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This study will be done with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It will be fit by the investigators and will be assessed and at one week and 1 month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens fitting/evaluation | Experimental | This study will be done with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It will be fit by the investigators and will be assessed and at one week and 1 month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| scleral contact lens | Device | Scleral contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses | Number of Participants with Overall Satisfaction and Desire to Continue Wearing the Study Lenses | 1 month after lens is dispensed |
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Inclusion Criteria:
Exclusion Criteria:
Female subjects who are pregnant, breast-feeding or intend to become pregnant over the course of the study.
Subjects with a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
Note: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity or control, will specifically exclude subjects from eligibility.
Subjects with active ophthalmic disease or abnormality including glaucoma, chorioretinitis, central retinal artery or vein occlusion, intraocular or ocular infection.
Subjects who are participating in any other clinical trial (FDA or other)
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| ID | Title | Description |
|---|---|---|
| FG000 | Lens Fitting/Evaluation | This study was conducted with subjects who already habitually wore scleral contact lenses. The study lens was made with a material that is already widely available and has a new design. It was fit by the investigators and assessed one week and 1 month of wear. scleral contact lens: Scleral contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lens Fitting/Evaluation | This study was conducted with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It was fit by the investigators and assessed and at one week and 1 month. scleral contact lens: Scleral contact lens |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses | Number of Participants with Overall Satisfaction and Desire to Continue Wearing the Study Lenses | Posted | Count of Participants | Participants | 1 month after lens is dispensed |
|
|
Adverse event data was collected at all study visits, including a visit after 1 week and 1 month of lens wear.
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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 | Lens Fitting/Evaluation | This study was conducted with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It was fit by the investigators and assessed and at one week and 1 month. scleral contact lens: Scleral contact lens |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| punctate keratitis | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Fogt | The Ohio State University College of Optometry | 614-292-2020 | Fogt.78@osu.edu |
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| Participants |
|
| 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 |
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| Participants |
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|
| 0 |
| 21 |
| 0 |
| 21 |
| 1 |
| 21 |
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