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Corneal InflammationPhase 1/2NCT01437319

Mucin Balls and Corneal Inflammation Events

A Phase 1/2 study testing lotrafilcon A, comfilcon A and balafilcon A in people with Corneal Inflammation and Corneal Infiltrative Events, run by Johnson & Johnson Vision Care, Inc. at 3 sites 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

The purpose of this study is to determine if the formation of mucin balls is a marker for protection from inflammatory events to the cornea and if mucin balls play a role in protection during extended contact lens wear. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
lotrafilcon A, comfilcon A and balafilcon A
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
289 participants
Where
3 sitesUnited States
Study dates
Sep 2011to Feb 2014
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 18 years
  • Free of any active anterior segment disorders that would preclude safe contact lens wear. Active anterior segment disorders and evidence of central microbial keratitis (via a large, >1mm central deep stromal scar) are not allowed. However, evidence of past Contact Lens-Induces Peripheral Ulcer (CLPU) will be allowed so long as no more then three such scars are detected bilaterally. Evidence of more than 3 CLPU-like scars places excessive risk on the subject for a subsequent Corneal Infiltrate Event (CIE).
  • Correctable vision to 20/25 or better in each eye with spectacles. Amblyopia will be excluded.
  • Flat and steep corneal curvatures from keratometry readings must be between 39.00 and 48.50 D, respectively.
  • Own or agree to purchase a pair of spectacles that can be worn when lenses are removed or in cases of ocular discomfort or emergency.
  • Correctable vision to 20/30 or better at distance with dispensed contact lenses.

Who cannot join

  • Use/wear of rigid gas permeable lenses within the last 30 days or Poly (methyl methacrylate) (PMMA) lenses within the last 3 months.
  • Immunocompromising disease or insulin dependent diabetes or any other systemic disease that in the investigator's opinion will affect ocular health or increase risk during extended wear.
  • Chronic use of systemic corticosteroids (with the exception of corticosteroid inhalers) or any other medication that in the investigator's opinion will affect ocular physiology or study participation.
  • Ocular disease or condition such as aphakia, corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery.
  • Use of any ocular medications in the last 2 weeks.
  • 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.
Show all 9Show fewer
  • Currently pregnant or lactating.
  • Smoker
  • Swimming routine of more than twice per month.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Study site

    Beachwood, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Columbus, Ohio

Other trials in United States

About this study

The purpose of this study is to determine if the formation of mucin balls is a marker for protection from inflammatory events to the cornea and if mucin balls play a role in protection during extended contact lens wear.

Being tested
lotrafilcon A, comfilcon A, balafilcon A, etafilcon A
Medical subject headings
Keratitis

What participants receive

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

  • lotrafilcon ADevice

    To be used during run-in phase only.

  • comfilcon ADevice

    To be assigned at randomization at phase 2 only.

  • balafilcon ADevice

    To be assigned at randomization during phase 2 only.

  • etafilcon AOther

    Assigned to Neophytes during Phase I for a 2-week period

Study groups in NCT01437319
Study groupRoleWhat they receive
lotrafilcon A, comfilcon AActive comparatorAll subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to comfilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I.
Receives: Device: lotrafilcon A; Device: comfilcon A; Other: etafilcon A
lotrafilcon A, balafilcon AActive comparatorAll subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to balafilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I.
Receives: Device: lotrafilcon A; Device: balafilcon A; Other: etafilcon A

What is being measured

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

  1. Corneal Infiltrate Events - Phase I

    The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.

    Measured: 1-Month Follow-up

  2. Corneal Infiltrate Event- Phase II

    The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.

    Measured: 12-Month Follow-up

Timeline

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

  1. First posted20 Sep 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

Resources

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 1/2
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
289 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01437319
Sponsor's protocol ID
CR-005016
Status last verified
Jan 2016
First submitted
16 Sep 2011
Last updated
19 Jun 2018

Publications

  • Szczotka-Flynn LB, Jiang Y, Stiegemeier MJ, Mutti DO, Walline J, Wilson T, Debanne S; Mucin Ball Study Group. Mucin Balls Influence Corneal Infiltrative Events. Optom Vis Sci. 2017 Apr;94(4):448-457. doi: 10.1097/OPX.0000000000001045.

    PubMed 28195933

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing lotrafilcon A, comfilcon A and balafilcon A in people with Corneal Inflammation and Corneal Infiltrative Events, run by Johnson & Johnson Vision Care, Inc. at 3 sites in United States.

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 9 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 3 sites 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 25 Feb 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?

Corneal Infiltrate Events - Phase I (time frame: 1-Month Follow-up). 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?

On the ClinicalTrials.gov record for NCT01437319, which also lists 1 linked publication.

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.

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