Refractive ErrorsNCT01444053
Retrospective Study of the Health Benefits of Ultra-Violet Filtering Contact Lenses
An observational study of 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 long term effect of ultra-violet filtering contact lenses on macular pigment density (MPOD) and accommodative function. Read more about this study
- Who is it for?
- Ages 18 to 43 years
- Conditions the study is for
- Refractive Errors
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2011to 1 Dec 2011
- Phase
- Observational
- 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 to 43 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subject selection is based on a history of wearing one of two types of contact lenses for at least five years. Age-matching subjects into 4 age-brackets will be attempted with a target of five subjects in each age bracket among the two types of lenses.
Who may be able to join
- The subject is an adapted soft contact lens wearer of at least 5 years duration of either an UV filtering contact lens or a non-UV filtering contact lens
- The subject must report wearing their contact lenses, on average, for a minimum of 5 days each week.
- The subject must have best corrected visual acuity of 6/7.5 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 between 18 and 43 years of age
Who cannot join
- On medication known to affect accommodation
- Active ocular surface pathology
- Had eye surgery
- Significant ocular tissue anomaly
- Any medical condition that may be prejudicial to the study
- Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the long term effect of ultra-violet filtering contact lenses on macular pigment density (MPOD) and accommodative function.
- Conditions
- Refractive Errors
- Being tested
- No Intervention
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionDevice
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Wearers of contact lenses without UV Protection | Subjects who have worn a soft contact lens without UV protection for the past five years or more. Receives: Device: No Intervention | |
| Wearers of contact lenses with UV Protection | Subjects who have worn a soft contact lens with UV protection for the last 5 years or more. Receives: Device: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular Pigment Optical Density (MPOD) after 5 years of contact lens wear
The MPOD will be assessed at a single visit will be compared between wearers of contact lenses with UV protection and those wearers of lenses without UV protection, based on their 5 year wear history.
Measured: Approximately 40 minutes
Amplitude of Accommodation after 5 years of contact lens wear
Measured with autorefractor at a single visit and will be compared between wearers of contact lenses with UV protection and those wearers of lenses without UV protection, based on their 5 year wear history.
Measured: Approximately 40 minutes
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 start1 Jun 2011
- Primary completion1 Dec 2011
- Study completion1 Dec 2011
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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 41 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
- NCT01444053
- Sponsor's protocol ID
- CR-201010
- Status last verified
- Jun 2017
- First submitted
- 30 Aug 2011
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of the Health Benefits of Ultra-Violet Filtering Contact Lenses
- ClinicalTrials.gov ID
- NCT01444053
- Acronym / sponsor ID
- CR-201010
- Conditions
- Refractive Errors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2011 (actual)
- Primary completion
- 1 Dec 2011 (actual)
- Study completion
- 1 Dec 2011 (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 long term effect of ultra-violet filtering contact lenses on macular pigment density (MPOD) and accommodative function.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wearers of contact lenses without UV Protection | – | Device: No InterventionSubjects who have worn a soft contact lens without UV protection for the past five years or more. |
| Wearers of contact lenses with UV Protection | – | Device: No InterventionSubjects who have worn a soft contact lens with UV protection for the last 5 years or more. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subject selection is based on a history of wearing one of two types of contact lenses for at least five years. Age-matching subjects into 4 age-brackets will be attempted with a target of five subjects in each age bracket among the two types of lenses.
Key inclusion criteria (6 listed)
- The subject is an adapted soft contact lens wearer of at least 5 years duration of either an UV filtering contact lens or a non-UV filtering contact lens
- The subject must report wearing their contact lenses, on average, for a minimum of 5 days each week.
- The subject must have best corrected visual acuity of 6/7.5 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
Key exclusion criteria (6 listed)
- On medication known to affect accommodation
- Active ocular surface pathology
- Had eye surgery
- Significant ocular tissue anomaly
- Any medical condition that may be prejudicial to the study
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 |
|---|---|---|
| No InterventionNo Intervention | Device | Wearers of contact lenses with UV Protection, Wearers of contact lenses without UV Protection |
Primary outcome
Macular Pigment Optical Density (MPOD) after 5 years of contact lens wear
Time frame: Approximately 40 minutes
The MPOD will be assessed at a single visit will be compared between wearers of contact lenses with UV protection and those wearers of lenses without UV protection, based on their 5 year wear history.
Amplitude of Accommodation after 5 years of contact lens wear
Time frame: Approximately 40 minutes
Measured with autorefractor at a single visit and will be compared between wearers of contact lenses with UV protection and those wearers of lenses without UV protection, based on their 5 year wear history.
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 20 Jun 2017.
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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?
An observational study of 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 6 inclusion and 6 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 20 Jun 2017. 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 (MPOD) after 5 years of contact lens wear (time frame: Approximately 40 minutes). 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 20 Jun 2017.