Refractive ErrorsNCT01444313
Prospective Study of the Health Benefits of Ultra-Violet Filtering Contact Lenses
A study testing narafilcon A contact lens and nelfilcon A soft contact lenses in people with Refractive Errors, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to examine the short-term protective effect of Ultra-Violet filtering contact lenses on macular pigment ocular density. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Errors
- What is being tested?
- narafilcon A contact lens and nelfilcon A soft contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is an adapted soft contact lens wearer
- The subject's spherical error equivalent (Best Sphere corrected for back vertex distance) must be from -0.50 diopters (D) to -6.00D or from +0.50D to +4.00D in each eye
- The subject must have a refractive astigmatism in each eye of -0.75D or less
- The subject must have a best corrected visual acuity of 6/9 or better in each eye.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol
- The subject must read and sign the statement of informed consent
- The subject must be at least 18 years of age
Who cannot join
- Systemic or ocular allergies which might interfere with contact lens wear
- Systemic disease which might interfere with contact lens wear
- Ocular disease which might interfere with contact lens wear
- Grade 3 or 4 Slit Lamp Findings
- Greater than 0.1 difference in macular pigment optical density (MPOD) findings between right and left eye at baseline visit
- On changing stable medication or taking any medication known to affect tear film
Show all 16Show fewer
- Active ocular surface pathology
- Use ocular medication
- Had had any anterior ocular surgery or other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study
- Significant ocular tissue anomaly
- Presence of two or more corneal scars in either eye
- Pregnancy or lactation, or intends to become pregnant during the time period of the study
- Any medical condition that may be prejudicial to the study
- Diabetes
- Infectious diseases (e.g. Hepatitis, tuberculosis)
- Contagious immunosuppressive diseases (e.g. HIV)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the short-term protective effect of Ultra-Violet filtering contact lenses on macular pigment ocular density.
- Conditions
- Refractive Errors
- Being tested
- narafilcon A contact lens, nelfilcon A soft contact lenses
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
narafilcon A contact lensDevice
Soft contact lenses with UV protection
nelfilcon A soft contact lensesDevice
Soft contact lenses without UV protection
| Study group | Role | What they receive |
|---|---|---|
| nelfilcon A OD / narafilcon A OS | Other | Soft contact lens without UV protection worn on the right eye (OD) and soft contact lens with UV protection worn on the left eye (OS). Receives: Device: narafilcon A contact lens; Device: nelfilcon A soft contact lenses |
| narafilcon A OD / nelfilcon A OS | Other | Soft contact lens with UV protection worn on the right eye (OD) and soft contact lens without UV protection worn on the left eye (OS). Receives: Device: narafilcon A contact lens; Device: nelfilcon A soft contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular Pigment Optical Density at 9 months
Measured: baseline to 9 months
Macular Pigment Optical Density at 15 months
Measured: baseline to 15 months
Secondary outcomes (3)
Macular Pigment Optical Density at 3 months
Measured: baseline to 3 months
Macular Pigment Optical Density at 6 months
Measured: baseline to 6 months
Macular Pigment Optical Density at 12 months
Measured: baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 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
- NCT01444313
- Sponsor's protocol ID
- CR-201009
- Status last verified
- Oct 2014
- First submitted
- 30 Aug 2011
- Last updated
- 19 Jun 2018
- Results posted
- 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
- Prospective Study of the Health Benefits of Ultra-Violet Filtering Contact Lenses
- ClinicalTrials.gov ID
- NCT01444313
- Acronym / sponsor ID
- CR-201009
- Conditions
- Refractive Errors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Mar 2013 (actual)
- First posted
- 30 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the short-term protective effect of Ultra-Violet filtering contact lenses on macular pigment ocular density.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nelfilcon A OD / narafilcon A OS | Other | Device: narafilcon A contact lens, Device: nelfilcon A soft contact lensesSoft contact lens without UV protection worn on the right eye (OD) and soft contact lens with UV protection worn on the left eye (OS). |
| narafilcon A OD / nelfilcon A OS | Other | Device: narafilcon A contact lens, Device: nelfilcon A soft contact lensesSoft contact lens with UV protection worn on the right eye (OD) and soft contact lens without UV protection worn on the left eye (OS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subject is an adapted soft contact lens wearer
- The subject's spherical error equivalent (Best Sphere corrected for back vertex distance) must be from -0.50 diopters (D) to -6.00D or from +0.50D to +4.00D in each eye
- The subject must have a refractive astigmatism in each eye of -0.75D or less
- The subject must have a best corrected visual acuity of 6/9 or better in each eye.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol
Key exclusion criteria (16 listed)
- Systemic or ocular allergies which might interfere with contact lens wear
- Systemic disease which might interfere with contact lens wear
- Ocular disease which might interfere with contact lens wear
- Grade 3 or 4 Slit Lamp Findings
- Greater than 0.1 difference in macular pigment optical density (MPOD) findings between right and left eye at baseline visit
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 |
|---|---|---|
| narafilcon A contact lensSoft contact lenses with UV protection | Device | narafilcon A OD / nelfilcon A OS, nelfilcon A OD / narafilcon A OS |
| nelfilcon A soft contact lensesSoft contact lenses without UV protection | Device | narafilcon A OD / nelfilcon A OS, nelfilcon A OD / narafilcon A OS |
Primary outcome
Macular Pigment Optical Density at 9 months
Time frame: baseline to 9 months
Macular Pigment Optical Density at 15 months
Time frame: baseline to 15 months
3 secondary outcomes
Macular Pigment Optical Density at 3 months
Time frame: baseline to 3 months
Macular Pigment Optical Density at 6 months
Time frame: baseline to 6 months
Macular Pigment Optical Density at 12 months
Time frame: baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
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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 narafilcon A contact lens and nelfilcon A soft contact lenses in people with Refractive Errors, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.
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 7 inclusion and 16 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Macular Pigment Optical Density at 9 months (time frame: baseline to 9 months). The study lists 2 primary outcomes in all. 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.