Evaluation of DW Silicone Hydrogel Lens Compared to DW Silicone Hydrogel Lens

The purpose of this study is to evaluate the performance of the investigational CooperVision silicone hydrogel lens compared to a currently-marketed silicone hydrogel contact lens up to 30 days of daily lens wear.

Study Overview

• Status: Terminated
• Conditions: Myopia
• Intervention / Treatment: Device: senfilcon A contact lens; Device: investigational enfilcon A

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9PL
    • University of Manchester
• United States
  • California
    • Berkeley, California, United States, 94704
      • Clinical Research Center, University of California, Berkeley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Be at least 18 years of age as of the date of evaluation for the study.
2. Not using any ocular medications
3. Have a self-reported full eye examination within 2 years.

4. Have:

   • read the Informed Consent
   • be given an explanation of the Informed Consent
   • indicate understanding of the Informed Consent
   • signed the Informed Consent document.
5. Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
6. Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An adapted full-time wearer is defined as wearing contact lenses on a daily basis for at least 8 hours per day for at least one month prior to participation in the study.
7. Possess wearable and visually functional eyeglasses.
8. Be in good general health, based on his/her knowledge.
9. Require spectacle lens powers between -1.00 and -6.00 diopters sphere with no more than 0.75 diopter of refractive astigmatism in order to have the best spherical equivalent power of -6.50 or less.
10. Be willing to wear contact lenses in both eyes.
11. Have manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 (less than or equal to LogMAR 0.10) in each eye.
12. 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:

1. 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.
2. Any active participation in another one-day clinical trial within 7 days prior to this study or another dispensing trial within 30 days prior to this study.
3. Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next month.
4. Has a known sensitivity to ingredients used in the over the counter contact lens care approved for use in the study.
5. Previous refractive surgery/anterior segment surgery; or current or previous orthokeratology treatment or irregular cornea.
6. Is aphakic or pseudophakic.
7. Unable to achieve a satisfactory fit with the lens designs used in the study
8. 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.
9. The need for topical ocular medications or any medication which might contradict contact lens wear or which would require the lenses to be removed during the day.
10. The presence of clinically anterior segment infection, inflammations or abnormalities; such as iritis; or any infection of the eye, lids, or associated structures.
11. A history of herpetic keratitis.
12. A known history of corneal hypoesthesia (reduced corneal sensitivity) or active corneal ulcer, corneal infiltrates or fungal infection.
13. A history of papillary conjunctivitis that has interfered with contact lens wear.

14. 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
    • Corneal edema or corneal staining ≥ grade 2
    • Neovascularization or ghost vessels > 1.0 mm in from the limbus
    • Giant papillary conjunctivitis (GPC) of > grade 2.
    • Seborrheic eczema, seborrheic conjunctivitis or blepharitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: enfilcon A + senofilcon A; Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other	Device: senfilcon A contact lens; senofilcon A spherical contact lens worn in a daily wear modality; Device: investigational enfilcon A; investigational enfilcon A, worn daily wear modality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Comfort Preference - Participants Preference Response	Subjective responses of participants administered by questionnaire and measured on a linear scale (0-100) measured at each visit.	V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)
Ocular Health	Ocular health determined by biomicroscopy recorded on a severity scale (0-4) for change from baseline over 30 days.	Change from baseline over 30 days measured at V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator Surface Preference	Investigator Surface Preference rated on a linear scale (Lens assessment biomicroscopy: 1=strong R, 2=slight R, 3=No Pref, 4=slight L, 5=strong L)	V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)
Investigator Fit Preference	Investigator Fit Preference rated on a linear scale (Lens assessment biomicroscopy: 1=strong R, 2=slight R, 3=No Pref, 4=slight L, 5=strong L)	V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)

Collaborators and Investigators

• Sponsor: CooperVision, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: May 22, 2011
• First Submitted That Met QC Criteria: June 29, 2011
• First Posted (Estimate): June 30, 2011

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CV-10-50

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes