Impact of Soft Contact Lenses on Lid-Parallel Conjunctival Folds

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Soft Contact Lenses on Lid-Parallel Conjunctival Folds

Conditions
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Lid-Parallel Conjunctival Folds

Intervention / Treatment
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* Device: Spectacle Lens
* Device: Habitual Soft Contact Lens
* Device: Test Lens


Participation Criteria
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Eligibility Criteria
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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 18 years old. The subject's contact lens correction must be in the range of -12.00 to +8.00 in each eye. The subject's refractive cylinder must be less than 1.50D in each eye. The subject must have best visual acuity of 20/40 or better in each eye. The subject must demonstrate adequate mobility and 20/40 vision OD and OS with their habitual contact lenses. The subject must be an adapted soft contact lens wearer in both eyes with at least 1 year experience in contact lens wear. The subject must have normal eyes (i.e. no ocular medications or infections of any type). The subject must have Lid-Parallel Conjunctival Folds greater than or equal to grade 1 OD or OS. Exclusion Criteria: Currently self reported 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. 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. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry. Any previous, or planned ocular or intra-ocular surgery (e.g. radial keratotomy, PRK, 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 abnormality that may contraindicate contact lens wear. Any ocular infection. Monovision or multi-focal contact lens correction. Participation in any contact lens or lens care product clinical trial within 90 days prior to study enrollment. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV,by self report). Employee of the investigational clinic (e.g. Investigator, Coordinator, Technician) Contact lens wearing of OASYS or TruEye lenses Contact lens wearing time less than 6h/day and/or 5 days/week Extended wear of contact lenses. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spectacles Lens<br>Participant will discontinue soft contact lens wear and wear spectacles only. Spectacle lens refers to the habitual prescription glasses that the participant arrives to the testing center with; they are NOT prescribed or given to the participant by the investigator as part of the study protocol. | Device: Spectacle Lens<br>* Spectacle Lens Only<br>|
| Active Comparator: Habitual Soft Contact Lens<br>Participant will continue to wear their habitual soft contact lenses. Habitual lenses are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation. | Device: Habitual Soft Contact Lens<br>* subject's own contact lens<br>|
| Experimental: Test Lens<br>Participants will be dispensed senofilcon A or narafilcon A depending on their habitual modality (reusable or daily disposable) | Device: Test Lens<br>* senofilcon A or narafilcon A<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lid-Parallel Conjunctival Folds (LIPCOF) | LIPCOF was assessed at baseline to 2-, 4-, 8- and 12- week Follow-up. Each subject eye was graded using a 4- point using the scale (Grade 0: No conjunctival folds, Grade 1: One permanent and clear parallel fold, Grade 2: Two permanent and clear parallel folds, (normally lower than 0.2mm) and Grade 3: More than two permanent and clear parallel folds, (normally higher than 0.2mm) at two 2 locations in the eye (Temporal and Nasal). The graded responses for each location (Temporal and Nasal) was average. The sum of the average LIPCOF grade for Temporal and Nasal was reported. (Score=average Nasal Grade + average Temporal Grade). | Baseline, 2-, 4-, 8- and 12-Week Follow-up |