Corneal InfiltratesLASHNCT00727402

Longitudinal Evaluation of Silicone Hydrogel (LASH) Study

An observational study of Corneal Infiltrates, run by National Eye Institute (NEI) 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: Corneal Infiltrates
How many people: 205 participants
Where: 1 siteUnited States
Study dates: Oct 2006to Oct 2009
Phase: Observational
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

Study population: study volunteers from academic community willing to wear extended wear contact lenses

Who may be able to join

The patient must be at least 15 years old. Children younger than this may not be mature enough for CW, and may have difficulty following the strict instructions required for CW or sitting through the exam procedures.
The patient must have clear central corneas and 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 parameters of the Ciba Vision Night and Day Lenses range from +6.00 to -10.00 D, and can correct the refractive range of this population. Monovision correction will be allowed only if the near eye does not exceed +6.00 D.
The patient must be correctable to 20/25 or better with spectacles. Amblyopia will be excluded.
Flat and steep corneal curvatures from SimK readings must be between 39.00 and 48.00 D. Corneal curvatures outside this range may be indicative of a disease state, and patients are not expected to comfortably wear either the 8.4 mm or 8.6 mm base curve available in Night and Day.(Dumbleton K 2002)
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 PMMA lenses within the last 3 months. These lenses can transiently alter the corneal shape and influence the fitting of soft lenses.
The patient must not be a current extended wear user of lotrafilcon A lenses.
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.
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.
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 CW.
The patient is pregnant.

Trial locations and contacts

1 site in 1 country.

United States1 site

University Hospitals Case Medical Center
Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: The Longitudinal Evaluation of Silicone Hydrogel (LASH) Contact Lens Study

The LASH Contact Lens Study is a prospective longitudinal study of silicone hydrogel (SH) contact lens wearers who sleep in their lenses for up to 29 consecutive nights (30 days) of continuous wear (CW), with monthly disposal. Up to 207 healthy nearsighted or farsighted patients with minimal or no astigmatism and no contraindications to CW lens use will be followed for 1 year. The primary outcome measure is the time to development of a corneal inflammatory event (CIE) as defined by slit lamp findings and patient symptoms. The main exposure of interest is corneal staining. Other key exploratory variables include bacterial contamination of study lenses and inflammatory mediators found in the tear film.

Conditions: Corneal Infiltrates

What participants receive

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

Study groups in NCT00727402
Study group	Role	What they receive
Observational		healthy patients fit into lotrafilcon A contact lenses for continuous wear

What is being measured

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

Cumulative Incidence of Corneal Inflammatory Events
Unadjusted cumulative incidence of corneal inflammatory events (CIE)using survival analysis methods. CIE are corneal infiltrates found in an otherwise clear cornea.
Measured: annual

Timeline

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

Oct 2006Oct 2009

First posted4 Aug 2008 (estimated)
Study startOct 2006
Primary completionJan 2009
Study completionOct 2009

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 (4)Papers the sponsor has linked to this study.
Other trials for Corneal InfiltratesStudies 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: Cohort
Time perspective: Prospective
Enrolment: 205 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00727402
Sponsor's protocol ID: K23EY015270-01
Acronym: LASH
Status last verified: Feb 2012
First submitted: 31 Jul 2008
Last updated: 15 Feb 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Szczotka-Flynn L, Lass JH, Sethi A, Debanne S, Benetz BA, Albright M, Gillespie B, Kuo J, Jacobs MR, Rimm A. Risk factors for corneal infiltrative events during continuous wear of silicone hydrogel contact lenses. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5421-30. doi: 10.1167/iovs.10-5456. Epub 2010 Jun 10.
PubMed 20538985
Szczotka-Flynn LB, Bajaksouzian S, Jacobs MR, Rimm A. Risk factors for contact lens bacterial contamination during continuous wear. Optom Vis Sci. 2009 Nov;86(11):1216-26. doi: 10.1097/OPX.0b013e3181bbca18.
PubMed 19786927
Szczotka-Flynn L, Benetz BA, Lass J, Albright M, Gillespie B, Kuo J, Fonn D, Sethi A, Rimm A. The association between mucin balls and corneal infiltrative events during extended contact lens wear. Cornea. 2011 May;30(5):535-42. doi: 10.1097/ICO.0b013e3181fb8644.
PubMed 21173699
Tagliaferri A, Love TE, Szczotka-Flynn LB. Risk factors for contact lens-induced papillary conjunctivitis associated with silicone hydrogel contact lens wear. Eye Contact Lens. 2014 May;40(3):117-22. doi: 10.1097/ICL.0000000000000019.
PubMed 24681609

