Myopia, Hyperopia, Corneal Infiltrative Events
Conditions
Brief summary
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.
Interventions
Sponsors
Alcon Research
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. The patient must be at least 15 years old. 2. The patient must be free of any anterior segment disorders. 3. 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. 4. The patient must be correctable to 20/25 or better with spectacles. 5. Flat and steep corneal curvatures from Simulated Keratometry readings must be between 39.00 and 48.00 D. 6. Can be successfully fit with lotrafilcon A lenses at the enrollment visit.
Exclusion criteria
1. The patient has worn rigid gas permeable lenses within the last 30 days or polymethylmethacrylate lenses within the last 3 months. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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. 7. 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. 8. The patient is pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Developing a Corneal Inflammatory Event (CIE) | up to 1 year | Raw number of participants in each solution arm developing CIE over 12 month follow-up period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With CIE Stratified by Microbial Bioburden on Lenses | up to 1 year | 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 |
| Number of Participants With CIE Based Stratified by Presence or Absence of Corneal Staining Induced by Solution Use. | up to 1 year | 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 |
| Number of Participants With CIE Stratified by Microbial Bioburden on Lens Cases | up to 1 year | 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 |
| Number of Participants With CIE Stratified by Overall Microbial Bioburden on Lid Margins | up to 1 year | 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 |
| Number of Participants With CIE Stratified by CNS Microbial Bioburden on Lid Margins | up to 1 year | 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 |
Countries
United States
Participant flow
Recruitment details
From November 2009 to February 2012, 218 participants were randomized at the University Hospitals Case Medical Center Eye Institute.
Pre-assignment details
Existing soft lens wearers or non contact lens wearers were recruited, no wash out period was required
Participants by arm
| Arm | Count |
|---|---|
| Lotrafilcon A and Renu | 109 |
| Lotrafilcon A and Clear Care | 109 |
| Total | 218 |
Baseline characteristics
| Characteristic | Lotrafilcon A and Clear Care | Lotrafilcon A and Renu | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 107 Participants | 108 Participants | 215 Participants |
| Age, Continuous | 34.9 years STANDARD_DEVIATION 11.5 | 34.4 years STANDARD_DEVIATION 11.3 | 34.7 years STANDARD_DEVIATION 11.4 |
| Region of Enrollment United States | 109 participants | 109 participants | 218 participants |
| Sex: Female, Male Female | 75 Participants | 78 Participants | 153 Participants |
| Sex: Female, Male Male | 34 Participants | 31 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 218 |
| serious Total, serious adverse events | 1 / 218 |
Outcome results
Primary
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
Time frame: up to 1 year
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lotrafilcon A Lenses and Renu | Number of Participants Developing a Corneal Inflammatory Event (CIE) | 6 participants |
| Lotrafilcon A Lenses and Clear Care | Number of Participants Developing a Corneal Inflammatory Event (CIE) | 7 participants |
Comparison: Cumulative Unadjusted Probability of Remaining Infiltrate Free in entire Cohort95% CI: [88.6, 96.9]Kaplan-Meier
Secondary
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
Time frame: up to 1 year
Population: Number of participants with valid presumed solution induced corneal staining data in each group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lotrafilcon A Lenses and Renu | Number of Participants With CIE Based Stratified by Presence or Absence of Corneal Staining Induced by Solution Use. | 2 participants |
| Lotrafilcon A Lenses and Clear Care | Number of Participants With CIE Based Stratified by Presence or Absence of Corneal Staining Induced by Solution Use. | 8 participants |
p-value: 0.794395% CI: [0.167, 10.393]Regression, Cox
Secondary
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
Time frame: up to 1 year
Population: All participants in which valid lids bioburden data was available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lotrafilcon A Lenses and Renu | Number of Participants With CIE Stratified by CNS Microbial Bioburden on Lid Margins | 8 participants |
| Lotrafilcon A Lenses and Clear Care | Number of Participants With CIE Stratified by CNS Microbial Bioburden on Lid Margins | 2 participants |
p-value: 0.0495% CI: [1.1, 24.7]Regression, Cox
Secondary
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
Time frame: up to 1 year
Population: All participants in which valid lens case bioburden data was available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lotrafilcon A Lenses and Renu | Number of Participants With CIE Stratified by Microbial Bioburden on Lens Cases | 5 participants |
| Lotrafilcon A Lenses and Clear Care | Number of Participants With CIE Stratified by Microbial Bioburden on Lens Cases | 3 participants |
p-value: 0.589495% CI: [0.161, 2.822]Regression, Cox
Secondary
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
Time frame: up to 1 year
Population: All participants in which valid lens bioburden data was available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lotrafilcon A Lenses and Renu | Number of Participants With CIE Stratified by Microbial Bioburden on Lenses | 4 participants |
| Lotrafilcon A Lenses and Clear Care | Number of Participants With CIE Stratified by Microbial Bioburden on Lenses | 6 participants |
Comparison: To determine if microbial contamination of lenses is a risk factor for CIEp-value: 0.392395% CI: [0.49, 6.156]Regression, Cox
Secondary
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
Time frame: up to 1 year
Population: All participants in which valid lens bioburden data was available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lotrafilcon A Lenses and Renu | Number of Participants With CIE Stratified by Overall Microbial Bioburden on Lid Margins | 10 participants |
| Lotrafilcon A Lenses and Clear Care | Number of Participants With CIE Stratified by Overall Microbial Bioburden on Lid Margins | 0 participants |
p-value: 0.174295% CI: [0.678, 8.537]Regression, Cox