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This study is designed to evaluate the clinical utility and safety of the Visant Medical Canalicular Plug compared to a commercially available canalicular plug.
The objective of this study is to evaluate the clinical utility and safety of the Visant Medical Canalicular Plug compared to a commercially available canalicular plug over 6 months of subject follow-up.
Study subjects who are eligible for enrollment and have provided written informed consent will be randomized in a 2:1 ratio (i.e., 2 subjects randomized to the Visant Medical Canalicular Plug for every 1 subject randomized to a commercially available canalicular plug). All study subjects will be treated bilaterally with plugs placed in the inferior canaliculi.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visant Medical Canalicular Plug | Experimental | Bilateral placement of the Visant Canalicular Plug inserted on Day 1 |
|
| Commercially available canalicular plug | Active Comparator | Bilateral placement of commercially available canalicular plug inserted on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visant Medical Canalicular Plug | Device | Plug is inserted into the inferior canaliculi and assessed for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Schirmer's score from baseline to Month 3 compared to commercially available plug | Non-inferiority hypothesis. Higher Score using this continuous variable equates to larger tear film | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of responders achieving improvement from Baseline in Ocular Surface Disease Index (OSDI) score by a Minimal Clinically Important Difference (MCID). | Non-inferiority hypothesis. Scale of 0-100. Lower OSDI score means fewer symptoms. | 3 months |
| Mean change in tear meniscus height from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger Albright | Ora Clinical Research Organization | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schwartz Laser Eye Center | Scottsdale | Arizona | 85260 | United States | ||
| Eye Research Foundation, Inc. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 14, 2023 | Aug 7, 2023 | 3 | ||
| Aug 30, 2023 |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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All study subjects will receive treatment. Study subjects will be randomized (2:1 ratio) with 2 subjects randomized to receive the Visant Medical Canalicular Plug for every 1 subject randomized to receive the commercially available canalicular plug.
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Subjects will be masked to their assignment to either the treatment or control group. Clinical personnel who perform clinical assessments will also be masked to the subjects' assignment to either the treatment or control group ("masked evaluators"). The eye care professional who inserts the test and control devices will not be masked and will not be eligible to perform follow-up evaluations.
| Commercially available canalicular plug | Device | Plug is inserted into the inferior canaliculi and assessed for 6 months |
|
Null hypothesis of no improvement from baseline. Larger measurement equates to larger tear film. |
| Month 3 |
| Mean change in OSDI score from baseline | Null hypothesis of no improvement from baseline. Non-inferiority hypothesis. Scale of 0-100. Lower OSDI score means fewer symptoms. | Month 3 |
| Mean change in corneal staining score from baseline (NEI workshop scale) | Null hypothesis of no improvement from baseline. Scale is 0-15. More staining is associated with more severe dry eye. | Month 3 |
| Mean change in tear meniscus height from baseline | Null hypothesis of no improvement from baseline. Larger measurement equates to larger tear film. | Month 6 |
| Mean change in OSDI score from baseline | Null hypothesis of no improvement from baseline. Non-inferiority hypothesis. Scale of 0-100. Lower OSDI score means fewer symptoms. | Month 6 |
| Mean change in corneal staining score from baseline (NEI workshop scale) | Null hypothesis of no improvement from baseline. Scale is 0-15. More staining is associated with more severe dry eye. | Month 6 |
| Mean change in tear break up time from baseline | Null hypothesis of no improvement from baseline. Increased time equates to more stable tear film | Month 3 |
| Mean change in Schirmer score from baseline | Null hypothesis of no improvement from baseline. Higher Score using this continuous variable equates to larger tear film | Month 6 |
| Mean change in tear break up time from baseline | Null hypothesis of no improvement from baseline. Increased time equates to more stable tear film | Month 6 |
| Newport Beach |
| California |
| 92663 |
| United States |
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
| Piedmont Eye, Inc. | Lynchburg | Virginia | 24502 | United States |
| See Clearly Vision | McLean | Virginia | 22102 | United States |
| Sep 25, 2023 |
| 4 |