Clinical Performance of Existing Wearers of Enfilcon A Following a Refit With Fanfilcon A Lenses for 4 Weeks

NCT02670473 | Completed Results

• 1 other identifier: EX-MKTG-55 (CV-15-09)
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this dispensing study is to evaluate the clinical performance of habitual wearers of enfilcon A lenses following a refit with fanfilcon A lenses over 4 weeks of daily wear.

Conditions

Myopia

Outcome Measures

Primary Outcomes (4)

• Lens Fit - Centration

  Lens fit evaluation of centration for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: optimum, decentration acceptable, decentration unacceptable.

  Baseline, 1 week, 2 weeks, and 4 weeks

• Lens Fit - Post-blink Movement

  Lens fit evaluation of post-blink movement for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-5 Likert scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement.

  Baseline, 1 week, 2 weeks, and 4 weeks

• Lens Tightness on Push-up

  Lens fit evaluation of tightness on push-up test for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: 0%-100%, 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement.

  Baseline, 1 week, 2 weeks, and 4 weeks

• Overall Fit Acceptance

  Overall fit acceptance for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect.

  Baseline, 1 week, 2 weeks, and 4 weeks

Secondary Outcomes (9)

• Overall Comfort

  Baseline, 1 week, 2 weeks, and 4 weeks

• Dryness Overall

  Baseline, 1 week, 2 weeks, and 4 weeks

• Handling

  Baseline, 1 week, 2 weeks, and 4 weeks

• Overall Vision Satisfaction

  Baseline, 1 week, 2 weeks, and 4 weeks

• Overall Satisfaction

  Baseline, 1 week, 2 weeks, and 4 weeks

Study Arms (2)

enfilcon A (habitual)

NO INTERVENTION

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

fanfilcon A (test)

EXPERIMENTAL

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

Device: fanfilcon A (test)

Interventions

fanfilcon A (test) DEVICE

contact lens

fanfilcon A (test)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is between 18 and 40 years of age
• Has had a self-reported visual exam in the last two years
• Is an adapted enfilcon A contact lens wearer (at least 2 weeks in enfilcon A lens)
• Has a contact lens spherical prescription between -1.00 to - 6.00
• Has a spectacle cylinder up to 0.75D (Diopters) in each eye.
• 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:

• A person will be excluded from the study if he/she:
• Is not a habitual wearer of enfilcon A lenses
• Has a CL (Contact Lens) prescription outside the range of the available parameters of the study lenses.
• Has a spectacle cylinder ≥1.00D 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 3-4) 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

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Optometry Research Group (GIO) Optics Department, University of Valencia

Valencia, 46100, Spain

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Senior Manager Global Medical Scientific Affairs
• Organization: CooperVision Inc.

javega@coopervision.com

925 621-3761

Study Officials

• Robert Montés-Mico, O.D., PhD

  Optometry Research Group (GIO) University of Valencia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 1, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: February 5, 2018
• Results First Posted: March 21, 2017

Record last verified: 2017-07

Locations

ES (1)