Sea Water in Allergic Conjunctivitis

NCT ID: NCT04695795

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-12-01

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.

Conditions

Allergic Conjunctivitis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

Table 1 Degree of conjunctivitis I Mild II Moderate III Severe IV Blinding

Conjunctiva bulbar: congestion granuloma Conjunctiva tarsal: micropapillae 1mm giant >1 mm cobblestone Corneal staining : micro macro shield ulcer Limbal affectation: < 180 degrees >180 degrees insufficiency limbo/pannus/ vascularization corneal

Table 2 Signs and symptoms evaluated initially and at each visit

Symptoms Signs:

• Itching - Conjunctival Hyperemia
• Redness - Pads
• Foreign body sensation - palpebral swelling
• Photophobia
• Eyelid swollen sensation
• Mucous secretions
• Rubbing
• Tears

Exclusion Criteria

• blepharitis
• meibomian gland dysfunction syndrome (MGS)
• dry eye disease
• topical eye drug such as cyclosporine, tacrolimus, interferon-alpha, mitomycin
• previous eye surgery
• corneal refractive surgery.
• use of contact lenses
• glaucoma
• pterygium
• ocular pemphigoid
• anti-allergic vaccines
• oral or subcutaneous drugs such as antihistamines, anti-leukotrienes (montelukast), corticoids, immunosuppressants or biological drugs.
• rhinitis and dermatitis

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

mariadolores pinazoduran, MD,Prof

Role: STUDY_CHAIR

University of Valencia, Spain

Central Contacts

Manuel J Diaz-Llopis, MD,Prof

Role: CONTACT

manuel.diaz@uv.es

+34666530085

Mariamparo D Guiñoncampos, MD,Prof

Role: CONTACT

amparo.gc@hotmail.com

+34687962998

References

Bonini S, Sacchetti M, Mantelli F, Lambiase A. Clinical grading of vernal keratoconjunctivitis. Curr Opin Allergy Clin Immunol. 2007 Oct;7(5):436-41. doi: 10.1097/ACI.0b013e3282efb726.

Reference Type: BACKGROUND

PMID: 17873585 (View on PubMed)

Yazu H, Kozuki N, Dogru M, Shibasaki A, Fujishima H. The Effect of Long-Term Use of an Eyewash Solution on the Ocular Surface Mucin Layer. Int J Mol Sci. 2019 Oct 13;20(20):5078. doi: 10.3390/ijms20205078.

Reference Type: BACKGROUND

PMID: 31614909 (View on PubMed)

Yazu H, Dogru M, Matsumoto Y, Fujishima H. Efficacy and safety of an eye wash solution in allergic conjunctivitis after conjunctival allergen challenge. Ann Allergy Asthma Immunol. 2016 Nov;117(5):565-566. doi: 10.1016/j.anai.2016.08.030. Epub 2016 Oct 24. No abstract available.

Reference Type: BACKGROUND

PMID: 27788889 (View on PubMed)

Gokhale NS. Systematic approach to managing vernal keratoconjunctivitis in clinical practice: Severity grading system and a treatment algorithm. Indian J Ophthalmol. 2016 Feb;64(2):145-8. doi: 10.4103/0301-4738.179727.

Reference Type: BACKGROUND

PMID: 27050351 (View on PubMed)

Yasar M, Uysal IO, Altuntas EE, Cevit O, Muderris S. Effects of topical sprays on allergy-induced nasal obstruction in children. Kulak Burun Bogaz Ihtis Derg. 2013 Jul-Aug;23(4):217-24. doi: 10.5606/kbbihtisas.2013.27132.

Reference Type: BACKGROUND

PMID: 23834132 (View on PubMed)

Dermer H, Theotoka D, Lee CJ, Chhadva P, Hackam AS, Galor A, Kumar N. Total Tear IgE Levels Correlate with Allergenic and Irritating Environmental Exposures in Individuals with Dry Eye. J Clin Med. 2019 Oct 4;8(10):1627. doi: 10.3390/jcm8101627.

Reference Type: BACKGROUND

PMID: 31590324 (View on PubMed)

Kumagai N, Yamamoto K, Fukuda K, Nakamura Y, Fujitsu Y, Nuno Y, Nishida T. Active matrix metalloproteinases in the tear fluid of individuals with vernal keratoconjunctivitis. J Allergy Clin Immunol. 2002 Sep;110(3):489-91. doi: 10.1067/mai.2002.126379.

Reference Type: BACKGROUND

PMID: 12209100 (View on PubMed)

Other Identifiers

1236

Identifier Type: -

Identifier Source: org_study_id