N/A
N=30
Clinical Evaluation of An Approved Contact Lens
Tear Film Characteristics
Bottom Line
View on ClinicalTrials.gov: NCT02760810 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Tear Film Osmolarity — 293.4 mOsm/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Marketed Contact Lens (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tear Film Osmolarity |
294.4 | — |
| SECONDARY Tear Film Osmolarity |
294.4 | — |
| SECONDARY Tear Film PH |
6.86 | — |
Summary
This is an 8-visit, bilateral, dispensing clinical study to evaluate the change in tear fluid pH and tear film osmolarity in an FDA-cleared contact lens in new contact lens users over a 14-day period.
Eligibility Criteria
Inclusion Criteria
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject must be between 18 and 45 years of age.
- The subject must have a valid spectacle prescription with expiration date not over 1 year.
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.25 Diopters (D) to -6.00 D in each eye.
- The subject's refractive cylinder must be ≤1.00 Cylindrical Diopter (DC) in each eye.
- The subject must have best corrected visual acuity of logMAR 0.20 or better in each eye.
- Subjects should own a wearable pair of spectacles and agree to wear them the day of the initial visit and every morning on subsequent visit days.
- The subject must be a contact lens neophyte, defined as never having been dispensed contact lenses, or 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.
- The subject must have normal eyes (i.e. no ocular medications or infections of any type).
Exclusion Criteria
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
- Use of any medication with known tear film effects within 2 weeks prior to and during the study.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion..
- Any previous, or planned, ocular or interocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
- Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g. past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
- Any ocular infection.
- Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
- Employee of investigational clinic (e.g. Investigator, Coordinator, Technician).
Data sourced from ClinicalTrials.gov (NCT02760810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.