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| Name | Class |
|---|---|
| Bausch & Lomb Incorporated | INDUSTRY |
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This study will determine how multifocal contact lens correction affects symptoms of discomfort and asthenopia in a group of myopic contact lens wearers in the non-presbyopic age range (ages 30-40 years).
The purpose of this study is to determine how multifocal contact lenses affect contact lens comfort in non-presbyopic contact lens wearers. Current soft contact lens wearers who have symptoms of discomfort in their contact lenses will be recruited. Each subject (n = 84) will wear a single vision soft contact lens (Ultra single vision spherical lens) for two weeks and a low add power multifocal (Ultra for Presbyopia) for two weeks. Half of the subjects will wear the single vision lens first, and half of the subjects will wear the multifocal lens first. Initial lens group will be chosen randomly. Subjects will complete surveys that assess their vision and comfort which each lens, and ocular surface and accommodative/binocular vision status will be evaluated at the initial dispense and after wearing each lens for two weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Vision First | Experimental | Subjects in this group will receive the single vision spherical (Bausch + Lomb ULTRA®) lens for the first two weeks and be crossed over to the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lens for the second two weeks.Therefore, this group will receive both study interventions. |
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| Multifocal first | Experimental | Subjects in this group will receive the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lenses for the first two weeks and be crossed over to the single vision spherical (Bausch + Lomb ULTRA®) lens for the second two weeks. Therefore, this group will receive both study interventions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multifocal Contact Lens | Device | The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score | After wearing each lens type (single vision and multifocal) for 2 weeks, subjects will complete the CLDEQ-8, a survey that assesses symptoms of contact lens discomfort, to reports their symptoms of discomfort with each lens type. CLDEQ-8 scores with the multifocal will be compared to CLDEQ-8 scores of the single vision lens and the subjects' habitual contact lenses to determine if the multifocal improved comfort. Min-Max CLDEQ-8 range: 0-37 points Higher point values indicate more/worse symptoms | Baseline and after 2 weeks of contact lens wear with each study lens (single vision and multifocal) |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University College of Optometry | Columbus | Ohio | 43210 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Vision First | Subjects in this group will receive the single vision spherical (Bausch + Lomb ULTRA®) lens for the first two weeks and be crossed over to the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lens for the second two weeks. Single Vision First, Multifocal Second: The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks first, then the multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks |
| FG001 | Multifocal First | Subjects in this group will receive the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lenses for the first two weeks and be crossed over to the single vision spherical (Bausch + Lomb ULTRA®) lens for the second two weeks. Multifocal First, Single Vision Second: The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks first, then the single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Vision First | Subjects in this group will receive the single vision spherical (Bausch + Lomb ULTRA®) lens for the first two weeks and be crossed over to the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lens for the second two weeks. Single Vision First, Multifocal Second: The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks first, then the multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score | After wearing each lens type (single vision and multifocal) for 2 weeks, subjects will complete the CLDEQ-8, a survey that assesses symptoms of contact lens discomfort, to reports their symptoms of discomfort with each lens type. CLDEQ-8 scores with the multifocal will be compared to CLDEQ-8 scores of the single vision lens and the subjects' habitual contact lenses to determine if the multifocal improved comfort. Min-Max CLDEQ-8 range: 0-37 points Higher point values indicate more/worse symptoms | Posted | Mean | Standard Deviation | scores on a scale | Baseline and after 2 weeks of contact lens wear with each study lens (single vision and multifocal) |
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Data from potential adverse events were collected for the duration of the study for each subject. From baseline to final visit, each subject participated in the study for approximately 4-6 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 | Single Vision Contact Lens | All subjects wore the single vision (Bausch + Lomb ULTRA®) lens for approximately 2 weeks during the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Rueff, OD, PhD | Marshall B. Ketchum University (The Ohio State University during study data collection) | 7654145644 | em.rueff@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 21, 2017 | Dec 28, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001248 | Asthenopia |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| Single Vision Contact Lens | Device | The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks |
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| BG001 | Multifocal First | Subjects in this group will receive the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lenses for the first two weeks and be crossed over to the single vision spherical (Bausch + Lomb ULTRA®) lens for the second two weeks. Multifocal First, Single Vision Second: The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks first, then the single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Data regarding gender of participants were not recorded for this study | Data regarding gender of participants were not recorded for this study. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Data regarding race/ethnicity were not analyzed for this study. | Data regarding race/ethnicity were not analyzed for this study. | Count of Participants | Participants |
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| Contact Len Dry Eye Questionnaire-8 (CLDEQ-8) Score with Habitual Contact Lenses | Min-Max range: 0-37 points Higher point values indicate more/worse symptoms | Mean | Standard Deviation | scores on a scale |
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| Spherical Equivalent Refractive Error (Right Eye) | Mean | Standard Deviation | diopters |
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| Spherical Equivalent Refractive Error (Left Eye) | Mean | Standard Deviation | diopters |
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| Accommodative Lag with 2 Diopter Target | Accommodative Lag was measured with an autorefractor while the the subject was viewing a visual target at at 50 cm (2 diopter visual demand) and the single vision study lens. Accommdative lag is reported with the single vision lens only because the multifocal lens induces power changes that affect autorefractor measurements. | Mean | Standard Deviation | diopters |
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| Accommodative Lag with 4 Diopter Target | Accommodative Lag was measured with an autorefractor while the the subject was viewing a visual target at at 25 cm (4 diopter visual demand) and the single vision study lens. Accommdative lag is reported with the single vision lens only because the multifocal lens induces power changes that affect autorefractor measurements. | Mean | Standard Deviation | diopters |
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| OG001 |
| CLDEQ-8 With Single Vision Contact Lens |
Mean CLDEQ-8 score across both groups treatment groups (single vision first and multifocal first)(n = 84) with the single vision contact lens |
| OG002 | CLDEQ-8 With Habitual Contact Lenses | Mean CLDEQ-8 score across both groups (single vision first and multifocal first)(n=84) at baseline with each subject's habitual contact lenses |
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| 0 |
| 84 |
| 0 |
| 84 |
| 0 |
| 84 |
| EG001 | Multifocal Contact Lens | All subjects wore the multifocal vision (Bausch + Lomb ULTRA® for Presbyopia) lens for approximately 2 weeks during the study. | 0 | 84 | 0 | 84 | 0 | 84 |
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