Clinical trial NCT01386008: Evaluation of DW Silicone Hydrogel Lens Compared to DW Silicone Hydrogel Lens
Official title: Evaluation of DW Silicone Hydrogel Lens Compared to DW Silicone Hydrogel Lens
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2011-06-30
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Subjective Comfort Preference - Participants Preference Response
timeFrame: V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)
measure: Ocular Health
timeFrame: Change from baseline over 30 days measured at V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)
Secondary outcomes:
measure: Investigator Surface Preference
timeFrame: V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)
measure: Investigator Fit Preference
timeFrame: V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Clinical Research Center, University of California, Berkeley
state: California
city: Manchester
country: United Kingdom
facility: University of Manchester
Study officials:
References: