Contact Lens Comfort
Conditions
Keywords
Contact Lenses, Neophytes, Contact Lens Adaptation, Randomized
Brief summary
Eye care professionals prescribe contact lenses to new wearers on a daily basis, and it is common practice for practitioners to educate their patients to gradually increase their contact lens wear time over their first few days of use; however, there is no scientific basis in the literature for this practice. This study will compare the ocular health and comfort of new contact lens wearers who are randomly assigned to begin contact lens wear with increasing wearing time versus those who immediately start full-time wear (eight hours or more/day). The increasing wearing time group will wear daily wear contact lenses (Acuvue Oasys) for two, four, six, eight, and eight or more hours on the first, second, third, fourth, and fifth days, respectively. The other group will be instructed to wear the same contact lenses for eight or more hours per day, starting with the first day of wear. Both groups of subjects will have their eye health and comfort evaluated at baseline, one, and two weeks with a lighted-microscope and eye comfort surveys. Subjects will also keep a daily log of eye comfort with a visual analog scale survey at home. All subjects will learn how to wear and take care of contact lenses. They will also receive a prescription for contact lenses at the conclusion if they wish to continue wearing the study contact lenses.
Interventions
DEVICEsenofilcon A
Sponsors
National Institutes of Health (NIH)
National Eye Institute (NEI)
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Has had a completed comprehensive eye exam within the past 6 months * Able to wear spherical senofilcon A contact lenses * Able to use Opti-Free PureMoist contact lens solution
Exclusion criteria
* Any prior contact lens use * Topical eye drops within the last two hours of the study visit * Known systemic health conditions known to alter tear film physiology * History of severe ocular trauma * Active ocular infection * Active ocular inflammation * Known hypersensitivity to diagnostic eye drops * Pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Between-Group Difference in Eye Comfort as Measured by the Ocular Surface Disease Index (OSDI) | 2 weeks | This is an eye comfort survey. The Ocular Surface Disease Index (OSDI) is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Between-Group Difference in Tear Stability as Measured by Non-Invasive Break Up Time (NIBUT) | 2 Weeks | Non-Invasive Break Up Time (NIBUT) is a measure of tear stability. The range is 0 to 60 seconds with longer times being better tear stability. |
| Between-Group Difference in Tear Volume as Measured by Tear Meniscus Height (TMH) | 2 Weeks | Tear Meniscus Height (TMH) was used at a measure of tear volume. The range is 0.0 to 2.0 mm with higher values being more tear volume. |
| Between-Group Difference in Bulbar Conjunctival Redness as Measured With the Keratograph 5M | 2 Weeks | Eye redness was measured via bulbar conjunctival redness as measured with the Keratograph 5M. The range is 0 to 4 units with lower numbers being better. |
| Between-Group Difference in Upper and Lower Eyelid Blepharitis | 2 Weeks | A slit-lamp biomicroscope was used to document eyelid blepharitis with a 0-3 scale by each eyelid with higher scores being worse blepharitis. |
| Between-Group Difference in Visual Acuity as Measured With the Bailey-Lovie Chart | 2 weeks | The investigator will measure the subject's visual acuity with a Bailey-Lovie high-contrast paper (logMAR) chart. logMAR is a method used to observe visual acuity. Smaller numbers are better scores. |
| Between-Group Difference in Tear Volume as Measured by Schirmer's Test I | 2 Weeks | Tear volume was assessed with Schirmer's Test I test over 5 mins. This test has a 0-35 mm range with higher values being better tear volume. |
| Between-Group Difference in End of Day Contact Lens Comfort as Measured With a Visual Analog Scale (VAS) | 2 Weeks | End of day contact lens comfort was measured with a visual analog scale (1-100 scale). Higher scores indicate better comfort. |
| Between-Group Difference in Contact Lens Dry Eye-8 Questionnaire (CLDEQ-8) Scores | 2-Weeks | Contact lens comfort was measured with a scale (1-37 scale). Lower scores indicate better comfort. |
| Between-Group Difference in Corneal Sodium Fluorescein Staining | 2 Weeks | The Brien Holden Vision Institute grading scale was used to evaluate staining by observing the eye after applying sodium fluorescein. Scores were given for the extent (0-20 units), depth (0-20 units), type (0-20 units) of staining. Higher scores indicate worse staining. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Full-Time Senofilcon A Contact Lens Wear This group will start wearing contact lenses 8 or more hours per day on the first day of wear
senofilcon A | 12 |
| Graduated Senofilcon A Contact Lens Wear This group will start wearing contact lenses on a graduated schedule (day 1 = 2 hours, day 2 = 4 hours, day 3 = 6 hours, day 4 = 8 hours, day 5 = 8 or more hours).
