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

NCT01386008 | Terminated Results FDA Device

• 1 other identifier: CV-10-50
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Investigator Surface Preference

  V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)

• Investigator Fit Preference

  V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)

Study Arms (1)

enfilcon A + senofilcon A

OTHER

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; Device: investigational enfilcon A

Interventions

senfilcon A contact lens DEVICE

senofilcon A spherical contact lens worn in a daily wear modality

enfilcon A + senofilcon A

investigational enfilcon A DEVICE

investigational enfilcon A, worn daily wear modality

enfilcon A + senofilcon A

Eligibility Criteria

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

You may qualify if:

• Be at least 18 years of age as of the date of evaluation for the study.
• Not using any ocular medications
• Have a self-reported full eye examination within 2 years.
• Have:
• read the Informed Consent
• be given an explanation of the Informed Consent
• indicate 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 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 0.75 diopter of refractive astigmatism in order to have the best spherical equivalent power of -6.50 or less.
• Be willing to wear contact lenses in both eyes.
• 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.

You may not qualify if:

• 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.
• 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.
• Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next month.
• Has a known sensitivity to ingredients used in the over the counter contact lens care approved for use in the study.
• Previous refractive surgery/anterior segment surgery; or current or previous orthokeratology treatment or irregular cornea.
• Is aphakic or pseudophakic.
• Unable to achieve a satisfactory fit with the lens designs used in the study
• 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 contradict contact lens wear or which would require the lenses to be removed during the day.
• The presence of clinically anterior segment infection, inflammations or abnormalities; such as iritis; or any infection of the eye, lids, or associated structures.
• A history of herpetic keratitis.
• A known history of corneal hypoesthesia (reduced corneal sensitivity) or active corneal ulcer, corneal infiltrates or fungal infection.
• 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

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (2)

Clinical Research Center, University of California, Berkeley

Berkeley, California, 94704, United States

Location

University of Manchester

Manchester, M13 9PL, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Limitations and Caveats

Incomplete data sets / Data not analyzed / Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up.

Results Point of Contact

• Title: Meng Lin, OD, PhD
• Organization: Clinical Research Center (CRC) UC Berkeley School of Optometry

(510) 642-9731

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: May 22, 2011
• First Posted: June 30, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: September 4, 2019
• Results First Posted: March 21, 2014

Record last verified: 2019-08

Locations

GB (1); US (1)