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

Primary Purpose

Ametropia

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
methafilcon A toric contact lenses
fanfilcon A toric contact lenses
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ametropia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Optometry Clinic, National Autonomous University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

methafilcon A toric / fanfilcon A toric contact lenses

Arm Description

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.

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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).
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
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
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
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
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
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).
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).
Post-blink Movement Assessment by the Investigator - Fanfilcon 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).
Post-blink Movement Assessment by the Investigator - Fanfilcon 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).
Post-blink Movement Assessment by the Investigator - Fanfilcon 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).
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.
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.
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.
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.
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.
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
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
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
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
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
Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses
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 - Methafilcon A Toric Contact Lenses
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
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
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
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
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.
Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses
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.
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses
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.
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses
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.
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses
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

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

Full Information

First Posted
January 31, 2019
Last Updated
May 26, 2020
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03835221
Brief Title
Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month
Official Title
Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
March 27, 2019 (Actual)
Study Completion Date
July 6, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Study lenses will be transferred, by an assistant, out of their packaging to unmarked new contact lens cases filled with unpreserved sterile saline just prior to dispensing to maintain subject masking of the study lenses
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
methafilcon A toric / fanfilcon A toric contact lenses
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
methafilcon A toric contact lenses
Intervention Description
Bilateral daily wear of methafilcon A toric contact lenses
Intervention Type
Device
Intervention Name(s)
fanfilcon A toric contact lenses
Intervention Description
Bilateral daily wear of fanfilcon A toric contact lenses
Primary Outcome Measure Information:
Title
Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Description
Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame
Baseline
Title
Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Description
Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame
4 weeks
Title
Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description
Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame
Baseline
Title
Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description
Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame
2 weeks
Title
Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description
Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame
4 weeks
Title
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Description
Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Time Frame
Baseline
Title
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Description
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
Title
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description
Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Time Frame
Baseline
Title
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description
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
Title
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description
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
Title
Post-blink Movement Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Description
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
Title
Post-blink Movement Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Description
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
4 weeks
Title
Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description
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
Title
Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description
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
2 weeks
Title
Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description
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
4 weeks
Title
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses
Description
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
Title
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses
Description
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
Title
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description
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
Title
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description
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
Title
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description
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
Title
Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Description
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
Title
Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Description
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
Title
Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description
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
Title
Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description
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
Title
Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description
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
Title
Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Description
Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
Time Frame
Baseline
Title
Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses
Description
Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
Time Frame
4 weeks
Title
Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description
Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
Time Frame
Baseline
Title
Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description
Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
Time Frame
2 weeks
Title
Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses
Description
Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).
Time Frame
4 weeks
Title
Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses
Description
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.
Time Frame
Baseline
Title
Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses
Description
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.
Time Frame
4 weeks
Title
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses
Description
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.
Time Frame
Baseline
Title
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses
Description
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.
Time Frame
2 weeks
Title
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Average Daily Wearing Time - Methafilcon A Toric Contact Lenses
Description
Average daily wearing time response by the subject
Time Frame
4 weeks
Title
Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses
Description
Average daily wearing time response by the subject
Time Frame
2 weeks
Title
Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses
Description
Average daily wearing time response by the subject
Time Frame
4 weeks
Title
Average Comfortable Wearing Time - Methafilcon A Toric Contact Lenses
Description
Average comfortable wearing time - response by the subject
Time Frame
4 weeks
Title
Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses
Description
Average comfortable wearing time - response by the subject
Time Frame
2 weeks
Title
Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses
Description
Average comfortable wearing time - response by the subject
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruben Velazquez, MSc FIACLE
Organizational Affiliation
School of Optometry, National Autonomous University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optometry Clinic, National Autonomous University
City
Mexico City
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

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

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