- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02164396
Impact of Soft Contact Lenses on Lid-Parallel Conjunctival Folds
June 18, 2018 updated by: Johnson & Johnson Vision Care, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Weinheim, Germany, 69469
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Spectacles Lens
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.
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Spectacle Lens Only
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Active Comparator: Habitual Soft Contact Lens
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.
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subject's own contact lens
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Experimental: Test Lens
Participants will be dispensed senofilcon A or narafilcon A depending on their habitual modality (reusable or daily disposable)
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senofilcon A or narafilcon A
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lid-Parallel Conjunctival Folds (LIPCOF)
Time Frame: Baseline, 2-, 4-, 8- and 12-Week Follow-up
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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).
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Baseline, 2-, 4-, 8- and 12-Week Follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
May 2, 2013
First Submitted That Met QC Criteria
June 12, 2014
First Posted (Estimate)
June 16, 2014
Study Record Updates
Last Update Posted (Actual)
June 19, 2018
Last Update Submitted That Met QC Criteria
June 18, 2018
Last Verified
October 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- CR-005277
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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