Corneal Staining
Conditions
Keywords
Corneal staining and comfort evaluation in normal, habitual contact lens wearers.
Brief summary
An investigational multi-purpose solution (MPS)was clinically evaluated against Biotrue MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.
Interventions
DEVICEBiotrue MPS
Multi-purpose contact lens care solution
DEVICEInvestigational MPS
Multi-purpose contact lens care solution
Sponsors
Abbott Medical Optics
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* were at least 18 years old; * were experienced contact lens wearers; * were correctable to at least 20/40 or better in both eyes with contact lenses; * were in good general health, with healthy eyes (other than requiring vision correction); * had not worn lenses for at least 12 hours before each baseline visit; * had a corneal staining score no greater than Grade 1 in either eye at time of enrollment; * had previously used an MPS or hydrogen peroxide solution successfully.
Exclusion criteria
* had a confirmed diagnosis of Sjögren's syndrome or other condition that results in a chronic and/or pathologic dry eye condition; * required concurrent ocular medication or have used ocular medication within 24 hours of entering the study; * had a known sensitivity or intolerance to any MPS, study products or ingredient(s); * were currently participating in any other clinical study; * had a condition or are in a situation that, in the investigator's opinion, may put them at significant risk, confound the study results, or interfere significantly with their participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Staining by Wear Time | 1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4 | All participants were contact lenses wearers and were evaluated with a Corneal Staining at 1 hour, 2 hours, 4 hours and end of day. The corneal staining test is performed using fluorescein drops in the eye and ultraviolet illumination to determine if there has been any damage to the cornea from the use of the lens solutions or from the use of the contact lens. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Solution Preference | Day 4 | All subjects were asked which solution they prefer based on comfort level: Biotrue MPS, Investigational MPS, or no difference. |
| Overall Ocular Comfort | Day 4 | All subjects were asked to rate their lens comfort at each visit based on an 11 point scale where 0 meant that the lens could not be tolerated and 10 indicated that the lens could not be felt. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Biotrue/Investigational MPS Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period. | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | Biotrue/Investigational MPS |
|---|---|
| Age, Customized <18 years | 0 participants |
| Age, Customized 18 years of age or older | 29 participants |
| Sex/Gender, Customized Female | 0 participants |
| Sex/Gender, Customized Male | 0 participants |
| Sex/Gender, Customized Unknown | 29 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Primary
Corneal Staining by Wear Time
All participants were contact lenses wearers and were evaluated with a Corneal Staining at 1 hour, 2 hours, 4 hours and end of day. The corneal staining test is performed using fluorescein drops in the eye and ultraviolet illumination to determine if there has been any damage to the cornea from the use of the lens solutions or from the use of the contact lens.
Time frame: 1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4
Population: Corneal Staining Severity at Scheduled Visits (Safety Population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Biotrue | Corneal Staining by Wear Time | Staining at 1 Hour, Day 1 | 19 participants |
| Biotrue | Corneal Staining by Wear Time | Staining at 2 Hours, Day 2 | 19 participants |
| Biotrue | Corneal Staining by Wear Time | Staining at 4 Hours, Day 3 | 21 participants |
| Biotrue | Corneal Staining by Wear Time | Staining at End of Day, Day 4 | 18 participants |
| Investigational MPS | Corneal Staining by Wear Time | Staining at End of Day, Day 4 | 8 participants |
| Investigational MPS | Corneal Staining by Wear Time | Staining at 1 Hour, Day 1 | 15 participants |
| Investigational MPS | Corneal Staining by Wear Time | Staining at 4 Hours, Day 3 | 5 participants |
| Investigational MPS | Corneal Staining by Wear Time | Staining at 2 Hours, Day 2 | 7 participants |
Secondary
Overall Ocular Comfort
All subjects were asked to rate their lens comfort at each visit based on an 11 point scale where 0 meant that the lens could not be tolerated and 10 indicated that the lens could not be felt.
Time frame: Day 4
Population: All subjects who completed the study were included in the analysis per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biotrue | Overall Ocular Comfort | 8.3 score on a scale | Standard Deviation 1.74 |
| Investigational MPS | Overall Ocular Comfort | 8.4 score on a scale | Standard Deviation 1.48 |
Secondary
Subjective Solution Preference
All subjects were asked which solution they prefer based on comfort level: Biotrue MPS, Investigational MPS, or no difference.
Time frame: Day 4
Population: All subjects who completed the study were included in the analysis per protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Biotrue | Subjective Solution Preference | Subject preferred the solution | 6 Participants |
| Biotrue | Subjective Solution Preference | Subject did not prefer the solution | 7 Participants |
| Biotrue | Subjective Solution Preference | Subject reported solutions were about the same | 15 Participants |
| Investigational MPS | Subjective Solution Preference | Subject preferred the solution | 7 Participants |
| Investigational MPS | Subjective Solution Preference | Subject did not prefer the solution | 6 Participants |
| Investigational MPS | Subjective Solution Preference | Subject reported solutions were about the same | 15 Participants |