Corneal Inflammation, Corneal Infiltrative Events
Conditions
Brief 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.
Interventions
DEVICElotrafilcon A
To be used during run-in phase only.
DEVICEcomfilcon A
To be assigned at randomization at phase 2 only.
DEVICEbalafilcon A
To be assigned at randomization during phase 2 only.
OTHERetafilcon A
Assigned to Neophytes during Phase I for a 2-week period
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Currently pregnant or lactating. * Smoker * Swimming routine of more than twice per month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Infiltrate Events - Phase I | 1-Month Follow-up | The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification. |
| Corneal Infiltrate Event- Phase II | 12-Month Follow-up | The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification. |
Countries
United States
Participant flow
Recruitment details
289 Subjects were enrolled in the study. 7 subjects did not meet the eligibility criteria. 282 subjects entered Phase I. During Phase I, 55 subjects were either lost to follow-up or discontinued. The remaining 227 subjects were randomized to either comfilcon A or balafilcon A and entered Phase II. 146 subjects completed Phase II
Pre-assignment details
During Phase I, subjects are classified as either repeated Mucin Ball former or Non-Repeat Mucin Ball former. The 227 subjects that entered Phase II kept there Mucin ball classification, but were still randomized to either comfilcon A or balafilcon A. All comparisons are made between Mucin Ball classification
Participants by arm
| Arm | Count |
|---|---|
| Overall The analysis population consists of all subjects that were enrolled into the study. | 282 |
| Total | 282 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Phase I | Lost to Follow-up | 2 | 0 | 0 |
| Phase I | Protocol Violation | 1 | 0 | 0 |
| Phase I | Study related symptoms/complaints | 27 | 0 | 0 |
| Phase I | Withdrawal by Subject | 25 | 0 | 0 |
| Phase II | Lost to Follow-up | 0 | 7 | 2 |
| Phase II | Protocol Violation | 0 | 1 | 0 |
| Phase II | Study related symptoms/complaints | 0 | 28 | 19 |
| Phase II | Withdrawal by Subject | 0 | 8 | 16 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 33.8 years STANDARD_DEVIATION 11.6 |
| Region of Enrollment United States | 282 participants |
| Sex: Female, Male Female | 182 Participants |
| Sex: Female, Male Male | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 30 / 115 | 24 / 112 | 23 / 282 |
| serious Total, serious adverse events | 0 / 115 | 0 / 112 | 0 / 282 |
Outcome results
Primary
Corneal Infiltrate Event- Phase II
The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.
Time frame: 12-Month Follow-up
Population: The analysis population consists of subjects that were enrolled into Phase II and were correctly classified as either repeat Mucin Ball former or Non-repeat Mucin Ball former. Twenty- three subjects had incorrect Mucin ball classification.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Repeat Mucin Ball Former | Corneal Infiltrate Event- Phase II | balafilcon A, N=66, N=28 | 4.5 percentage of subjects |
| Repeat Mucin Ball Former | Corneal Infiltrate Event- Phase II | comfilcon A, N=87, N=15 | 14.9 percentage of subjects |
| Non-repeat Mucin Ball Former | Corneal Infiltrate Event- Phase II | balafilcon A, N=66, N=28 | 3.6 percentage of subjects |
| Non-repeat Mucin Ball Former | Corneal Infiltrate Event- Phase II | comfilcon A, N=87, N=15 | 33.3 percentage of subjects |
Primary
Corneal Infiltrate Events - Phase I
The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.
Time frame: 1-Month Follow-up
Population: The analysis population consists of subjects that completed all study visits in Phase I without a major protocol deviation and were correctly classified as either repeat Mucin Ball former or Non-repeat Mucin Ball former. Five subjects had incorrect Mucin Ball classification and 8 subjects met study objective.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Repeat Mucin Ball Former | Corneal Infiltrate Events - Phase I | 18.6 percentage of subjects |
| Non-repeat Mucin Ball Former | Corneal Infiltrate Events - Phase I | 5.7 percentage of subjects |