Lid-Parallel Conjunctival FoldsNCT02164396
Impact of Soft Contact Lenses on Lid-Parallel Conjunctival Folds
A study testing Spectacle Lens, Habitual Soft Contact Lens and Test Lens in people with Lid-Parallel Conjunctival Folds, run by Johnson & Johnson Vision Care, Inc. at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lid-Parallel Conjunctival Folds
- What is being tested?
- Spectacle Lens, Habitual Soft Contact Lens and Test Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lid-Parallel Conjunctival Folds
- Being tested
- Spectacle Lens, Habitual Soft Contact Lens, Test Lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectacle LensDevice
Spectacle Lens Only
Habitual Soft Contact LensDevice
subject's own contact lens
Test LensDevice
senofilcon A or narafilcon A
| Study group | Role | What they receive |
|---|---|---|
| Spectacles Lens | Active comparator | 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. Receives: Device: Spectacle Lens |
| Habitual Soft Contact Lens | Active comparator | 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. Receives: Device: Habitual Soft Contact Lens |
| Test Lens | Experimental | Participants will be dispensed senofilcon A or narafilcon A depending on their habitual modality (reusable or daily disposable) Receives: Device: Test Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 2-, 4-, 8- and 12-Week Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lid-Parallel Conjunctival FoldsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164396
- Sponsor's protocol ID
- CR-005277
- Status last verified
- Oct 2016
- First submitted
- 2 May 2013
- Last updated
- 19 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Soft Contact Lenses on Lid-Parallel Conjunctival Folds
- ClinicalTrials.gov ID
- NCT02164396
- Acronym / sponsor ID
- CR-005277
- Conditions
- Lid-Parallel Conjunctival Folds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 16 Jun 2014 (estimated)
- Results
- Posted 5 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spectacles Lens | Active comparator | Device: Spectacle LensParticipant 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. |
| Habitual Soft Contact Lens | Active comparator | Device: Habitual Soft Contact LensParticipant 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. |
| Test Lens | Experimental | Device: Test LensParticipants will be dispensed senofilcon A or narafilcon A depending on their habitual modality (reusable or daily disposable) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectacle LensSpectacle Lens Only | Device | Spectacles Lens |
| Habitual Soft Contact Lenssubject's own contact lens | Device | Habitual Soft Contact Lens |
| Test Lenssenofilcon A or narafilcon A | Device | Test Lens |
Primary outcome
Lid-Parallel Conjunctival Folds (LIPCOF)
Time frame: Baseline, 2-, 4-, 8- and 12-Week Follow-up
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectacle Lens, Habitual Soft Contact Lens and Test Lens in people with Lid-Parallel Conjunctival Folds, run by Johnson & Johnson Vision Care, Inc. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lid-Parallel Conjunctival Folds (LIPCOF) (time frame: Baseline, 2-, 4-, 8- and 12-Week Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.