Clinical trial NCT01093625: Assessment of Daily Disposable Silicone Hydrogel Lens Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Ohio State University
First posted: 2010-03-26
Enrollment: 157
Sex: ALL
Minimum age (years): 15
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of an investigational silicone hydrogel soft contact lens on new contact lens wearers (neophytes) compared to a control of spectacle wearers.


Eligibility criteria: Inclusion Criteria:

* Able to read, comprehend and sign an informed consent (or parental consent/subject assent, as appropriate).
* Willing to comply with the study visit schedule.
* Ages 15 to 39.
* Has access to a cellular telephone with text messaging capabilities.
* Has a current pair of spectacles.
* 'Neophyte' - In this work, 'neophyte' will be taken to mean any subject who has never been dispensed contact lenses. A subject who has taken part in a non-dispensing clinical study or has been fitted with contact lenses in practice but never went on to actually wear the lenses, will also be classified as a 'neophyte'.
* Spherical contact lens (CL) prescription between -0.75D and -6.00D and spectacle cylinder equal to or less than 0.75 DC.
* Monocular best-corrected distance visual acuity (VA) ≥ 20/30 Snellen in each eye.
* Subject agrees to "intent" of wearing the CLs at minimum 6 hours/day for at least 4 days per week.
* They agree not to participate in other clinical research during the duration of this study.

Exclusion Criteria:

* Active ocular allergy, infection, injury, inflammation, or abnormality (e.g., keratoconus) that might interfere with soft contact lens wear.
* Prior corneal refractive surgery or corneal irregularity (e.g., keratoconus).
* Systemic disease, which might interfere with contact lens wear.
* Medication usage that may be associated with eye dryness.
* Use of any topical medication such as eye drops or ointment.
* Pregnant or lactating (by self-report).
* Aphakia.
* Grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear.
* Have participated in any other clinical trial or research in the two weeks prior to starting this study.

Primary outcomes:
measure: Papillary Conjunctivitis
timeFrame: 1 Year
measure: Conjunctival Hyperemia
timeFrame: 1 Year
measure: Limbal Hyperemia
timeFrame: 1 Year
measure: Corneal Staining
timeFrame: 1 Year
measure: Conjunctival Staining
timeFrame: 1 Year
measure: Corneal Neovascularization
timeFrame: 1 Year
measure: Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire
timeFrame: 1 Year
Secondary outcomes:
measure: Comfortable Wearing Time
timeFrame: 1 Year
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
References: