Refitting Somofilcon A Toric Contact Lens Wearers Into Fanfilcon A Toric Lenses for 4-weeks of Wear

NCT04050605 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-102
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective study is to evaluate the clinical performance of habitual wearers of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily wear.

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (20)

• Lens Centration - Somofilcon A Toric (Habitual) Lens

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

  Baseline

• Lens Centration - Somofilcon A Toric (Habitual) Lens

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

  4 weeks

• Lens Centration - Fanfilcon A Toric Lens

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

  Baseline

• Lens Centration - Fanfilcon A Toric Lens

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

  2-weeks

• Lens Centration - Fanfilcon A Toric Lens

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

  4-weeks

• Corneal Coverage - Somofilcon A Toric (Habitual ) Lens

  Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)

  Baseline

• Corneal Coverage - Somofilcon A Toric (Habitual ) Lens

  Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)

  4-weeks

• Corneal Coverage - Fanfilcon A Toric Lens

  Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)

  Baseline

• Corneal Coverage - Fanfilcon A Toric Lens

  Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)

  2-weeks

• Corneal Coverage - Fanfilcon A Toric Lens

  Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)

  4-weeks

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

  Post-Blink movement (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 - Somofilcon A Toric (Habitual) Lens

  Post-Blink movement (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 - Fanfilcon A Toric Lens

  Post-Blink movement (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 - Fanfilcon A Toric Lens

  Post-Blink movement (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 - Fanfilcon A Toric Lens

  Post-Blink movement (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

• Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens

  Overall fit acceptance - using a 0 - 4 scale (where 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 - Somofilcon A Toric (Habitual) Lens

  Overall fit acceptance - using a 0 - 4 scale (where 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 - Fanfilcon A Toric Lens

  Overall fit acceptance - using a 0 - 4 scale (where 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 - Fanfilcon A Toric Lens

  Overall fit acceptance - using a 0 - 4 scale (where 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 - Fanfilcon A Toric Lens

  Overall fit acceptance - using a 0 - 4 scale (where 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 Toric (Habitual) Lens

  4 weeks

• Average Daily Wearing Time - Fanfilcon A Toric Lens

  2 weeks

• Average Daily Wearing Time - Fanfilcon A Toric Lens

  4 weeks

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

  4 weeks

• Average Comfortable Wearing Time - Fanfilcon A Toric Lens

  2 weeks

Study Arms (1)

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

EXPERIMENTAL

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

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

Interventions

somofilcon A toric contact lens DEVICE

Contact Lens

Also known as: Habitual lens

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

fanfilcon A toric contact lens DEVICE

Contact Lens

Also known as: Test Lens

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

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 -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

You may not qualify if:

• 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 -2.50 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.
• 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

Astigmatism

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 preservative free 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

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

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 8, 2019
• Study Start: June 4, 2019
• Primary Completion: August 16, 2019
• Study Completion: October 18, 2019
• Last Updated: September 9, 2020
• Results First Posted: August 28, 2020

Record last verified: 2020-09

Locations

ME (1)