Sea Water in Allergic Conjunctivitis

NCT04695795 | Unknown

• 1 other identifier: 1236
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Allergic Conjunctivitis

Keywords

seawater; allergic conjunctivitis; IgE tear level; MMP9 tear level

Outcome Measures

Primary Outcomes (3)

• Measure the symptoms, and corneal and conjunctival signs before and after treatment, Bonini scale

  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).

  1 month

• Measure metalloproteinase 9 in tears before and after treatment

  To administer the test, physician collects a tear sample, then activates it with a buffer solution. In 10 minutes, the test will be ready, and will either show a solitary blue line, indicating a negative result, or a blue line accompanied by a red line, which is positive.

  1 month

• Measure immunoglobulin E in tears before and after treatment

  A strip is placed in the lower conjunctival fornix and, when wet with tears, is removed. Signal intensity is dependent on the total Immunoglobulin E level.

  1 month

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Allergic conjunctivitis patientes from 10 yeras old and older

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead

Related Publications (7)

• 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.

  PMID: 17873585 BACKGROUND

• 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.

  PMID: 31614909 BACKGROUND

• 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.

  PMID: 27788889 BACKGROUND

• 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.

  PMID: 27050351 BACKGROUND

• 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.

  PMID: 23834132 BACKGROUND

• 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.

  PMID: 31590324 BACKGROUND

• 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.

  PMID: 12209100 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

IgE and MMP9

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• mariadolores pinazoduran, MD,Prof

  University of Valencia, Spain

  STUDY CHAIR

Central Study Contacts

Manuel J Diaz-Llopis, MD,Prof

CONTACT

+34666530085; manuel.diaz@uv.es

Mariamparo D Guiñoncampos, MD,Prof

CONTACT

+34687962998; amparo.gc@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: January 5, 2021
• Study Start: February 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: December 1, 2022
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share