MyopiaNCT01912768

Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers

A study testing FID 120947A contact lens disinfecting solution, renu fresh multi-purpose solution and Soft contact lenses in people with Myopia and Astigmatism, run by Alcon Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is demonstrate substantial equivalence of an investigational contact lens disinfecting solution to a commercially available contact lens solution in silicone hydrogel and soft contact lens wearers. Read more about this study

Who is it for?: Any age
Conditions the study is for: Myopia, Astigmatism, Hyperopia
What is being tested?: FID 120947A contact lens disinfecting solution, renu fresh multi-purpose solution and Soft contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 362 participants
Where: No sites listed yet
Study dates: Dec 2013to May 2014
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Normal eyes (other than correction for visual acuity);
Successful history of silicone hydrogel or soft contact lens wear in both eyes in one of the following brands: Soflens® 38, Proclear DW, Frequency 55, Acuvue® Oasys™, Air Optix Aqua, O2 OPTIX, Air Optix for Astigmatism, Air Optix Aqua Multifocal, Biofinity®, PureVision®, PureVision®2;
Best spectacle corrected distance visual acuity greater than or equal to 20/25 in each eye;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the investigational products or affect the results of this study;
Need to wear contact lenses on an extended wear basis (ie, overnight) during the study;
Use of a daily cleaner and/or an enzyme cleaner to care for lenses at least 7 days prior to Visit 1;
History of intolerance or hypersensitivity to any component of the investigational products;
Use of all over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1;
Moderate, severe, abnormal, or other ocular findings;

Show all 11Show fewer

Current or history of ocular infection, severe inflammation, or disease within 6 months prior to Visit 1;
Any systemic disease at Visit 1 (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions;
Use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen;
Ocular surgery within the last 12 months;
Other protocol-defined exclusion criteria may apply.

About this study

Official title: Clinical Evaluation of the Safety and Efficacy of FID 120947A Compared to a Marketed Lens Care Solution

Read the detailed description

Subjects with normal eyes (other than correction for refractive error) successfully wearing soft contact lenses were randomized 2:1 to receive either the investigational or commercial contact lens solution for daily use throughout the study (90 days).

Conditions: Myopia, Astigmatism, Hyperopia, Refractive Error
Being tested: FID 120947A contact lens disinfecting solution, renu fresh multi-purpose solution, Soft contact lenses
Keywords: contact lenses, contact lens solution, soft contact lenses
Medical subject headings: Myopia, Astigmatism, Hyperopia, Refractive Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FID 120947A contact lens disinfecting solutionDevice
Also called Clear Care® Plus
Investigational 3% hydrogen peroxide solution intended for simultaneous cleaning, protein removal, disinfecting and storage of silicone hydrogel and soft contact lenses
renu fresh multi-purpose solutionDevice
Commercially available solution indicated for cleaning, removing protein deposits, rinsing, chemical disinfection, and storage of soft contact lenses
Soft contact lensesDevice
Commercially available soft contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (90 days). A fresh pair will be dispensed on Day 0, Day 30, and Day 60.

Study groups in NCT01912768
Study group	Role	What they receive
FID 120947A	Experimental	FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days Receives: Device: FID 120947A contact lens disinfecting solution; Device: Soft contact lenses
renu fresh	Active comparator	Renu fresh multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days Receives: Device: renu fresh multi-purpose solution; Device: Soft contact lenses

