Clinical Performance of Habitual Hydrogel vs. Silicone Hydrogel Toric Contact Lenses

Not Applicable

Completed

Conditions: Astigmatism

Interventions: Device: enfilcon A

Registration Number: NCT02142361

Lead Sponsor: Coopervision, Inc.

Brief Summary: Evaluate the clinical performance of existing wearers of hydrogel toric lenses when refitted with Avaira toric silicone hydrogel contact lenses over 1 week of wear.

Detailed Description: This is a 60-subject, single masked, bilateral, parallel study design comparing the fitting characteristics of enfilcon A toric lenses against the subjects habitual hydrogel toric lenses (omafilcon A, ocufilcon D or methafilcon B wearers). Subject's habitual toric lenses will be evaluated at the first visit and then re-fitted with a pair of Avaira toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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 toric 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 1.75 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 prescription outside the range of the available parameters of the study lenses.
Has a spectacle cylinder less than -0.75D or more than -1.75D of cylinder in either eye.
Has a history of not achieving comfortable contact lens 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: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ocufilcon D/Enfilcon A	enfilcon A	Subject's habitual hydrogel toric lenses Ocufilcon D will be evaluated at the first visit and then re-fitted with a pair of Enfilcon A lenses.
Omafilcon A/Enfilcon A	enfilcon A	Subject's habitual hydrogel toric lenses Omafilcon A will be evaluated at the first visit and then re-fitted with a pair of Enfilcon A lenses.
Methafilcon B/ Enfilcon A	enfilcon A	Subject's habitual hydrogel toric lenses Methafilcon B will be evaluated at the first visit and then re-fitted with a pair of Enfilcon A lenses.

Primary Outcome Measures

Name	Time	Method
Participant's Subjective Rating for Overall Lens Comfort	Baseline and 1 week	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)
Participant's Subjective Rating for Vision Quality at Insertion	Baseline and 1 week	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week .Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)
Participant's Subjective Rating for Overall Dryness	Baseline and 1 week	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)
Participant's Subjective Rating for Overall Vision Satisfaction	Baseline and 1 week	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=completely dissatisfied, 10= very satisfied)
Participant's Subjective Rating for Lens Comfort Prior to Removal	Baseline and 1 week	Surveyed prior to removal of each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)
Participant's Subjective Rating for Dryness During the Day	Baseline and 1 week	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)
Participant's Subjective Rating for Dryness Prior to Removal	Baseline and 1 week	Surveyed prior to removal of each lens pair. Habitual pair at baseline . Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)
Participant's Subjective Rating for Lens Handling - Insertion	Baseline and 1 week	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= very easy)
Participant's Subjective Rating for Night Vision Quality	Baseline and 1 week	Surveyed for each lens pair. Habitual pair at baseline. Study pair dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)
Participant's Subjective Rating for Overall Satisfaction - Lens Fit	Baseline and 1 week	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye	Baseline and 1 week	Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees.
Participant's Subjective Rating for Lens Initial Comfort	Baseline and 1 week	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)
Participant's Subjective Rating for Vision Quality End of the Day	Baseline and 1 week	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week end of the day. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)
Participant's Subjective Rating for Overall Satisfaction - Dryness	Baseline and 1 week	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Participant's Subjective Rating for Overall Satisfaction - Overall	Baseline and 1 week	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Clinician's Objective Assessment Monocular High Contrast Distance Visual	Baseline and 1 week	Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value.
Clinician's Assessment Corneal Coverage-Right Eye	Baseline and 1 week	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no, incomplete corneal coverage)
Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye	Baseline and 1 week	Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees.
Participant's Subjective Rating for Overall Lens Fit Stability	Baseline and 1 week	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very unstable / excessive movement, 10= very stable / good movement)
Participant's Subjective Rating for Vision Quality During the Day	Baseline and 1 week	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)
Participant's Subjective Rating for Vision Stability at End of Day	Baseline and 1 week	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)
Participant's Subjective Rating for Overall Satisfaction - Handling	Baseline and 1 week	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Clinician's Assessment Overall Fit Acceptance- Right Eye	Baseline and 1 week	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)
Clinician's Assessment Lens Centration- Left Eye	Baseline and 1 week	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Lens centration recorded by degree and direction in the primary positions. (0-2, 0=centered/optimal, 1=decentered slightlty, 2=substantially decentered (\>0.5mm)
Clinician's Assessment Post-Blink Movement- Right Eye	Baseline and 1 week	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement
Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Left Eye	Baseline and 1 week	Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.
Participant's Subjective Rating for Vision Stability at Insertion	Baseline and 1 week	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)
Participant's Subjective Rating for Lens Pair Preference	1 week	Participants subjective preference in relation to comfort, dryness, handling, vision, lens fit and overall of the patient after wearing the study and their habitual lenses.
Clinician's Assessment Overall Lens Stability-Left Eye	Baseline and 1 week	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)
Clinician's Assessment Overall Fit Acceptance- Left Eye	Baseline and 1 week	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)
Clinicians Assessment Corneal Coverage-Left Eye	Baseline and 1 week	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no incomplete corneal coverage)
Clinician's Assessment Post-Blink Movement-Left Eye	Baseline and 1 week	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement
Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Right Eye	Baseline and 1 week	Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.
Participant's Subjective Rating for Overall Satisfaction - Comfort	Baseline and 1 week	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Participant's Subjective Rating for Vision Stability During the Day	Baseline and 1 week	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)
Participant's Subjective Rating for Overall Satisfaction - Vision	Baseline and 1 week	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)
Clinician's Objective Assessment Binocular High Contrast Distance Visual Acuity	Baseline and 1 week	Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value
Clinician's Assessment Overall Lens Stability-Right Eye	Baseline and 1 week	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)
Clinician's Assessment Lens Centration-Right Eye	Baseline and 1 week	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Lens centration recorded by degree and direction in the primary position. (0-2, 0=centered/optimal, 1=decentered slightly, 2=substantially decentered (\>0.5mm))