MyopiaPhase 4DWCIENCT00937105

Daily Wear Corneal Infiltrative Event Study

A Phase 4 study testing lotrafilcon A contact lenses, Renu Multiplus and Clear Care in people with Myopia and Hyperopia, run by University Hospitals Cleveland Medical Center at 1 site in United States.

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

Who is it for?: Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for: Myopia, Hyperopia, Corneal Infiltrative Events
What is being tested?: lotrafilcon A contact lenses, Renu Multiplus and Clear Care
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 218 participants
Where: 1 siteUnited States
Study dates: Nov 2009to Feb 2012
Phase: Phase 4
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 15 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

The patient must be at least 15 years old.
The patient must be free of any anterior segment disorders.
The patient must have a spectacle corrected spherical refractive error between +5.50 D and -11.00 D with less than or equal to 1.00 D refractive cylinder.
The patient must be correctable to 20/25 or better with spectacles.
Flat and steep corneal curvatures from Simulated Keratometry readings must be between 39.00 and 48.00 D.
Can be successfully fit with lotrafilcon A lenses at the enrollment visit.

Who cannot join

The patient has worn rigid gas permeable lenses within the last 30 days or polymethylmethacrylate lenses within the last 3 months.
The patient must not be a current successful daily wear user of lotrafilcon A lenses. They may have tried lotrafilcon A lenses in the past, but must not have successfully worn these lenses for daily wear within the last 12 months.
The patient has an autoimmune disease (except for Hashimoto's Thyroiditis), immunocompromising disease, connective tissue disease, atopic dermatitis, insulin dependent diabetes, or any other systemic disease that in the investigator's opinion will affect ocular health.
The patient is taking chronic systemic medications such as corticosteroids, antimetabolites, or non-steroidal anti-inflammatory agents or any other medication that in the investigator's opinion will affect ocular physiology or study participation.
The patient has any ocular disease or condition such as aphakia, corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery.
The patient is taking any ocular medications. If a patient was previously taking any ocular medications, the medications must have been discontinued at least 2 weeks prior to enrollment.
The patient must have less than or equal to grade 2 on any of the slit lamp observations of: upper tarsal papilla, corneal staining, corneal neovascularization, conjunctival injection, and lid erythema or scales. Slit lamp findings higher than grade 2 bias the patient toward an adverse event and it may be difficult to detect true change related to contact lens use.
The patient is pregnant.

Trial locations and contacts

1 site in 1 country.

United States1 site

Department of Ophthalmology University Hospitals Case Medical Center
Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: Infiltrative Events During Silicone Hydrogel Daily Contact Lens (Daily Wear Corneal Infiltrative Event (DWCIE) Study)

This DWCIE Study is a prospective cohort study of patients fit to the FDA approved and marketed lotrafilcon A (Ciba Vision, Air Optix Night \& Day Aqua) soft contact lenses for daily wear (DW) with monthly disposal. 218 healthy myopic (nearsighted) or hyperopic (farsighted) patients with minimal or no astigmatism and no contraindications to DW lens use will be followed for 1 year. The primary outcome is the risk of development of a corneal inflammatory event (CIE) as defined by slit lamp findings and patient symptoms. The main exposure of interest is microbial contamination of study lenses.

Conditions: Myopia, Hyperopia, Corneal Infiltrative Events
Being tested: lotrafilcon A contact lenses, Renu Multiplus, Clear Care
Medical subject headings: Myopia, Hyperopia

What participants receive

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

lotrafilcon A contact lensesDevice
Also called Air Optix Night & Day Aqua contact lenses
FDA approved soft contact lenses
Renu MultiplusDevice
Clear CareDevice

Study groups in NCT00937105
Study group	Role	What they receive
ReNu Multiplus and lotrafilcon A lenses	Active comparator	ReNu Multiplus contact lens care solution Receives: Device: lotrafilcon A contact lenses; Device: Renu Multiplus
Clear Care solution and lotrafilcon A lenses	Active comparator	Clear Care Contact Lens Care Solution Receives: Device: lotrafilcon A contact lenses; Device: Clear Care

What is being measured

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

Number of Participants Developing a Corneal Inflammatory Event (CIE)
Raw number of participants in each solution arm developing CIE over 12 month follow-up period
Measured: up to 1 year