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects With Visibly Clean Lenses
Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. One eye (study eye) contributed to the analysis.
Measured: Day 7, Day 30, Day 60, Day 90
Percentage of Subjects With Crystalline Deposits by Type
Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.
Measured: Day 7, Day 30, Day 60, Day 90
Percentage of Subjects With Film Deposits by Type
Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.
Measured: Day 7, Day 30, Day 60, Day 90
Average Residual Lens Lysozyme
Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 μg or 0 μg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis.
Measured: Day 30/Early Exit
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis.
Measured: Baseline (Day 0), Day 7, Day 30, Day 60, Day 90
Average Lens Wear Time
Subject recorded a response to the question, "Averaging over the last 3 days, how many hours per day did you wear your contact lenses?" Lens wear time was measured in hours.
Measured: Day 7, Day 30, Day 60, Day 90
Number of Unscheduled Lens Replacements by Reason
A fresh pair of lenses was dispensed on Day 0, Day 30, and Day 60. Lenses replaced at other times were considered unscheduled. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject.
Measured: Up to Day 90
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.
Measured: Day 7, Day 30, Day 60, Day 90
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.
Measured: Day 7, Day 30, Day 60, Day 90
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.
Measured: Day 7, Day 30, Day 60, Day 90
Crystalline Deposit Area Covered
Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.
Measured: Day 7, Day 30, Day 60, Day 90
Film Deposit Area Covered
Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.
Measured: Day 7, Day 30, Day 60, Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2013May 2014

First posted31 Jul 2013 (estimated)
Study startDec 2013
Primary completionMay 2014
Study completionMay 2014

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 MyopiaStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 362 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01912768
Sponsor's protocol ID: C-13-003
Status last verified: Jun 2015
First submitted: 29 Jul 2013
Last updated: 9 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of the Safety and Efficacy of FID 120947A Compared to a Marketed Lens Care Solution
ClinicalTrials.gov ID: NCT01912768
Acronym / sponsor ID: C-13-003
Conditions: Myopia, Astigmatism, Hyperopia, Refractive Error
Keywords: contact lenses, contact lens solution, soft contact lenses
Study type: Interventional
Recruitment status: Completed
Enrolment: 362 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Dec 2013
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 31 Jul 2013 (estimated)
Results: Posted 9 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
FID 120947A	Experimental	Device: FID 120947A contact lens disinfecting solution, Device: Soft contact lensesFID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
renu fresh	Active comparator	Device: renu fresh multi-purpose solution, Device: Soft contact lensesRenu fresh multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Normal eyes (other than correction for visual acuity);
Successful history of silicone hydrogel or soft contact lens wear in both eyes in one of the following brands: Soflens® 38, Proclear DW, Frequency 55, Acuvue® Oasys™, Air Optix Aqua, O2 OPTIX, Air Optix for Astigmatism, Air Optix Aqua Multifocal, Biofinity®, PureVision®, PureVision®2;
Best spectacle corrected distance visual acuity greater than or equal to 20/25 in each eye;
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (11 listed)

Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the investigational products or affect the results of this study;
Need to wear contact lenses on an extended wear basis (ie, overnight) during the study;
Use of a daily cleaner and/or an enzyme cleaner to care for lenses at least 7 days prior to Visit 1;
History of intolerance or hypersensitivity to any component of the investigational products;
Use of all over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1;

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
FID 120947A contact lens disinfecting solutionAlso: Clear Care® PlusInvestigational 3% hydrogen peroxide solution intended for simultaneous cleaning, protein removal, disinfecting and storage of silicone hydrogel and soft contact lenses	Device	FID 120947A
renu fresh multi-purpose solutionCommercially available solution indicated for cleaning, removing protein deposits, rinsing, chemical disinfection, and storage of soft contact lenses	Device	renu fresh
Soft contact lensesCommercially available soft contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (90 days). A fresh pair will be dispensed on Day 0, Day 30, and Day 60.	Device	FID 120947A, renu fresh

Primary outcome

Percentage of Subjects With Visibly Clean Lenses
Time frame: Day 7, Day 30, Day 60, Day 90
Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. One eye (study eye) contributed to the analysis.
Percentage of Subjects With Crystalline Deposits by Type
Time frame: Day 7, Day 30, Day 60, Day 90
Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.
Percentage of Subjects With Film Deposits by Type
Time frame: Day 7, Day 30, Day 60, Day 90
Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.
Average Residual Lens Lysozyme
Time frame: Day 30/Early Exit
Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 μg or 0 μg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis.
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Time frame: Baseline (Day 0), Day 7, Day 30, Day 60, Day 90
Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis.
Average Lens Wear Time
Time frame: Day 7, Day 30, Day 60, Day 90
Subject recorded a response to the question, "Averaging over the last 3 days, how many hours per day did you wear your contact lenses?" Lens wear time was measured in hours.
Number of Unscheduled Lens Replacements by Reason
Time frame: Up to Day 90
A fresh pair of lenses was dispensed on Day 0, Day 30, and Day 60. Lenses replaced at other times were considered unscheduled. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject.
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Time frame: Day 7, Day 30, Day 60, Day 90
Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Time frame: Day 7, Day 30, Day 60, Day 90
Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Time frame: Day 7, Day 30, Day 60, Day 90
Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.
Crystalline Deposit Area Covered
Time frame: Day 7, Day 30, Day 60, Day 90
Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.
Film Deposit Area Covered
Time frame: Day 7, Day 30, Day 60, Day 90
Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.

