NCT04695795

Sea Water in Allergic Conjunctivitis

Efficacy and Safety of Seawater in Allergic Conjunctivitis. IgE and MMP-9 Tear Levels. Antihistaminic Eyedrops Comparative Study.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: University of Valencia · Academic / Other
• Sex: All
• Age: 10 Years – 80 Years
• Healthy volunteers: —

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.

Conditions

• Allergic Conjunctivitis

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-05-01
• Completion: 2022-12-01
• First posted: 2021-01-05
• Last updated: 2021-01-05