Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04695795
Status:
UNKNOWN
Last Update Posted:
2021-01-05
First Post:
2020-12-21
Brief Title:
Sea Water in Allergic Conjunctivitis
Sponsor:
University of Valencia
Organization:
University of Valencia
Study Overview
Official Title:
Efficacy and Safety of Seawater in Allergic Conjunctivitis IgE and MMP-9 Tear Levels Antihistaminic Eyedrops Comparative Study
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background and purpose Allergic conjunctivitis has increased alarmingly in recent years The objectives of the study are 1 To establish the safety and efficacy of applying eyewashes in spray form as monotherapy on the symptoms and signs of allergic conjunctivitis 2 To establish the comparative efficacy with other eye drops as antihistamines 3 To measure the modification of immunoglobulin E IgE and matrix metalloproteinase 9 MMP9 levels in the tears
Detailed Description:
Material and methods Prospective study A total of 50 patients will be included A scale from 0 to 3 will be established to quantify the intensity of the different parameters measured A total of 8 symptoms will be studied - itching tearing mucous secretions photophobia foreign body sensation redness rubbing palpebral swelling and 3 signs - palpebral papillae conjunctival hyperemia and corneal involvement dotted keratitis Control at 30 minutes 1 day and 1 month after the application of the treatment At the end of the treatment period the degree of satisfaction with the treatment the desire to continue or abandon it and the need to associate other complementary treatments due to lack of control will also be evaluated All patients will be treated exclusively with seawater isotonic solution in the form of a spray 5 times a day for 1 month A second similar group of patients will be treated with antihistamine eye drops and a third group of patients with both antihistamine eye drops and seawater Tears measurement of immunoglobulin E and matrix metalloproteinase 9 levels will be measured before and after treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None