Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear

NCT03974802 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-101
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses.

Conditions

Myopia

Outcome Measures

Primary Outcomes (25)

• Lens Centration for Somofilcon A (Habitual) Lens

  Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

  Baseline

• Lens Centration for Somofilcon A (Habitual) Lens

  Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

  4- weeks

• Lens Centration for Fanfilcon A (Test) Lens

  Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

  Baseline

• Lens Centration for Fanfilcon A (Test) Lens

  Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

  2-weeks

• Lens Centration for Fanfilcon A (Test) Lens

  Lens Centration was measured using a 3-point scale(1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

  4- weeks

• Lens Corneal Coverage for Somofilcon A (Habitual) Lens

  Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)

  Baseline

• Lens Corneal Coverage for Somofilcon A (Habitual) Lens

  Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)

  4 -weeks

• Lens Corneal Coverage for Fanfilcon A (Test) Lens

  Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)

  Baseline

• Lens Corneal Coverage for Fanfilcon A (Test) Lens

  Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)

  2-weeks

• Lens Corneal Coverage for Fanfilcon A (Test) Lens

  Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)

  4-weeks

• Percentage of Lens Tightness for Somofilcon A (Habitual) Lens

  Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)

  Baseline

• Percentage of Lens Tightness for Somofilcon A (Habitual) Lens

  Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)

  4-Weeks

• Percentage of Lens Tightness for Fanfilcon A (Test) Lens

  Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)

  Baseline

• Percentage of Lens Tightness for Fanfilcon A (Test) Lens

  Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)

  2-Weeks

• Percentage of Lens Tightness for Fanfilcon A (Test) Lens

  Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)

  4-Weeks

• Post-Blink Movement for Somofilcon A (Habitual) Lens

  Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)

  Baseline

• Post-Blink Movement for Somofilcon A (Habitual) Lens

  Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)

  4-weeks

• Post-Blink Movement for Fanfilcon A (Test) Lens

  Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)

  Baseline

• Post-Blink Movement for Fanfilcon A (Test) Lens

  Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)

  2-weeks

• Post-Blink Movement for Fanfilcon A (Test) Lens

  Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)

  4-weeks

• Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens

  Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)

  Baseline

• Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens

  Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)

  4-weeks

• Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens

  Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)

  Baseline

• Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens

  Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)

  2-weeks

• Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens

  Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)

  4-weeks

Secondary Outcomes (6)

• Average Daily Wearing Time - Somofilcon A (Habitual) Lens

  4-weeks

• Average Daily Wearing Time - Fanfilcon A (Test) Lens

  2-weeks

• Average Daily Wearing Time - Fanfilcon A (Test) Lens

  4-weeks

• Average Comfortable Wearing Time - Somofilcon A (Habitual) Lens

  4 weeks

• Average Comfortable Wearing Time - Fanfilcon A (Test) Lens

  2 weeks

Study Arms (1)

somofilcon A (habitual) lens, then fanfilcon A (test) lens

EXPERIMENTAL

Participants are habitual wearers of somofilcon A lens and refitted with fanfilcon A lens.

Device: somofilcon A contact lens; Device: fanfilcon A contact lens

Interventions

somofilcon A contact lens DEVICE

Contact Lens

Also known as: clariti elite, Habitual lens

somofilcon A (habitual) lens, then fanfilcon A (test) lens

fanfilcon A contact lens DEVICE

Contact Lens

Also known as: Avaira Vitality, Test lens

somofilcon A (habitual) lens, then fanfilcon A (test) lens

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 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 CL prescription outside the range of the available parameters of the study lenses.
• Has a spectacle cylinder of ≥ 1.00D 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.
• 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, 54090, Mexico

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

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

javega@coopervision.com

9256213761

Study Officials

• Ruben Velázquez Guerrero, MSc., FIACLE

  School of Optometry, National Autonomous University (UNAM), Mexico City

  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: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: First pair of study lenses (habitual lenses) will be dispensed and worn for 4 weeks for daily wear, then second pair of lenses (test lenses) will be dispensed and worn for 4 weeks for daily wear.

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 5, 2019
• Study Start: May 14, 2019
• Primary Completion: July 24, 2019
• Study Completion: August 28, 2019
• Last Updated: August 18, 2020
• Results First Posted: August 18, 2020

Record last verified: 2020-08

Locations

ME (1)