senofilcon A | 13 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Graduated Senofilcon A Contact Lens Wear | Total | Full-Time Senofilcon A Contact Lens Wear |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 24 Participants | 11 Participants |
| Age, Continuous | 24.1 Years | 23.45 Years | 22.8 Years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 13 Participants | 25 Participants | 12 Participants |
| Sex: Female, Male Female | 4 Participants | 11 Participants | 7 Participants |
| Sex: Female, Male Male | 9 Participants | 14 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 11 |
| other Total, other adverse events | 0 / 9 | 0 / 11 |
| serious Total, serious adverse events | 0 / 9 | 0 / 11 |
Outcome results
Primary
Between-Group Difference in Eye Comfort as Measured by the Ocular Surface Disease Index (OSDI)
This is an eye comfort survey. The Ocular Surface Disease Index (OSDI) is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Full-Time Senofilcon A Contact Lens Wear | Between-Group Difference in Eye Comfort as Measured by the Ocular Surface Disease Index (OSDI) | 10.8 Units on a Scale | Standard Deviation 8.5 |
| Graduated Senofilcon A Contact Lens Wear | Between-Group Difference in Eye Comfort as Measured by the Ocular Surface Disease Index (OSDI) | 16.3 Units on a Scale | Standard Deviation 18.8 |
p-value: 0.83Wilcoxon (Mann-Whitney)
Secondary
Between-Group Difference in Bulbar Conjunctival Redness as Measured With the Keratograph 5M
Eye redness was measured via bulbar conjunctival redness as measured with the Keratograph 5M. The range is 0 to 4 units with lower numbers being better.
Time frame: 2 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Full-Time Senofilcon A Contact Lens Wear | Between-Group Difference in Bulbar Conjunctival Redness as Measured With the Keratograph 5M | 0.69 units on a scale | Standard Deviation 0.37 |
| Graduated Senofilcon A Contact Lens Wear | Between-Group Difference in Bulbar Conjunctival Redness as Measured With the Keratograph 5M | 0.59 units on a scale | Standard Deviation 0.09 |
p-value: 0.14Wilcoxon (Mann-Whitney)
Secondary
Between-Group Difference in Contact Lens Dry Eye-8 Questionnaire (CLDEQ-8) Scores
Contact lens comfort was measured with a scale (1-37 scale). Lower scores indicate better comfort.
Time frame: 2-Weeks
Population: The electronic data capture system did not record these data correctly, so we could not analyze it. Therefore, data from the CLDEQ-8 are not valid.
Secondary
Between-Group Difference in Corneal Sodium Fluorescein Staining
The Brien Holden Vision Institute grading scale was used to evaluate staining by observing the eye after applying sodium fluorescein. Scores were given for the extent (0-20 units), depth (0-20 units), type (0-20 units) of staining. Higher scores indicate worse staining.
Time frame: 2 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Full-Time Senofilcon A Contact Lens Wear | Between-Group Difference in Corneal Sodium Fluorescein Staining | Two Weeks (Extent) | 0.0 units on a scale | Standard Deviation 0.1 |
| Full-Time Senofilcon A Contact Lens Wear | Between-Group Difference in Corneal Sodium Fluorescein Staining | Two Weeks (Type) | 0.0 units on a scale | Standard Deviation 0 |
| Full-Time Senofilcon A Contact Lens Wear | Between-Group Difference in Corneal Sodium Fluorescein Staining | Two Weeks (Depth) | 0.0 units on a scale | Standard Deviation 0.1 |
| Graduated Senofilcon A Contact Lens Wear | Between-Group Difference in Corneal Sodium Fluorescein Staining | Two Weeks (Extent) | 0.3 units on a scale | Standard Deviation 0.4 |
| Graduated Senofilcon A Contact Lens Wear | Between-Group Difference in Corneal Sodium Fluorescein Staining | Two Weeks (Type) | 0.2 units on a scale | Standard Deviation 0.4 |
| Graduated Senofilcon A Contact Lens Wear | Between-Group Difference in Corneal Sodium Fluorescein Staining | Two Weeks (Depth) | 0.2 units on a scale | Standard Deviation 0.3 |
Comparison: Extentp-value: 0.5Fisher Exact
Comparison: Typep-value: 0.76Fisher Exact
Comparison: Depthp-value: 0.5Fisher Exact
Secondary
Between-Group Difference in End of Day Contact Lens Comfort as Measured With a Visual Analog Scale (VAS)
End of day contact lens comfort was measured with a visual analog scale (1-100 scale). Higher scores indicate better comfort.
