Corneal Swelling
Conditions
Brief summary
This is a prospective, single site, unmasked, cross-over study with three silicone hydrogel contact lenses comparing central corneal swelling.
Interventions
DEVICEetafilcon A
spherical hydrophilic soft contact lens worn in a daily wear modality
DEVICElotrafilcon B
DEVICEcomfilcon A
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. The participant must be at leat 18 years old or older and no greater than 65 years old. Children younger than18 will likely no be able to come back and forth to the clinic during the typical work week as outlined in the above (due to school schedules) and thus not be able to adhere to the protocol. 2. The participant must be a current soft contact lens wearer who routinely wears lenses at least 6-8 hours per day and at least 4 days per week for at least the past 3 months. 3. Refraction suitable for spherical soft contact lens powers between -1.00 and -6.00 D the participant must be correctable to 20/30 or better at distance with both eyes with dispensed contact lenses. 4. The participant must be free of any active anterior segment disorders that would preclude safe contact lens wear. Active anterior segment disorders and evidence of central microbial keratitis are not allowed. However, evidence of past CLPU will be allowed so long as no more than 3 such scars are detected bilaterally. Evidence of more than 3 CLPU-like scars places excessive risk on the participant for subsequent CIE. 5. The participant must be correctable to 20/25 or better in each eye with spectacles. Amblyopia will be excluded. 6. Flat and steep corneal curvatures from keratometry readings must be between 39.00 and 48.50 D, respectively. Corneal curvatures outside this range may be indicative of a disease state, and the participants are not expected to comfortably wear the study lenses. 7. The participant must own or agree to purchase a pair of spectacles that can be worn when lenses are removed, during the washout periods, or in case of ocular discomfort or emergency.
Exclusion criteria
1. The participant has worn rigid gas permeable contact lenses within the last 30 days or PMMA lenses within the past 12 months. These lenses can transiently alter the corneal shape and influence the fitting of soft contact lenses or alter endothelial cell morphology. 2. The participant has an immunocompromising disease or any other systemic disease that in the investigator's opinion will affect ocular health or increase risk during daily contact lens wear. 3. The participant is taking any medication that in the investigator's opinion will affect ocular physiology or study participation. 4. The participant has an ocular disease or condition such as aphakia, clinically significant corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery. 5. The participant is taking any ocular medications. If a participant was previous taking any ocular medications, the medications must have been discontinued at least 2 weeks prior to enrollment. 6. The participant 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. 7. The participant is currently pregnant or lactating. Participant who become pregnant during the study will be discontinued. 8. An employee or member of the UHCMC Eye Institute or a family member of any study personnel.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central Corneal Swelling | 6-8 Hours Post lens insertion | Corneal swelling measurements were taken in the right eye during slit lamp evaluations, 6-8 hours post lens insertion. The average corneal swelling per lens was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Limbal Redness | 6-8 hours post lens insertion | Limbal redness was assessed in both eyes using a slit lamp, 6-8 hours post lens insertion. Redness was assessed in 4 regions of the eye (nasal, temporal, inferior and superior) and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). For each region (nasal, temporal, inferior and superior) the average grade was calculated by lens. The Total Grade was then calculated by summing all the average grade for each region. The regional average grade ranges from 0 to 4. The total Grade ranges from 0 to 16. |
Countries
United States
Participant flow
Pre-assignment details
A total of 41 subjects were enrolled in this study. Of the enrolled subjects 3 did not meet the eligibility criteria and 38 subjects were dispensed a study lens. Of the dispensed subjects 2 were discontinued while 36 completed all study visits.
Participants by arm
| Arm | Count |
|---|---|
| Overall All subjects that were dispensed at least one study lens. | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Period 1 | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 0 |
| Period 2 | Adverse Event | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 32.9 years STANDARD_DEVIATION 8.71 |
| Race/Ethnicity, Customized Asian | 9 participants |
| Race/Ethnicity, Customized Black or African American | 10 participants |
| Race/Ethnicity, Customized White | 19 participants |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 5 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 | 0 / 37 | 0 / 38 | 0 / 36 |
| serious Total, serious adverse events | 0 / 37 | 0 / 38 | 0 / 36 |
Outcome results
Primary
Central Corneal Swelling
Corneal swelling measurements were taken in the right eye during slit lamp evaluations, 6-8 hours post lens insertion. The average corneal swelling per lens was reported.
Time frame: 6-8 Hours Post lens insertion
Population: All subjects that were dispensed at least one study lens throughout the duration of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A | Central Corneal Swelling | 542.2 um | Standard Deviation 31.28 |
| Lotrafilcon B | Central Corneal Swelling | 542.4 um | Standard Deviation 30.69 |
| Comfilcon A | Central Corneal Swelling | 544.3 um | Standard Deviation 28.3 |
Secondary
Limbal Redness
Limbal redness was assessed in both eyes using a slit lamp, 6-8 hours post lens insertion. Redness was assessed in 4 regions of the eye (nasal, temporal, inferior and superior) and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). For each region (nasal, temporal, inferior and superior) the average grade was calculated by lens. The Total Grade was then calculated by summing all the average grade for each region. The regional average grade ranges from 0 to 4. The total Grade ranges from 0 to 16.
Time frame: 6-8 hours post lens insertion
Population: All subjects that were dispensed at least one study lens throughout the duration of this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A | Limbal Redness | 6.46 units on a scale | Standard Deviation 1.233 |
| Lotrafilcon B | Limbal Redness | 6.24 units on a scale | Standard Deviation 1.177 |
| Comfilcon A | Limbal Redness | 6.14 units on a scale | Standard Deviation 0.977 |