Evaluation of Enfilcon A Soft Contact Lens When Compared to Galyfilcon A Soft Contact Lens

NCT01706770 | Completed Results DMC FDA Device

• 1 other identifier: FC111216
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Ametropia

Outcome Measures

Primary Outcomes (2)

• Objective Assessment: Ocular Response - Biomicroscopy

  The primary safety endpoint are the objective slit lamp findings associated with the enfilcon A contact lenses compared with those same findings reported as associated with the galyfilcon A contact lenses. The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline/Dispensing (baseline and dispensing visit combined), Post-Dispensing (after lenses were dispensed and allowed to settle) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit combined). The average grade for unique eyes with findings greater than 0 (none) is compared.

  Change from baseline/dispensing visits, post-dispensing visit and all follow-ups visits

• Comparison of Objective Findings - Number of Adverse Events in Unique Eyes

  The primary safety endpoint are the objective findings of the number of adverse events in unique eyes associated with the enfilcon A contact lenses compared with those same findings as associated with the galyfilcon A contact lenses. The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence from Baseline through end of month 1 visit.

  Any occurrence from baseline to 1 month visit

Study Arms (2)

enfilcon A

EXPERIMENTAL

The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.

Device: enfilcon A

galyfilcon A

ACTIVE COMPARATOR

The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.

Device: galyfilcon A

Interventions

enfilcon A DEVICE

Also known as: Avaira® Toric

enfilcon A

galyfilcon A DEVICE

Also known as: Acvuve® Advance®

galyfilcon A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (3)

Advanced Eyecare

Pismo Beach, California, 93449, United States

Location

Eric M. White, OD, Inc.

San Diego, California, 48823, United States

Location

Vision Care Associates

East Lansing, Michigan, 48823, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: William J. Gleason, O.D.
• Organization: Foresight Regulatory Strategies, Inc.

(978) 658-6888

Study Officials

• Scott E Schachter, OD

  Unafiliated

  PRINCIPAL INVESTIGATOR

• Cheryl Vincent-Reimer, OD

  Unafiliated

  PRINCIPAL INVESTIGATOR

• Eric White, OD

  Unafiliated

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2012
• First Posted: October 15, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 5, 2020
• Results First Posted: April 29, 2014

Record last verified: 2020-09

Locations

US (3)