Evaluation of CooperVision Avaira Toric (Enfilcon A) Soft Contact Lens When Compared to Acuvue Advance Toric Soft Contact Lens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01706770
First received: October 5, 2012
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

The primary objective of thes study is to confirm that the ocular response to the Test lenses are similar to those of the Control lenses when used in a 1 week planned replacement, daily wear modality over a 1-month period.


Condition Intervention Phase
Myopia
Device: Avaira Toric (enfilcon A) Soft Contact Lenses
Device: Acvuve Advance Toric (galyfilcon A) Soft Contact Lenses
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Evaluation of CooperVision Avaira Toric (Enfilcon A) Soft Contact Lens (Test) When Compared to Acuvue Advance Toric (Galyfilcon A) Soft Contact Lens (Control)

Resource links provided by NLM:


Further study details as provided by Coopervision, Inc.:

Primary Outcome Measures:
  • Slit lamp (biomicroscope) findings [ Time Frame: Baseline, 1 month ] [ Designated as safety issue: Yes ]
    The primary endpoint in this evaluation will be a comparison of the objective findings, including slit lamp (biomicroscope) findings and adverse events as associated with the Test contact lenses with those same findings reported as associated with the Control contact lenses

  • Adverse events [ Time Frame: Baseline, 1 month ] [ Designated as safety issue: Yes ]
    The primary endpoint in this evaluation will be a comparison of the objective findings, including slit lamp (biomicroscope) findings and adverse events as associated with the Test contact lenses with those same findings reported as associated with the Control contact lenses


Enrollment: 52
Study Start Date: May 2012
Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Daily Disposable Contact Lens Wear Device: Avaira Toric (enfilcon A) Soft Contact Lenses
The Test device is a contact lens manufactured by CooperVision, Inc.
Device: Acvuve Advance Toric (galyfilcon A) Soft Contact Lenses
The Control device is a contact lens manufactured by Johnson & Johnson Vision Care.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Prior to being considered eligible to participate in this study, each subject MUST:

  • Be at least 18 years of age as of the date of evaluation for the study.
  • Have read the Informed Consent, been given an explanation of the Informed Consent, indicated understanding of the Informed Consent, signed the Informed Consent document.
  • Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
  • Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An adapted full-time wearer is defined as wearing contact lenses in both eyes on a daily basis for at least 8 hours per day for at least one month prior to participation in the study.
  • Possess wearable and visually functional eyeglasses.
  • Be in good general health, based on his/her knowledge.
  • Require spectacle lens powers between -1.00 and -6.00 diopters sphere with no more than 2.00 diopters of refractive astigmatism and be willing to wear contact lenses in both eyes.
  • Have: manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 in each eye.
  • Upon completing the fitting process with the lenses to be worn in the study, have contact lens Snellen VA equal to or better than 20/30 in each eye.

Exclusion Criteria:

Subjects may not be enrolled in this study if any of the following apply: The subject is/has:

  • Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes. NOTE: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis.
  • Poor personal hygiene.
  • Any active participation in another clinical trial within 30 days prior to this study.
  • Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the study period.
  • A member, relative or household member of the investigator or of the investigational office staff.
  • Has a known sensitivity to ingredients used in the care products approved for use in the study.
  • Previous refractive surgery; or current or previous orthokeratology treatment.
  • Is aphakic or psuedophakic.
  • Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermia, keratoconus or type II diabetes.
  • The need for topical ocular medications or any medication which might interfere with contact lens wear or which would require the lenses to be removed during the day.
  • The presence of clinically significant (grade 3 or 4) anterior segment abnormalities.
  • Any; inflammations such as iritis; or any infection or allergic reaction of the eye, lids, or associated structures.
  • A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.
  • A history of papillary conjunctivitis that has interfered with contact lens wear.
  • Slit lamp findings that would contraindicate contact lens wear, including but not limited to: Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining > Grade 2, Pterygium, Corneal scars within the visual axis, Neovascularization or ghost vessels > 1.0 mm in from the limbus, Giant papillary conjunctivitis (GPC) of > Grade 1, Anterior uveitis or iritis, Seborrheic eczema, seborrheic conjunctivitis or blepharitis

To be eligible to be randomized for study product a subject must have ALL of the Inclusion Criteria and have NONE of the exclusion criteria present.

To be eligible for lens dispensing (either Test or Control), the subject's study lens contact lens visual acuity must be equal to or better than 20/30 in each eye.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706770

Locations
United States, California
Advanced Eyecare
Pismo Beach, California, United States, 93449
Eric M. White, OD, Inc.
San Diego, California, United States, 48823
United States, Michigan
Vision Care Associates
East Lansing, Michigan, United States, 48823
Sponsors and Collaborators
Coopervision, Inc.
Investigators
Principal Investigator: Scott E Schachter, OD Unafiliated
Principal Investigator: Cheryl Vincent-Reimer, OD Unafiliated
Principal Investigator: Eric White, OD Unafiliated
  More Information

No publications provided

Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01706770     History of Changes
Other Study ID Numbers: FC111216
Study First Received: October 5, 2012
Last Updated: August 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014