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Longitudinal Evaluation of Silicone Hydrogel (LASH) Contact Lens Study
ClinicalTrials.gov ID: NCT00727402
Acronym / sponsor ID: LASH / K23EY015270-01
Conditions: Corneal Infiltrates
Study type: Observational
Recruitment status: Completed
Enrolment: 205 participants (actual)
Lead sponsor: National Eye Institute (NEI)US National Institutes of Health
Study start: Oct 2006
Primary completion: Jan 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 4 Aug 2008 (estimated)
Results: Posted 10 Feb 2011

Clinical summary

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Observational	–	–healthy patients fit into lotrafilcon A contact lenses for continuous wear

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: study volunteers from academic community willing to wear extended wear contact lenses

Key inclusion criteria (6 listed)

The patient must be at least 15 years old. Children younger than this may not be mature enough for CW, and may have difficulty following the strict instructions required for CW or sitting through the exam procedures.
The patient must have clear central corneas and 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 parameters of the Ciba Vision Night and Day Lenses range from +6.00 to -10.00 D, and can correct the refractive range of this population. Monovision correction will be allowed only if the near eye does not exceed +6.00 D.
The patient must be correctable to 20/25 or better with spectacles. Amblyopia will be excluded.
Flat and steep corneal curvatures from SimK readings must be between 39.00 and 48.00 D. Corneal curvatures outside this range may be indicative of a disease state, and patients are not expected to comfortably wear either the 8.4 mm or 8.6 mm base curve available in Night and Day.(Dumbleton K 2002)

Key exclusion criteria (8 listed)

The patient has worn rigid gas permeable lenses within the last 30 days or PMMA lenses within the last 3 months. These lenses can transiently alter the corneal shape and influence the fitting of soft lenses.
The patient must not be a current extended wear user of lotrafilcon A lenses.
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.
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.

Primary outcome

Cumulative Incidence of Corneal Inflammatory Events
Time frame: annual
Unadjusted cumulative incidence of corneal inflammatory events (CIE)using survival analysis methods. CIE are corneal infiltrates found in an otherwise clear cornea.

Results and safety

Results posted to the registry on 10 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Observational	205	89

Primary outcome: Cumulative Incidence of Corneal Inflammatory Events

Time frame: annual. Mean (95% Confidence Interval). Unit: annual incidence per 100 subjects

Measure	Observational n = 205
Value	26.7 (20.1 to 35.0)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Observational	0 of 205 (0%)	58 of 205 (28.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20538985Szczotka-Flynn L, Lass JH, Sethi A, Debanne S, Benetz BA, Albright M, Gillespie B, Kuo J, Jacobs MR, Rimm A. Risk factors for corneal infiltrative events during continuous wear of silicone hydrogel contact lenses. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5421-30. doi: 10.1167/iovs.10-5456. Epub 2010 Jun 10.
Results publication: PubMed 19786927Szczotka-Flynn LB, Bajaksouzian S, Jacobs MR, Rimm A. Risk factors for contact lens bacterial contamination during continuous wear. Optom Vis Sci. 2009 Nov;86(11):1216-26. doi: 10.1097/OPX.0b013e3181bbca18.
Results publication: PubMed 21173699Szczotka-Flynn L, Benetz BA, Lass J, Albright M, Gillespie B, Kuo J, Fonn D, Sethi A, Rimm A. The association between mucin balls and corneal infiltrative events during extended contact lens wear. Cornea. 2011 May;30(5):535-42. doi: 10.1097/ICO.0b013e3181fb8644.
Derived from this study: PubMed 24681609Tagliaferri A, Love TE, Szczotka-Flynn LB. Risk factors for contact lens-induced papillary conjunctivitis associated with silicone hydrogel contact lens wear. Eye Contact Lens. 2014 May;40(3):117-22. doi: 10.1097/ICL.0000000000000019.

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 B Szczotka-Flynn, OD, MS principal investigator

Case Western Reserve University

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 Corneal Infiltrates, run by National Eye Institute (NEI) at 1 site 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 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 15 Feb 2012. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2011). 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?

Cumulative Incidence of Corneal Inflammatory Events (time frame: annual). 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 NCT00727402, which also lists 4 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 15 Feb 2012.