Contact Lens Wear
Conditions
Keywords
refractive index
Brief summary
This was a single-site, bilateral, repeated-measures insertion study in habitual soft contact lens wearers. Ten participants were enrolled. All participants attended a Screening/Dispensing Visit at which informed consent was obtained and eligibility was assessed. Eligible participants then wore each of three commercially available daily disposable soft contact lens types - kalifilcon A (Bausch + Lomb), Dailies Total1 (delefilcon A, Alcon) and Precision1 (verofilcon A, Alcon), all -3.00 D - bilaterally for wear times of 0.5, 1, 3, 5 and 10 minutes over a total of 6 study visits. A new lens pair was inserted for each wear time, with a 3-5 minute washout period between lens pairs. Immediately following removal, the right-eye lens was measured for surface refractive index on a Metricon M-2010 Prism Coupler.
Detailed description
Rationale: earlier work (ROC2-20-012) showed a change in surface refractive index for Dailies Total1 (delefilcon A) and Precision1 (verofilcon A) lenses after 5 minutes of wear, attributed to a change in surface water content. ROC2-21-007 was designed to determine whether that change occurs in less than 5 minutes. Three study lenses (one test, two controls) were each worn bilaterally. Wear times of 0.5, 1 and 3 minutes were completed at one visit and 5 and 10 minutes at another visit for each lens type, giving 6 visits of approximately 30 minutes each, each on a separate day; the clinical investigation took approximately 2 weeks. Lens type order followed the study randomization schedule prepared before enrolment by an unmasked statistician not otherwise involved in the study; unmasked study personnel dispensed and collected study materials so that the participant and Investigator remained masked. Endpoint: surface refractive index of the worn right-eye lens, measured on a Metricon M-2010 Prism Coupler, compared with unworn (baseline) values for the same lens types. Continuous data were summarized with n, mean, standard deviation, median, minimum and maximum, and paired t-tests were used to compare unworn with worn values, with p \< 0.05 considered statistically significant.
Interventions
DEVICEkalifilcon A daily disposable spherical soft contact lens
Commercially available Infuse (kalifilcon A) daily disposable spherical soft contact lens, -3.00 D, worn bilaterally for 0.5, 1, 3, 5 and 10 minutes.
DEVICEDailies Total1 (delefilcon A) daily disposable spherical soft contact lens
Commercially available Dailies Total1 (delefilcon A) daily disposable spherical soft contact lens (Alcon), -3.00 D, worn bilaterally for 0.5, 1, 3, 5 and 10 minutes.
DEVICEPrecision1 (verofilcon A) daily disposable spherical soft contact lens
Commercially available Precision1 (verofilcon A) daily disposable spherical soft contact lens (Alcon), -3.00 D, worn bilaterally for 0.5, 1, 3, 5 and 10 minutes.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Participants and the Investigator were masked to the identity of the lens type worn at each visit. Unmasked study personnel, not otherwise involved in assessment, dispensed and collected the study lenses and maintained lens accountability. Because every participant wore all three lens types in the same presentation order, there was no masked assignment of participants to different arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Be 18 years or older and have full legal capacity to volunteer. 2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. 3. Have no active ocular disease or allergic conjunctivitis. 4. Not be using any topical ocular medications. 5. Be willing and able to follow instructions. 6. Have signed a statement of informed consent.
Exclusion criteria
1. Participating in a conflicting study in the opinion of the Investigator. 2. Considered by the Investigator to not be a suitable candidate for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surface Refractive Index of Worn Lenses | Unworn lens (baseline) and immediately after 0.5, 1, 3, 5, and 10 minutes of lens wear | Immediately following lens removal, the right-eye worn lens for each participant was measured for surface refractive index on a Metricon M-2010 Prism Coupler. A new lens pair was worn for each wear time. Surface refractive index is a dimensionless ratio and has no units. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJeffery Schafer, OD, MS
Bausch & Lomb Incorporated
Participant flow
Recruitment details
10 participants were screened for eligibility on April 7, 2021 at the Bausch + Lomb Incorporated Research Clinic, Rochester, New York, United States.
Pre-assignment details
All 10 screened participants met all eligibility criteria and none of the exclusion criteria, and all 10 were assigned to study lens wear. There were no pre-assignment exclusions or withdrawals.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 34.9 years STANDARD_DEVIATION 11.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 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 | 10 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
None listed