Results and safety

Results posted to the registry on 9 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FID 120947A	239	229
Renu Fresh	113	109

Primary outcome: Percentage of Subjects With Visibly Clean Lenses

Time frame: Day 7, Day 30, Day 60, Day 90. Number. Unit: percentage of subjects

Measure	FID 120947A n = 239	Renu Fresh n = 113
Day 7, n=236, 113	44.5	39.8
Day 30, n=234, 112	35.0	31.3
Day 60, n=232, 110	40.5	32.7
Day 90, n=229, 109	41.9	33.0

Population analysed: This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with data in each treatment group, respectively, by visit.

Primary outcome: Percentage of Subjects With Crystalline Deposits by Type

Time frame: Day 7, Day 30, Day 60, Day 90. Number. Unit: percentage of subjects

Measure	FID 120947A n = 239	Renu Fresh n = 113
Day 7, Type II, n=55,32	63.6	65.6
Day 7, Type III, n=55,32	25.5	25.0
Day 7, Type IV, n=55,32	10.9	9.4
Day 30, Type II, n=74, 37	70.3	59.5
Day 30, Type III, n=74, 37	10.8	16.2
Day 30, Type IV, n=74, 37	18.9	24.3
Day 60, Type II, n=73, 36	63.0	41.7
Day 60, Type III, n=73, 36	13.7	25.0

Population analysed: This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit.

Primary outcome: Percentage of Subjects With Film Deposits by Type

Time frame: Day 7, Day 30, Day 60, Day 90. Number. Unit: percentage of subjects

Measure	FID 120947A n = 239	Renu Fresh n = 113
Day 7, Type II, n=114, 56	57.0	58.9
Day 7, Type III, n=114, 56	16.7	19.6
Day 7, Type IV, n=114, 56	26.3	21.4
Day 30, Type II, n=125, 66	62.4	62.1
Day 30, Type III, n=125, 66	14.4	13.6
Day 30, Type IV, n=125, 66	23.2	24.2
Day 60, Type II, n=114, 63	63.2	55.6
Day 60, Type III, n=114, 63	8.8	7.9

Population analysed: This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with film deposits in each treatment group, respectively, by visit.

Primary outcome: Average Residual Lens Lysozyme

Time frame: Day 30/Early Exit. Mean (Standard Deviation). Unit: micrograms per lens

Measure	FID 120947A n = 233	Renu Fresh n = 112
Value	70.2 (192.1)	114.5 (295.5)

Population analysed: This analysis population includes all subjects with data at visit.

Adverse events

Time frame: An Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, whether or not related to the investigational medical device. AEs are reported as pre-treatment and treatment-emergent.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-treatment	0 of 362 (0%)	0 of 362 (0%)	Not reported
FID 120947A	1 of 238 (0.4%)	0 of 238 (0%)	Not reported
Renu Fresh	0 of 113 (0%)	0 of 113 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Monica Studzinski, Lead CSM study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing FID 120947A contact lens disinfecting solution, renu fresh multi-purpose solution and Soft contact lenses in people with Myopia and Astigmatism, run by Alcon Research.

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 4 inclusion and 11 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 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

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 9 Jun 2015). 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?

Percentage of Subjects With Visibly Clean Lenses (time frame: Day 7, Day 30, Day 60, Day 90). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01912768.

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 9 Jul 2015.