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Allergic ConjunctivitisNCT04695795

Sea Water in Allergic Conjunctivitis

An observational study of Allergic Conjunctivitis, run by University of Valencia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 10 to 80 years
Conditions the study is for
Allergic Conjunctivitis
How many people
50 participants
Where
No sites listed yet
Study dates
1 Feb 2021to 1 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 80 years
  • All sexes
  • Child, Adult, Older adult

Study population: Allergic conjunctivitis patientes from 10 yeras old and older

Who may be able to join

  • The inclusion criteria were patients with mild or moderate allergic conjunctivitis as detailed in Table I. The minimum to be included in the study was the presence in both eyes of three symptoms and one sign (Table II). Among the symptoms, the presence of itching and two more of the following were essential: redness, tearing, foreign body sensation, rubbing, mucous secretion, and/or palpebral swelling sensation. Among the signs, conjunctival hyperemia, papillae in the palpebral conjunctiva, and/or corneal affectation in the form of dotted keratitis were evaluated.
  • 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
Show all 13Show fewer
  • Redness - Pads
  • Foreign body sensation - palpebral swelling
  • Photophobia
  • Eyelid swollen sensation
  • Mucous secretions
  • Rubbing
  • Tears

Who cannot join

  • 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.
Show all 13Show fewer
  • 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

Trial locations and contacts

No sites are listed yet.

Manuel J Diaz-Llopis, MD,Prof contact

+34666530085

manuel.diaz@uv.es

Mariamparo D Guiñoncampos, MD,Prof contact

+34687962998

amparo.gc@hotmail.com

About this study

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

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.

Read the 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.

Keywords
seawater, allergic conjunctivitis, IgE tear level, MMP9 tear level
Medical subject headings
Conjunctivitis, Allergic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 1 month

  2. 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.

    Measured: 1 month

  3. 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.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2021
  2. Study start1 Feb 2021 (estimated)
  3. Primary completion1 May 2021 (estimated)
  4. Study completion1 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04695795
Sponsor's protocol ID
1236
Status last verified
Dec 2020
First submitted
21 Dec 2020
Last updated
5 Jan 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17873585

  • 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.

    PubMed 31614909

  • 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.

    PubMed 27788889

  • 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.

    PubMed 27050351

  • 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.

    PubMed 23834132

  • 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.

    PubMed 31590324

  • 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.

    PubMed 12209100

Questions about this trial

What is this clinical trial studying?

An observational study of Allergic Conjunctivitis, run by University of Valencia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Manuel J Diaz-Llopis, MD,Prof (+34666530085, manuel.diaz@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure the symptoms, and corneal and conjunctival signs before and after treatment, Bonini scale (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04695795, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.

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