Clinical trial NCT02164396: Impact of Soft Contact Lenses on Lid-Parallel Conjunctival Folds
Official title: Impact of Soft Contact Lenses on Lid-Parallel Conjunctival Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lid-Parallel Conjunctival Folds
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to investigate how Lid-Parallel Conjunctival Folds recovers or persists after the continued usage or discontinuation of contact lenses or refitting with low coefficient of friction lenses.


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 18 years old.
4. The subject's contact lens correction must be in the range of -12.00 to +8.00 in each eye.
5. The subject's refractive cylinder must be less than 1.50D in each eye.
6. The subject must have best visual acuity of 20/40 or better in each eye.
7. The subject must demonstrate adequate mobility and 20/40 vision OD and OS with their habitual contact lenses.
8. The subject must be an adapted soft contact lens wearer in both eyes with at least 1 year experience in contact lens wear.
9. The subject must have normal eyes (i.e. no ocular medications or infections of any type).
10. The subject must have Lid-Parallel Conjunctival Folds greater than or equal to grade 1 OD or OS.

Exclusion Criteria:

1. Currently self reported 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. This may include, but not be limited to, ocular/systemic pathology or allergy known to affect the conjunctiva, Sjogren's Syndrome, rheumatoid arthritis, diabetes, infections, hay-fever, or if they have had ocular surgery.
3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
5. Any previous, or planned ocular or intra-ocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
6. 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 abnormality that may contraindicate contact lens wear.
7. Any ocular infection.
8. Monovision or multi-focal contact lens correction.
9. Participation in any contact lens or lens care product clinical trial within 90 days prior to study enrollment.
10. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV,by self report).
11. Employee of the investigational clinic (e.g. Investigator, Coordinator, Technician)
12. Contact lens wearing of OASYS or TruEye lenses
13. Contact lens wearing time less than 6h/day and/or 5 days/week
14. Extended wear of contact lenses.

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Primary outcomes:
measure: Lid-Parallel Conjunctival Folds (LIPCOF)
timeFrame: Baseline, 2-, 4-, 8- and 12-Week Follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Weinheim
country: Germany
Study officials:
References: