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Allergic Conjunctivitis clinical trials

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NCT ID: NCT05829499 Completed - Dry Eye Clinical Trials

PMCF Study to Evaluate Performance and Safety of "Xanoftal Next"

Start date: December 2, 2022
Phase: N/A
Study type: Interventional

Dry eye disease (DED), also called keratoconjunctivitis sicca, is a multifactorial disease of the ocular surface characterized by loss of homeostasis of the tear film and accompanied by symptoms such as ocular discomfort and visual disturbance. Patients with moderate-to-severe DED may experience a reduced quality of life due to ocular pain, difficulty in performing daily activities, and depression. Traditionally, dry eye syndrome and allergic conjunctivitis are regarded as 2 different diseases. However, recent literature has shown both conditions share similar characteristics, including several of their signs and symptoms (e.g. red, itchy, watery, and burning eyes). On the other hand, red swollen eyelids, burning sensations, ocular irritation, loss of eyelashes and misdirected eyelashes are also common symptoms of Blepharitis, an inflammatory disorder of eyelids affecting all the age and ethnic groups. First-line therapy for treating dry eye symptoms consists of over the counter (OTC) artificial tear drops, gels, ointments, or lubricants. Manufacturers have developed OTC products that appear to mimic the different layers of the tear film in order to maintain ocular hydration. For these reasons, an interventional, non-comparative, Post Marketing Clinical Follow-up (PMCF) study was planned to evaluate the performance and safety of "Xanoftal Next" used to attenuate symptoms of seasonal allergic conjunctivitis, even when associated with dry eye syndrome. The objectives of the PMCF study are confirmation of the performance, collection of additional safety data regarding expected adverse events and detection of potential unexpected adverse events associated with use of "Xanoftal Next" according to the Instructions for Use (IFU). Each subject, after signing the Informed Consent Form, will enter the screening and baseline phase (the 2 visits will coincide) during which baseline procedures will be completed. At baseline visit, the "Xanoftal Next" product will be administered to the enrolled subject. The patient will perform 2 on-site visits: V0 and V2/EOS. To monitor the safety, 1 phone contact is planned (V1) to check for potential adverse events and concomitant medications intake.

NCT ID: NCT05824000 Completed - Dry Eye Clinical Trials

PMCF Study to Evaluate Performance and Safety of "Optrex Double Action Soothing and Lubricating Drops"

Start date: June 7, 2022
Phase: N/A
Study type: Interventional

Allergic conjunctivitis (or ocular allergy) and dry eye disease (DED) are two major ocular surface disorders affecting millions of people. A typical clinical symptom of allergic conjunctivitis is itching which is also observed in subjects suffering from DED. Common symptoms of DED also include a foreign body sensation, dryness, irritation, burning sensation and visual disturbance. Patients with allergic conjunctivitis or moderate-to-severe DED may experience a reduced quality of life due to ocular pain, difficulty in performing daily activities, and depression. Gel-based artificial tear supplements may offer longer retention times and act as a supplement to the mucin layer. Carbomer (also known as Carbopol polymers) is awater-soluble polymeric resin that exhibit excellent viscoelastic and mucoadhesive properties when compared with other polymers. Carbomer is used in liquid or semisolid pharmaceutical, cosmetics, and ophthalmic formulations as rheology modifiers. Aqueous carbomer gels have been used for the treatment of dry eye and allergic conjunctivitis as they provide prolonged ocular residence time of conventional ophthalmic solutions. Furthermore, carbomer has shown compatibility with many active ingredients, good thermal stability, excellent organoleptic characteristics, and good patient acceptance. For these reasons, an interventional, non-comparative, single-center Post Marketing Clinical Follow-up (PMCF) study was planned to evaluate the performance and safety of "Optrex Double Action soothing and lubricating drops" for itchy and watery eyes. The objectives of the PMCF study are confirmation of the performance, collection of additional safety data regarding expected adverse events and detection of potential unexpected adverse events associated with the use of "Optrex Double Action soothing and lubricating drops" according to the Instructions for Use (IFU). Each subject, after signing the Informed Consent Form, will enter the screening and baseline phase (the 2 visits will coincide) during which baseline procedures will be completed. At baseline visit, "Optrex Double Action soothing and lubricating drops" will be prescribed to the enrolled subject. The patient will perform 2 on-site visits: V0 and V2/EOS. To monitor the safety, 1 phone contact is planned (V1) to check for potential adverse events and concomitant medications intake.

