Normal Contact Lens Wear
Conditions
Keywords
confocal microscopy, contact lens wear, contact lens solutions, sodium fluorescein
Brief summary
Assess the usefulness of using confocal microscopy to examine changes to the structure of the cornea and to identify any potential consequences of contact lens wear and/or solution use.
Detailed description
Several types of solutions are used in contact lens wear. Each contact lens solution used to disinfect contacts have different ingredients even though they all disinfect the contacts. The objective of this study is to examine the layers of the cornea via HRT in order to assess the usefulness of this technology and to identify any potential consequences of contact lens wear and/or care solution used.
Interventions
DRUGClear Care
neutralized Clear Care
DRUGReNu
overnight soak in solution
DRUGOPTI-FREE
overnight soak in solution
Sponsors
Alcon Research
Christine Sindt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Vision correctable to 20/30 or better in both eyes * Successful soft contact lens wear for at least 2 weeks prior to enrollment
Exclusion criteria
* History of hypersensitivity to any of the components in any of the lens solutions * One functional eye or a monofit lens * Any abnormal slit-lamp finding at baseline * Use of topical ocular meds * Any systemic condition with significant ocular side effects or that interfere with contact lens wear * Enrollment of the investigator's office staff, relatives or members of their respective households * Enrollment of more than one member of the same household
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HRT Corneal Scan | baseline and 2 hours | Looking for cell density |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non Contact Lens Wearers Using Clear Care neutralized Clear Care and no contact lens wear
Clear Care: neutralized Clear Care | 15 |
| Overnight Soaking With Renu ReNu with and without sodium fluorescein
ReNu MultiPlus MPS: overnight soak in solution | 12 |
| Overnight Soaking in Optifree RepleniSH with and without sodium fluorescein
ReNu MultiPlus MPS: overnight soak in solution
OPTI-FREE RepleniSH MPDS: overnight soak in solution | 14 |
| Overnight Soaking in Optifree Replinish ReNu and RepleniSH
OPTI-FREE RepleniSH MPDS: overnight soak in solution | 10 |
| Total | 51 |
Baseline characteristics
| Characteristic | Non Contact Lens Wearers Using Clear Care | Overnight Soaking With Renu | Overnight Soaking in Optifree | Overnight Soaking in Optifree Replinish | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 12 Participants | 14 Participants | 10 Participants | 51 Participants |
| Region of Enrollment United States | 15 Participants | 12 Participants | 14 Participants | 10 Participants | 51 Participants |
| Sex: Female, Male Female | 13 Participants | 11 Participants | 13 Participants | 9 Participants | 46 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 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 | 0 / 15 | 0 / 12 | 0 / 14 | 0 / 10 |
| other Total, other adverse events | 0 / 15 | 0 / 12 | 0 / 14 | 0 / 10 |
| serious Total, serious adverse events | 0 / 15 | 0 / 12 | 0 / 14 | 0 / 10 |
Outcome results
Primary
HRT Corneal Scan
Looking for cell density
Time frame: baseline and 2 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non Contact Wearing Using Clear Care | HRT Corneal Scan | Baseline | 85 cells/mm^3 | Standard Deviation 112 |
| Non Contact Wearing Using Clear Care | HRT Corneal Scan | Two hours | 87 cells/mm^3 | Standard Deviation 110 |
| Overnight Soaking With Renu | HRT Corneal Scan | Two hours | 65 cells/mm^3 | Standard Deviation 48 |
| Overnight Soaking With Renu | HRT Corneal Scan | Baseline | 66 cells/mm^3 | Standard Deviation 44 |
| Overnight Soaking in Optifree | HRT Corneal Scan | Baseline | 49 cells/mm^3 | Standard Deviation 28 |
| Overnight Soaking in Optifree | HRT Corneal Scan | Two hours | 51 cells/mm^3 | Standard Deviation 32 |
| Overnight Soaking in Optifree Replinish | HRT Corneal Scan | Baseline | 63 cells/mm^3 | Standard Deviation 81 |
| Overnight Soaking in Optifree Replinish | HRT Corneal Scan | Two hours | 61 cells/mm^3 | Standard Deviation 77 |