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| ID | Type | Description | Link |
|---|---|---|---|
| K08EY023264 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Eye Institute (NEI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full-Time Senofilcon A Contact Lens Wear | Experimental | This group will start wearing contact lenses 8 or more hours per day on the first day of wear |
|
| Graduated Senofilcon A Contact Lens Wear | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| Between-Group Difference in Tear Stability as Measured by Non-Invasive Break Up Time (NIBUT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew D Pucker, OD, MS | Ohio State University | Principal Investigator |
| Jeffrey J Walline, OD, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20631232 | Background | Sullivan BD, Whitmer D, Nichols KK, Tomlinson A, Foulks GN, Geerling G, Pepose JS, Kosheleff V, Porreco A, Lemp MA. An objective approach to dry eye disease severity. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6125-30. doi: 10.1167/iovs.10-5390. Epub 2010 Jul 14. | |
| 22475641 | Background | Sullivan BD, Crews LA, Sonmez B, de la Paz MF, Comert E, Charoenrook V, de Araujo AL, Pepose JS, Berg MS, Kosheleff VP, Lemp MA. Clinical utility of objective tests for dry eye disease: variability over time and implications for clinical trials and disease management. Cornea. 2012 Sep;31(9):1000-8. doi: 10.1097/ICO.0b013e318242fd60. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Graduated Senofilcon A Contact Lens Wear |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Units on a Scale | 2 weeks |
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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There was a data collection error, which prevented the study from analyzing CLDEQ-8 scores. This study also intended to included conjunctival staining with lissamine green; however, lissamine green was not available during the conduct of this study, so this outcome was not included.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Pucker | The University of Alabama at Birmingham | 920-579-2900 | apucker@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 3, 2020 | Mar 9, 2021 | Prot_SAP_ICF_000.pdf |
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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. |
| 2 Weeks |
| 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. | 2 Weeks |
| 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. | 2 Weeks |
| 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. | 2 Weeks |
| 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. | 2 Weeks |
| 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. | 2 Weeks |
| 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. | 2 Weeks |
| 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. | 2-Weeks |
| 14508260 | Background | Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003 Oct;22(7):640-50. doi: 10.1097/00003226-200310000-00008. |
| 22775005 | Background | Yang SN, Tai YC, Sheedy JE, Kinoshita B, Lampa M, Kern JR. Comparative effect of lens care solutions on blink rate, ocular discomfort and visual performance. Ophthalmic Physiol Opt. 2012 Sep;32(5):412-20. doi: 10.1111/j.1475-1313.2012.00922.x. Epub 2012 Jul 7. |
| 21948646 | Background | Dougherty BE, Nichols JJ, Nichols KK. Rasch analysis of the Ocular Surface Disease Index (OSDI). Invest Ophthalmol Vis Sci. 2011 Nov 7;52(12):8630-5. doi: 10.1167/iovs.11-8027. |
| 16448840 | Background | Chalmers RL, Begley CG. Dryness symptoms among an unselected clinical population with and without contact lens wear. Cont Lens Anterior Eye. 2006 Mar;29(1):25-30. doi: 10.1016/j.clae.2005.12.004. Epub 2006 Jan 31. |
| 1852401 | Background | Faber E, Golding TR, Lowe R, Brennan NA. Effect of hydrogel lens wear on tear film stability. Optom Vis Sci. 1991 May;68(5):380-4. doi: 10.1097/00006324-199105000-00010. |
| 11220037 | Background | Efron N, Morgan PB, Katsara SS. Validation of grading scales for contact lens complications. Ophthalmic Physiol Opt. 2001 Jan;21(1):17-29. |
| 33771956 | Derived | Pucker AD, Steele K, Rueff E, Franklin QX, McClure K, Savla K, Walline JJ. Contact Lens Adaption in Neophytes. Optom Vis Sci. 2021 Mar 1;98(3):266-271. doi: 10.1097/OPX.0000000000001662. |
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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | seconds | 2 Weeks |
|
|
|
|
| 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. | Posted | Median | Standard Deviation | mm | 2 Weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | mm | 2 Weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 2 Weeks |
|
|
|
|
| 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. | 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. | Posted | 2-Weeks |
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | 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 | 0 | 11 | 0 | 11 | 0 | 11 |
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| .58 |
| Superiority |
| Two Weeks (Depth) |
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| Superiority |
| Depth | Fisher Exact | .50 | Superiority |