Secondary outcomes (5)

Number of Participants With CIE Stratified by Microbial Bioburden on Lenses
Microbial bioburden on lenses was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lenses
Measured: up to 1 year
Number of Participants With CIE Based Stratified by Presence or Absence of Corneal Staining Induced by Solution Use.
Presumed solution induced corneal staining was defined as diffuse punctate fluorescein staining of at least 15% surface area in at least 4 of 5 zones
Measured: up to 1 year
Number of Participants With CIE Stratified by Microbial Bioburden on Lens Cases
Microbial bioburden within lens storage cases was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora
Measured: up to 1 year
Number of Participants With CIE Stratified by Overall Microbial Bioburden on Lid Margins
Microbial bioburden on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lids
Measured: up to 1 year
Number of Participants With CIE Stratified by CNS Microbial Bioburden on Lid Margins
Microbial bioburden with coagulase negative staphylococci (CNS) on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal CNS flora on lids
Measured: up to 1 year

Timeline

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

Nov 2009Feb 2012

First posted10 Jul 2009 (estimated)
Study startNov 2009
Primary completionFeb 2012
Study completionFeb 2012

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for MyopiaStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 218 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00937105
Sponsor's protocol ID: 001
Acronym: DWCIE
Status last verified: Jan 2014
First submitted: 9 Jul 2009
Last updated: 10 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Szczotka-Flynn L, Jiang Y, Raghupathy S, Bielefeld RA, Garvey MT, Jacobs MR, Kern J, Debanne SM. Corneal inflammatory events with daily silicone hydrogel lens wear. Optom Vis Sci. 2014 Jan;91(1):3-12. doi: 10.1097/OPX.0000000000000105.
PubMed 24240354
Jiang Y, Jacobs M, Bajaksouzian S, Foster AN, Debanne SM, Bielefeld R, Garvey M, Raghupathy S, Kern J, Szczotka-Flynn LB. Risk factors for microbial bioburden during daily wear of silicone hydrogel contact lenses. Eye Contact Lens. 2014 May;40(3):148-56. doi: 10.1097/ICL.0000000000000026.
PubMed 24756119

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?

See locations

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Infiltrative Events During Silicone Hydrogel Daily Contact Lens (Daily Wear Corneal Infiltrative Event (DWCIE) Study)
ClinicalTrials.gov ID: NCT00937105
Acronym / sponsor ID: DWCIE / 001
Conditions: Myopia, Hyperopia, Corneal Infiltrative Events
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 218 participants (actual)
Lead sponsor: University Hospitals Cleveland Medical CenterUniversity, hospital or other
Collaborators: Alcon Research
Study start: Nov 2009
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 10 Jul 2009 (estimated)
Results: Posted 10 Mar 2014

Clinical summary

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

Study design

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

Arm	Type	Receives
ReNu Multiplus and lotrafilcon A lenses	Active comparator	Device: lotrafilcon A contact lenses, Device: Renu MultiplusReNu Multiplus contact lens care solution
Clear Care solution and lotrafilcon A lenses	Active comparator	Device: lotrafilcon A contact lenses, Device: Clear CareClear Care Contact Lens Care Solution

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

The patient must be at least 15 years old.
The patient must be free of any anterior segment disorders.
The patient must have a spectacle corrected spherical refractive error between +5.50 D and -11.00 D with less than or equal to 1.00 D refractive cylinder.
The patient must be correctable to 20/25 or better with spectacles.
Flat and steep corneal curvatures from Simulated Keratometry readings must be between 39.00 and 48.00 D.

Key exclusion criteria (8 listed)

The patient has worn rigid gas permeable lenses within the last 30 days or polymethylmethacrylate lenses within the last 3 months.
The patient must not be a current successful daily wear user of lotrafilcon A lenses. They may have tried lotrafilcon A lenses in the past, but must not have successfully worn these lenses for daily wear within the last 12 months.
The patient has an autoimmune disease (except for Hashimoto's Thyroiditis), immunocompromising disease, connective tissue disease, atopic dermatitis, insulin dependent diabetes, or any other systemic disease that in the investigator's opinion will affect ocular health.
The patient is taking chronic systemic medications such as corticosteroids, antimetabolites, or non-steroidal anti-inflammatory agents or any other medication that in the investigator's opinion will affect ocular physiology or study participation.
The patient has any ocular disease or condition such as aphakia, corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery.

