	Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.
Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses	4 weeks	Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	4 weeks	Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	4 weeks	Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position
Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses	4 weeks	Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses	4 weeks	Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses	4 weeks	Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.
Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses	4 weeks	Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	4 weeks	Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses	4 weeks	Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.

Secondary Outcome Measures

Name	Time	Method
Average Daily Wearing Time - Methafilcon A Toric Contact Lenses	4 weeks	Average daily wearing time response by the subject
Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses	4 weeks	Average comfortable wearing time - response by the subject
Average Comfortable Wearing Time - Methafilcon A Toric Contact Lenses	4 weeks	Average comfortable wearing time - response by the subject
Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses	4 weeks	Average daily wearing time response by the subject