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

CooperVision, Inc.43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Ametropia

Interventions

methafilcon A toric contact lensesDEVICE

Bilateral daily wear of methafilcon A toric contact lenses

fanfilcon A toric contact lensesDEVICE

Bilateral daily wear of fanfilcon A toric contact lenses

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Optometry Clinic, National Autonomous University

Mexico City, Mexico

Outcomes

Primary Outcomes

Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses

Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

Time frame: Baseline

Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses

Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

Time frame: 4 weeks

Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

Time frame: Baseline

Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

Time frame: 2 weeks

Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

Time frame: 4 weeks

Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses

Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea

Time frame: Baseline

Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses

Data from ClinicalTrials.gov

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Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea

Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea

Time frame: Baseline

Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea

Time frame: 2 weeks

Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea

Time frame: 4 weeks

Post-blink Movement Assessment by the Investigator - Methafilcon A Toric Contact Lenses

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).

Time frame: Baseline

Post-blink Movement Assessment by the Investigator - Methafilcon A Toric Contact Lenses

Time frame: 4 weeks

Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

Time frame: Baseline

Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

Time frame: 2 weeks

Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

Time frame: 4 weeks

Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses

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.

Time frame: Baseline

Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses

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.

Time frame: 4 weeks

Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

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.

Time frame: Baseline

Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

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.

Time frame: 2 weeks

Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

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.

Time frame: 4 weeks

Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses

Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position

Time frame: Baseline

Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses

Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position

Time frame: 4 weeks

Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position

Time frame: Baseline

Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position

Time frame: 2 weeks

Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses

Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position

Time frame: 4 weeks

Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses