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

NCT02142361 | Completed Results

• 1 other identifier: EX-MKTG-48
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (39)

• Participant's Subjective Rating for Lens Initial Comfort

  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)

  Baseline and 1 week

• Participant's Subjective Rating for Lens Comfort Prior to Removal

  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)

  Baseline and 1 week

• Participant's Subjective Rating for Overall Lens Comfort

  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)

  Baseline and 1 week

• Participant's Subjective Rating for Dryness During the Day

  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)

  Baseline and 1 week

• Participant's Subjective Rating for Dryness Prior to Removal

  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)

  Baseline and 1 week

• Participant's Subjective Rating for Overall Dryness

  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)

  Baseline and 1 week

• Participant's Subjective Rating for Lens Handling - Insertion

  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)

  Baseline and 1 week

• Participant's Subjective Rating for Overall Lens Fit Stability

  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)

  Baseline and 1 week

• Participant's Subjective Rating for Overall Vision Satisfaction

  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)

  Baseline and 1 week

• Participant's Subjective Rating for Vision Quality at Insertion

  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)

  Baseline and 1 week

• Participant's Subjective Rating for Vision Quality During the Day

  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)

  Baseline and 1 week

• Participant's Subjective Rating for Vision Quality End of the Day

  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)

  Baseline and 1 week

• Participant's Subjective Rating for Night Vision Quality

  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)

  Baseline and 1 week

• Participant's Subjective Rating for Vision Stability at Insertion

  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)

  Baseline and 1 week

• Participant's Subjective Rating for Vision Stability During the Day

  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)

  Baseline and 1 week

• Participant's Subjective Rating for Vision Stability at End of Day

  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)

  Baseline and 1 week

• Participant's Subjective Rating for Lens Pair Preference

  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.

  1 week

• Participant's Subjective Rating for Overall Satisfaction - Dryness

  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)

  Baseline and 1 week

• Participant's Subjective Rating for Overall Satisfaction - Handling

  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)

  Baseline and 1 week

• Participant's Subjective Rating for Overall Satisfaction - Vision

  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)

  Baseline and 1 week

• Participant's Subjective Rating for Overall Satisfaction - Lens Fit

  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)

  Baseline and 1 week

• Participant's Subjective Rating for Overall Satisfaction - Overall

  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)

  Baseline and 1 week

• Clinician's Objective Assessment Monocular High Contrast Distance Visual

  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.

  Baseline and 1 week

• Clinician's Objective Assessment Binocular High Contrast Distance Visual Acuity

  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

  Baseline and 1 week

• Clinician's Assessment Overall Lens Stability-Right Eye

  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)

  Baseline and 1 week

• Clinician's Assessment Overall Lens Stability-Left Eye

  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)

  Baseline and 1 week

• Clinician's Assessment Overall Fit Acceptance- Right Eye

  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)

  Baseline and 1 week

• Clinician's Assessment Overall Fit Acceptance- Left Eye

  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)

  Baseline and 1 week

• Clinician's Assessment Lens Centration-Right Eye

  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))

  Baseline and 1 week

• Clinician's Assessment Lens Centration- Left Eye

  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)

  Baseline and 1 week

• Clinician's Assessment Corneal Coverage-Right Eye

  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)

  Baseline and 1 week

• Clinicians Assessment Corneal Coverage-Left Eye

  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)

  Baseline and 1 week

• Clinician's Assessment Post-Blink Movement- Right Eye

  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

  Baseline and 1 week

• Clinician's Assessment Post-Blink Movement-Left Eye

  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

  Baseline and 1 week

• Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye

  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.

  Baseline and 1 week

• Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye

  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.

  Baseline and 1 week

• Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Right Eye

  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.

  Baseline and 1 week

• Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Left Eye

  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.

  Baseline and 1 week

• Participant's Subjective Rating for Overall Satisfaction - Comfort

  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)

  Baseline and 1 week

Study Arms (3)

Omafilcon A/Enfilcon A

ACTIVE COMPARATOR

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.

Device: enfilcon A

Ocufilcon D/Enfilcon A

ACTIVE COMPARATOR

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.

Device: enfilcon A

Methafilcon B/ Enfilcon A

ACTIVE COMPARATOR

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.

Device: enfilcon A

Interventions

enfilcon A DEVICE

Silicone hydrogel toric lenses.

Also known as: enfilcon A/Silicone Hydrogel Lens

Methafilcon B/ Enfilcon A; Ocufilcon D/Enfilcon A; Omafilcon A/Enfilcon A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Optometry Research Group (GIO) Optics Department, University of Valencia

Valencia, 46100, Spain

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Robert Montés-Mico O.D., MPhil, PhD Optometry
• Organization: Optometry Research Group (GIO)

robert.montes@uv.es

34-9635-44764

Study Officials

• Robert Montés-Mico, OD MPhil PhD

  Optometry Research Group (GIO) Optics Department, University of Valencia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: May 20, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 28, 2020
• Results First Posted: April 19, 2016

Record last verified: 2020-07

Locations

ES (1)