Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596733
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Vit-A-Vision Clinical Investigation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Investigation to Evaluate the Efficacy and Safety of Vit-A-Vision When Used in Dry Eye Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Symptoms of ocular discomfort include dryness burning stinging photophobia foreign body sensation and contact lens intolerance These symptoms may affect basic daily activities such as reading driving and working with computers In case of moderate to severe conditions dry eye disease is also associated with significant pain Dry eye disease DED affects hundreds of millions of people throughout the world and is one of the most frequent causes of patient visits to eye care practitioners Diagnosing staging and determining the efficacy of therapy in DED is often challenging due to low correlation between signs and symptoms Furthermore its management is complicated because of its multifactorial aetiology In general management approaches begin with conventional low-risk and easily accessible patient-applied therapies such as over-the-counter lubricants for early-stage disease and progress to more advanced therapies for more severe forms of DED In this regard tear supplementation with ocular lubricants artificial tears is considered the first-line therapy and is often the only therapy used in mild to moderate disease They are used in all stages of dry eye either alone in mild to moderate disease or in combination with other treatments in moderate to severe disease Most tear supplements act as lubricants Other actions may include replacement of deficient tear constituents dilution of proinflammatory substances reduction of tear osmolarity and protection against osmotic stress A wide variety of artificial tear products is currently available These products differ with respect to several variables that include electrolyte composition osmolarityosmolality viscosity the presence or absence of preservatives and the presence or absence of compatible solutes Although they are all considered as standard of care in treatment of dry eye disease the effects of many of the available products have not been evaluated in clinical investigations
Vit-A-Vision is an ointment for ophthalmic application that relieves symptoms such as burning irritation slight irritation dryness or tiredness of the eyes
Vit-A-Vision is an ointment for ophthalmic application that relieves symptoms such as burning irritation slight irritation dryness or tiredness of the eyes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None