Corneal Swelling
Conditions
Brief summary
The primary purpose of this clinical trial is to evaluate the eye's response to three test soft contact lenses as well as no lens wear, with respect to Corneal Staining.
Interventions
DEVICEetafilcon A with Lacreon
contact lens with Lacreon
DEVICEetafilcon A with Lacreon with print
contact lens with Lacreon and cosmetic print
DEVICEetafilcon A with print
contact lens with print
DEVICESpectacles (habitual)
Spectacles
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. 2. The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol. 3. The subject must be between 18 and 45 years of age. 4. The subject must be an adapted soft contact lens wearer in both eyes. 5. The subject must be of East or Southeast Asian descent, e.g. ethnic Chinese, Japanese, Korean, Malay, Vietnamese, Indonesian, Filipino, etc. (it is preferred but not required that both the subject's biological parents are East or Southeast Asian ethnicity, by self report). 6. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 D in each eye. 7. The subject's refractive cylinder must be no more than 1.00D in each eye. 8. The subject must have best corrected visual acuity of +0.14 logMAR (equivalent to 20/25-2) or better in each eye. 9. Subjects must own a wearable pair of spectacles and wear them on the day of the initial visit, during the washout before each phase and during the no lens wear phase. 10. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
Exclusion criteria
1. Are currently pregnant or lactating by self report (subjects who become pregnant during the study will be discontinued). 2. Have any ocular or systemic allergies or diseases that may interfere with contact lens wear. 3. Have any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but may not be limited to, diabetes. hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, Stevens-Johnson syndromes, HIV/AIDS, hepatitis, and tuberculosis. 4. Use of any topical medications such aas eye drops or ointments. 5. Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosion, or aphakia. 6. Had any previous, or planned ocular or intraocular surgery (e.g. cataract surgery, radial keratotomy, PRK, LASIK, etc.). 7. Have any grade 2.0 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Efron classification scale or any other ocular abnormality that may contraindicate contact lens wear. 8. Have any known hypersensitivity or allergic reaction to one of the study products. 9. Have any ocular infection. 10. Have any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 11. Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. 12. Have any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV by self report). 13. Currently wear their contact lenses on an extended wear basis. 14. Are an employee of the investigational clinic (e.g. Investigator, Coordinator, Technician)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline of Corneal Swelling 8 Hours Post Fit | 8 hours post fit | Central corneal thickness was measured at baseline and 8-hour post fit with a modified optical pachometer on a Zeiss biomicroscope, interfaced to a PC. The pachometry measurement included seven readings; the computer is programmed to remove the high and low readings and to calculate the average of the remaining five readings. Only a single central corneal thickness measurement, the average of the 5 readings, was recorded by the investigator in the eCRF. The average percent change from baseline of corneal swelling was reported and was calculated as: ((Post fit - Baseline)/ Baseline) X 100. |
Countries
Canada
Participant flow
Recruitment details
A total of 39 subjects were enrolled in this study. Of those enrolled subjects 15 subjects did not meet the eligibility criteria. The remaining 24 subjects were successfully dispensed a study lens and completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Overall All subjects that were dispensed a study lens. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 21.13 years STANDARD_DEVIATION 2.437 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 24 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Canada | 24 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 |
Outcome results
Primary
Percentage Change From Baseline of Corneal Swelling 8 Hours Post Fit
Central corneal thickness was measured at baseline and 8-hour post fit with a modified optical pachometer on a Zeiss biomicroscope, interfaced to a PC. The pachometry measurement included seven readings; the computer is programmed to remove the high and low readings and to calculate the average of the remaining five readings. Only a single central corneal thickness measurement, the average of the 5 readings, was recorded by the investigator in the eCRF. The average percent change from baseline of corneal swelling was reported and was calculated as: ((Post fit - Baseline)/ Baseline) X 100.
Time frame: 8 hours post fit
Population: Analysis population consists of subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test 1 (Etafilcon A With Lacreon) | Percentage Change From Baseline of Corneal Swelling 8 Hours Post Fit | 0.07 percentage of change from baseline | Standard Deviation 0.288 |
| Test 2 (Etafilcon A With Lacreon With Print) | Percentage Change From Baseline of Corneal Swelling 8 Hours Post Fit | -0.02 percentage of change from baseline | Standard Deviation 0.286 |
| Test 3 (Etafilcon A With Print) | Percentage Change From Baseline of Corneal Swelling 8 Hours Post Fit | 0.14 percentage of change from baseline | Standard Deviation 0.35 |
| Spectacle | Percentage Change From Baseline of Corneal Swelling 8 Hours Post Fit | -0.06 percentage of change from baseline | Standard Deviation 0.293 |