Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks

NCT03835078 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-98
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A aspheric lenses after a refit with fanfilcon A sphere lenses for 4 weeks of daily wear.

Conditions

Ametropia

Outcome Measures

Primary Outcomes (25)

• Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses

  Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

  Baseline

• Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses

  Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

  4 weeks

• Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses

  Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

  Baseline

• Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses

  Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

  2 weeks

• Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses

  Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

  4 weeks

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

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

  Baseline

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

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

  4 weeks

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

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

  Baseline

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

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

  2 weeks

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

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

  4 weeks

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

  Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

  Baseline

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

  Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

  4 weeks

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

  Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

  Baseline

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

  Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

  2 weeks

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

  Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

  4 weeks

• Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses

  Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).

  Baseline

• Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses

  Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).

  4 weeks

• Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses

  Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).

  Baseline

• Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses

  Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).

  2 weeks

• Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses

  Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).

  4 weeks

• Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses

  Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect

  Baseline

• Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses

  Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect

  4 weeks

• Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses

  Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect

  Baseline

• Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses

  Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect

  2 weeks

• Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses

  Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect

  4 weeks

Secondary Outcomes (6)

• Average Daily Wearing Time - Methafilcon A Contact Lenses

  4 weeks

• Average Daily Wearing Time - Fanfilcon A Contact Lenses

  2 weeks

• Average Daily Wearing Time - Fanfilcon A Contact Lenses

  4 weeks

• Average Comfortable Wearing Time - Methafilcon A Contact Lenses

  4 weeks

• Average Comfortable Wearing Time - Fanfilcon A Contact Lenses

  2 weeks

Study Arms (1)

methalfilcon A contact lenses / fanfilcon A contact lenses

EXPERIMENTAL

All subjects will first wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.

Device: methafilcon A contact lenses; Device: fanfilcon A contact lenses

Interventions

methafilcon A contact lenses DEVICE

Bilateral daily wear of methafilcon A contact lenses

methalfilcon A contact lenses / fanfilcon A contact lenses

fanfilcon A contact lenses DEVICE

Bilateral daily wear of fanfilcon A contact lenses

methalfilcon A contact lenses / fanfilcon A contact lenses

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 contact lens wearer
• Has a contact lens spherical prescription between - 0.25 to - 8.00 (inclusive)
• Have no less than -0.75D (Diopter) of astigmatism 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 (CL) prescription outside the range of the available parameters of the study lenses
• Has a spectacle cylinder of ≥ 1.00D (Diopter) 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

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Optometry Clinic, National Autonomous University

Mexico City, Mexico

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Jose A. Vega, O.D, MSc., FAAO
• Organization: CooperVision. Inc

javega@coopervision.com

9256213761

Study Officials

• Ruben Velazquez, MSc FIACLE

  School of Optometry, National Autonomous University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 8, 2019
• Study Start: January 1, 2019
• Primary Completion: March 27, 2019
• Study Completion: July 6, 2019
• Last Updated: June 11, 2020
• Results First Posted: June 11, 2020

Record last verified: 2020-05

Locations

ME (1)