NCT ID: NCT05815758 Completed - Clinical trials for Allergic Conjunctivitis

Evaluation of the Safety and Pharmacokinetics of Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Combination Ophthalmic Solution

Start date: April 20, 2023
Phase:
Study type: Observational

To compare the safety and tolerability of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% combination ophthalmic solution versus its vehicle in healthy adult subjects and in pediatric subjects.

NCT ID: NCT05579730 Completed - Clinical trials for Allergic Conjunctivitis

Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination for the Treatment of Allergic Conjunctivitis

Start date: November 18, 2022
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of Combo (Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution) compared to its individual components and vehicle in a population of subjects with allergic conjunctivitis:

NCT ID: NCT05314621 Completed - Clinical trials for Allergic Conjunctivitis

A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Subjects With Allergic Conjunctivitis

Start date: December 31, 2021
Phase: Phase 4
Study type: Interventional

This is a single-center, randomized, double-masked, parallel study.

NCT ID: NCT05265910 Completed - Clinical trials for Allergic Conjunctivitis

A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Claritin® Tablets 24-Hour in Subjects With Allergic Conjunctivitis

Start date: December 14, 2021
Phase: Phase 4
Study type: Interventional

This is a single-center, randomized, double-masked, parallel study. In this clinical study, the efficacy comparison between Pataday® Once Daily Relief Extra Strength and Claritin® Tablets 24-Hour will be made using the Ora-CAC model, a validated clinical model accepted by regulatory agents for assessing the efficacy of products on the signs and symptoms of allergic conjunctivitis.

NCT ID: NCT05234554 Completed - Clinical trials for Allergic Conjunctivitis

The INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis

Start date: January 21, 2022
Phase: Phase 3
Study type: Interventional

The INVIGORATE 2 Trial: A single-center, randomized, double-masked, crossover design, vehicle-controlled, Phase 3 clinical trial to assess the efficacy and safety of reproxalap ophthalmic solution (0.25%) compared to vehicle in subjects with seasonal allergic conjunctivitis using the environmental exposure chamber (EEC).

NCT ID: NCT04810390 Completed - Clinical trials for Allergic Conjunctivitis

Study to Assess the Safety, Tolerability and Efficacy of Bilastine Ophthalmic Solution 0.6% in Children

Start date: March 26, 2021
Phase: Phase 3
Study type: Interventional

This is a multi-centre, randomised, double blind, placebo-controlled, parallel-group, phase III study to assess the safety, tolerability and efficacy of Bilastine ophthalmic solution 0.6% in children with a documented history of seasonal allergic conjunctivitis (SAC) or perennial allergic conjunctivitis (PAC).

NCT ID: NCT04776096 Completed - Clinical trials for Allergic Conjunctivitis

Efficacy and Toxicity of Bepotastine 1,5% PF vs Olopatadine 0,2% With BAK on Allergic Conjunctivitis Treatment

Start date: March 10, 2021
Phase: Phase 4
Study type: Interventional

The present study will be carried out to evaluate the antiallergic efficacy of Bepotastine besilate 1.5% free of preservatives versus standard treatment with 0.2% Olopatadine hydrochloride with 0.1% benzalkonium chloride as preservative in adult patients diagnosed with allergic conjunctivitis. The antiallergic efficacy will be evaluated by the reduction of ocular signs and symptoms and by the resolution of non-ocular symptoms (rhinorrhea, congestion, and nasal pruritus), as well as the effect of the preservative and its relationship with the cytotoxicity of the ocular surface. Also will evaluate the safety of both products.

NCT ID: NCT04641130 Completed - Clinical trials for Allergic Conjunctivitis

Clinical Validation Study in Allergic Conjunctivitis to Birch Pollen During Allergen Challenge in ALYATEC EEC

Start date: July 13, 2017
Phase: N/A
Study type: Interventional

This is a single center open study designed to determine the concentration of airborne birch pollen inducing an allergic conjunctivitis response in individuals allergic to birch pollen, during allergen exposures in the Alyatec environmental exposure chamber (EEC).