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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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Purpose: To evaluate the efficacy of vectored thermal pulsation treatment in subjects with a history of dry eye disease currently using a topical immunomodulator medication.
Prospective, non-randomized, interventional study. Subjects with bilateral use of a topical immunomodulator drop and a history of dry eye disease were recruited to participate. All subjects underwent a vectored thermal pulsation treatment (LipiFlow). Patients were seen at baseline in a visit immediately prior to treatment and at months 1 and 3 following treatment. Data collected included tear osmolarity, tear break up time (TBUT), tear meniscus height (TMH), meibomian gland function and patient-reported symptoms using the ocular surface disease index (OSDI) questionnaire. Following the 3-month visit, patients were given the option to resume topical immunomodulator therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lipiflow treatment results | Other | A single thermal vectored pulsation treatment of MGD with 3 month results review of treatment to evaluate objective and subjective response. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermal Vectored Pulsation | Device | The LipiFlow® (Johnson & Johnson Vision, USA) Thermal Pulsation System, also known as vectored thermal pulsation, is a treatment that applies localized heat and pressure to the meibomian glands lining the eyelids. The device consists of a console connected to single-use, sterile devices applied to each eye known as activators. The activator includes an eye warmer with a large lens that gently sits on the conjunctiva of each eye. The activator cups the upper and lower eyelid and applies regulated, outward heat to the surface of the palpebral conjunctiva with an air bladder that intermittently provides directional, controlled massage of the eyelids to promote expression of the liquified contents. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects discontinuing Topical Immunomodulator use | OSDI, TBUT, Tear Osmolarity, Meibomian gland expression quantity, TM | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dunes Eye Consultants | Dakota Dunes | South Dakota | 57049 | United States |
Abstract
12months
website
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| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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This study, known as the REDUCE study, was a prospective, non-randomized, single-site, non- comparative study that evaluated the efficacy of a single vectored thermal pulsation (VTP) treatment in patients who were currently being treated with topical immunomodulator agents. This study was conducted in compliance with the Declaration of Helsinski and was reviewed and approved by the WCG institutional review board (IRB). The study is registered in clinictrials.gov. All participants provided written informed consent.
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