CompletedNot Applicable

Clinical Evaluation of An Approved Contact Lens

United Kingdom31 participantsStarted 2016-04-12

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

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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.

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.

What they're measuring

Tear Film Osmolarity

Timeframe: 2-Week Follow-up

Trial details

NCT IDNCT02760810

SponsorJohnson & Johnson Vision Care, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-04-26

Results submitted2017-05-01

View on ClinicalTrials.gov More Tear Film Characteristics trials