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
lotrafilcon A contact lensesAlso: Air Optix Night & Day Aqua contact lensesFDA approved soft contact lenses	Device	Clear Care solution and lotrafilcon A lenses, ReNu Multiplus and lotrafilcon A lenses
Renu Multiplus	Device	ReNu Multiplus and lotrafilcon A lenses
Clear Care	Device	Clear Care solution and lotrafilcon A lenses

Primary outcome

Number of Participants Developing a Corneal Inflammatory Event (CIE)
Time frame: up to 1 year
Raw number of participants in each solution arm developing CIE over 12 month follow-up period

5 secondary outcomes

Number of Participants With CIE Stratified by Microbial Bioburden on Lenses
Time frame: up to 1 year
Number of Participants With CIE Based Stratified by Presence or Absence of Corneal Staining Induced by Solution Use.
Time frame: up to 1 year
Number of Participants With CIE Stratified by Microbial Bioburden on Lens Cases
Time frame: up to 1 year
Number of Participants With CIE Stratified by Overall Microbial Bioburden on Lid Margins
Time frame: up to 1 year
Number of Participants With CIE Stratified by CNS Microbial Bioburden on Lid Margins
Time frame: up to 1 year

Results and safety

Results posted to the registry on 10 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lotrafilcon A Lenses and Clear Care	109	69
Lotrafilcon A Lenses and Renu Multiplus	109	70

Primary outcome: Number of Participants Developing a Corneal Inflammatory Event (CIE)

Time frame: up to 1 year. Number. Unit: participants

Measure	Lotrafilcon A Lenses and Renu n = 109	Lotrafilcon A Lenses and Clear Care n = 109
Value	6 (88.1 to 96.5)	7

Lotrafilcon A Lenses and Renu vs Lotrafilcon A Lenses and Clear Care: Cumulative Probability of no-CIE: 92.8 (95% CI 88.6 to 96.9), Kaplan-Meier

Population analysed: This primary analysis includes the cohort of all 218 randomized participants. The measured values stratify participants by solution group, however, the statistical analysis reports on the entire cohort (both solution groups) consistent with the primary aim of the study.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Entire Cohort of Lotrafilcon A Users	1 of 218 (0.5%)	23 of 218 (10.6%)	Not reported

Limitations and caveats (from the sponsor): Mostly asymptomatic CIE events occurred which limited the ability to retrieve the lens worn (for culture) precisely at the time of CIE development; this may have hindered our ability to capture bioburden at the time of the adverse event.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24240354Szczotka-Flynn L, Jiang Y, Raghupathy S, Bielefeld RA, Garvey MT, Jacobs MR, Kern J, Debanne SM. Corneal inflammatory events with daily silicone hydrogel lens wear. Optom Vis Sci. 2014 Jan;91(1):3-12. doi: 10.1097/OPX.0000000000000105.
Derived from this study: PubMed 24756119Jiang Y, Jacobs M, Bajaksouzian S, Foster AN, Debanne SM, Bielefeld R, Garvey M, Raghupathy S, Kern J, Szczotka-Flynn LB. Risk factors for microbial bioburden during daily wear of silicone hydrogel contact lenses. Eye Contact Lens. 2014 May;40(3):148-56. doi: 10.1097/ICL.0000000000000026.

Related trials for Myopia

Not yet recruitingObservational study
Corneal Biomechanics and Stromal Tissue Characteristics in Patients Undergoing SMILE
Myopia
Enrolling by invitation
Therapeutic Efficacy of Different Repeated Low-Intensity Red Light Devices and Different Usage Frequencies
Myopia
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
Recruiting
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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.

Loretta Szczotka-Flynn, OD, PhD principal investigator

University Hospitals Cleveland Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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 10 Mar 2014. 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 States. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2014). 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?

Number of Participants Developing a Corneal Inflammatory Event (CIE) (time frame: up to 1 year). 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 NCT00937105, which also lists 2 linked publications.

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 10 Mar 2014; AzTrials last refreshed its copy on 1 Nov 2026.