Clinical trial NCT02760810: Clinical Evaluation of An Approved Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tear Film Characteristics
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2016-05-04
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. The subject must be between 18 and 45 years of age.
4. The subject must have a valid spectacle prescription with expiration date not over 1 year.
5. 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.
6. The subject's refractive cylinder must be ≤1.00 Cylindrical Diopter (DC) in each eye.
7. The subject must have best corrected visual acuity of logMAR 0.20 or better in each eye.
8. 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.
9. 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.
10. The subject must have normal eyes (i.e. no ocular medications or infections of any type).

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
4. Use of any medication with known tear film effects within 2 weeks prior to and during the study.
5. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion..
6. Any previous, or planned, ocular or interocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
7. 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.
8. Any ocular infection.
9. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report.
10. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
11. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
12. Employee of investigational clinic (e.g. Investigator, Coordinator, Technician).

Primary outcomes:
measure: Tear Film Osmolarity
timeFrame: 2-Week Follow-up
Secondary outcomes:
measure: Tear Film Osmolarity
timeFrame: 1-Week Follow-up
measure: Tear Film PH
timeFrame: 1-Week Follow-up
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Aston University
state: West Midlands
Study officials:
References: