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Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear

Primary Purpose

Astigmatism

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
filcon IV1 toric lens
ocufilcon D toric lens
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • A person is eligible for inclusion in the study if he/she:

    • 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 - 9.00 (inclusive)
    • Have no less than -0.75D of astigmatism and no more than -2.00 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:

  • A person will be excluded from the study if he/she:

    • Has a CL prescription outside the range of the available parameters of the study lenses.
    • Has a spectacle cylinder less than -0.75D or more than -2.00 D of cylinder in either eye.
    • Has a history of not achieving comfortable 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. Confidential EX-MKTG-66 Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear 10

    • 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.

Sites / Locations

  • Optometry Clinic, National Autonomous University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

filcon IV1 toric lens

ocufilcon D toric lens

Arm Description

Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.

Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.

Outcomes

Primary Outcome Measures

Overall Fit Acceptance
Investigator's preference for lens fit acceptance for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2= minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect
Lens Centration
Lens centration for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (Centered - optimal, decentered slightly, or substantially decentered).
Post-blink Movement
Post-blink movement for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=insufficient, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement.
Overall Stability
Overall lens stability for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=very poor stability, 4=excellent stability.
Corneal Coverage
Corneal coverage for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (yes=full corneal coverage or no=not full coverage)
Lens Orientation in Primary Position of Gaze
Lens rotation for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week with slit lamp by measuring within 10 degrees of the axis mark on the lens relative to the desired 6' o'clock position while the subject looked straight ahead.
Rotational Recovery in Degrees After 60 Seconds
Rotational recovery measured in degrees after 60 seconds for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and at 1 week by slit lamp.

Secondary Outcome Measures

Full Information

First Posted
July 25, 2016
Last Updated
March 28, 2017
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02847169
Brief Title
Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear
Official Title
Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this prospective study is to evaluate the clinical performance of filcon IV1 toric and ocufilcon D toric contact lenses after 1 week of wear in each pair.
Detailed Description
This is a 30-subject, prospective, randomized, double masked, bilateral, 1 week cross-over study comparing the fitting characteristics of filcon IV1 toric lenses against ocufilcon D hydrogel toric lenses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
filcon IV1 toric lens
Arm Type
Active Comparator
Arm Description
Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.
Arm Title
ocufilcon D toric lens
Arm Type
Active Comparator
Arm Description
Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.
Intervention Type
Device
Intervention Name(s)
filcon IV1 toric lens
Intervention Description
toric contact lens
Intervention Type
Device
Intervention Name(s)
ocufilcon D toric lens
Intervention Description
toric contact lens
Primary Outcome Measure Information:
Title
Overall Fit Acceptance
Description
Investigator's preference for lens fit acceptance for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2= minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect
Time Frame
Baseline and 1 week
Title
Lens Centration
Description
Lens centration for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (Centered - optimal, decentered slightly, or substantially decentered).
Time Frame
Baseline and 1 week
Title
Post-blink Movement
Description
Post-blink movement for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=insufficient, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement.
Time Frame
Baseline and 1 week
Title
Overall Stability
Description
Overall lens stability for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=very poor stability, 4=excellent stability.
Time Frame
Baseline and 1 week
Title
Corneal Coverage
Description
Corneal coverage for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (yes=full corneal coverage or no=not full coverage)
Time Frame
Baseline and 1 week
Title
Lens Orientation in Primary Position of Gaze
Description
Lens rotation for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week with slit lamp by measuring within 10 degrees of the axis mark on the lens relative to the desired 6' o'clock position while the subject looked straight ahead.
Time Frame
Baseline and 1 week
Title
Rotational Recovery in Degrees After 60 Seconds
Description
Rotational recovery measured in degrees after 60 seconds for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and at 1 week by slit lamp.
Time Frame
Baseline and 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A person is eligible for inclusion in the study if he/she: 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 - 9.00 (inclusive) Have no less than -0.75D of astigmatism and no more than -2.00 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: A person will be excluded from the study if he/she: Has a CL prescription outside the range of the available parameters of the study lenses. Has a spectacle cylinder less than -0.75D or more than -2.00 D of cylinder in either eye. Has a history of not achieving comfortable 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. Confidential EX-MKTG-66 Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear 10 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Velázquez Guerrero, MSc., FIACLE
Organizational Affiliation
School of Optometry, National Autonomous University (UNAM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optometry Clinic, National Autonomous University
City
Mexico D.F.
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear

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