Time frame: 2 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Full-Time Senofilcon A Contact Lens Wear | Between-Group Difference in End of Day Contact Lens Comfort as Measured With a Visual Analog Scale (VAS) | 89.0 score on a scale | Standard Deviation 9.7 |
| Graduated Senofilcon A Contact Lens Wear | Between-Group Difference in End of Day Contact Lens Comfort as Measured With a Visual Analog Scale (VAS) | 81.8 score on a scale | Standard Deviation 18.7 |
p-value: 0.47Wilcoxon (Mann-Whitney)
Secondary
Between-Group Difference in Tear Stability as Measured by Non-Invasive Break Up Time (NIBUT)
Non-Invasive Break Up Time (NIBUT) is a measure of tear stability. The range is 0 to 60 seconds with longer times being better tear stability.
Time frame: 2 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Full-Time Senofilcon A Contact Lens Wear | Between-Group Difference in Tear Stability as Measured by Non-Invasive Break Up Time (NIBUT) | 11.7 seconds | Standard Deviation 7 |
| Graduated Senofilcon A Contact Lens Wear | Between-Group Difference in Tear Stability as Measured by Non-Invasive Break Up Time (NIBUT) | 9.8 seconds | Standard Deviation 2.7 |
p-value: 0.94Wilcoxon (Mann-Whitney)
Secondary
Between-Group Difference in Tear Volume as Measured by Schirmer's Test I
Tear volume was assessed with Schirmer's Test I test over 5 mins. This test has a 0-35 mm range with higher values being better tear volume.
Time frame: 2 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Full-Time Senofilcon A Contact Lens Wear | Between-Group Difference in Tear Volume as Measured by Schirmer's Test I | 15.9 mm | Standard Deviation 8.8 |
| Graduated Senofilcon A Contact Lens Wear | Between-Group Difference in Tear Volume as Measured by Schirmer's Test I | 21.2 mm | Standard Deviation 12.5 |
p-value: 0.32Wilcoxon (Mann-Whitney)
Secondary
Between-Group Difference in Tear Volume as Measured by Tear Meniscus Height (TMH)
Tear Meniscus Height (TMH) was used at a measure of tear volume. The range is 0.0 to 2.0 mm with higher values being more tear volume.
Time frame: 2 Weeks
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Full-Time Senofilcon A Contact Lens Wear | Between-Group Difference in Tear Volume as Measured by Tear Meniscus Height (TMH) | 0.31 mm | Standard Deviation 0.09 |
| Graduated Senofilcon A Contact Lens Wear | Between-Group Difference in Tear Volume as Measured by Tear Meniscus Height (TMH) | 0.32 mm | Standard Deviation 0.12 |
p-value: 0.96Wilcoxon (Mann-Whitney)
Secondary
Between-Group Difference in Upper and Lower Eyelid Blepharitis
A slit-lamp biomicroscope was used to document eyelid blepharitis with a 0-3 scale by each eyelid with higher scores being worse blepharitis.
Time frame: 2 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Full-Time Senofilcon A Contact Lens Wear | Between-Group Difference in Upper and Lower Eyelid Blepharitis | Two Weeks (Lower Eyelid) | 0.4 units on a scale | Standard Deviation 0.7 |
| Full-Time Senofilcon A Contact Lens Wear | Between-Group Difference in Upper and Lower Eyelid Blepharitis | Two Weeks (Upper Eyelid) | 1.1 units on a scale | Standard Deviation 1.3 |
| Graduated Senofilcon A Contact Lens Wear | Between-Group Difference in Upper and Lower Eyelid Blepharitis | Two Weeks (Upper Eyelid) | 1.3 units on a scale | Standard Deviation 0.8 |
| Graduated Senofilcon A Contact Lens Wear | Between-Group Difference in Upper and Lower Eyelid Blepharitis | Two Weeks (Lower Eyelid) | 0.8 units on a scale | Standard Deviation 0.8 |
p-value: 0.27Fisher Exact
Comparison: This is for the lower eyelid evaluation.p-value: 0.58Fisher Exact
Secondary
Between-Group Difference in Visual Acuity as Measured With the Bailey-Lovie Chart
The investigator will measure the subject's visual acuity with a Bailey-Lovie high-contrast paper (logMAR) chart. logMAR is a method used to observe visual acuity. Smaller numbers are better scores.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Full-Time Senofilcon A Contact Lens Wear | Between-Group Difference in Visual Acuity as Measured With the Bailey-Lovie Chart | 0.03 units on a scale | Standard Deviation 0.05 |
| Graduated Senofilcon A Contact Lens Wear | Between-Group Difference in Visual Acuity as Measured With the Bailey-Lovie Chart | 0.01 units on a scale | Standard Deviation 0.08 |
p-value: 0.95Wilcoxon (Mann-Whitney)