Active clinical trials for "Conjunctivitis"

The purpose of this study is to evaluate the efficacy of ST266 ophthalmic drops compared to placebo for the treatment of the signs and symptoms of allergic conjunctivitis.

Intranasal corticosteroids are accepted as safe and effective first-line therapy for allergic rhinitis, especially in treatment of persistent symptoms. Budesonide, a non-halogenic glucocorticoid, is widely used in the management of inflammatory mucosal diseases like chronic obstructive pulmonary disease, asthma and allergic rhinitis. It is a highly fat-soluble substance with low water solubility and is presented as dispersion in marketed nasal sprays, like Rhinocort aqua 64. The maximum therapeutic efficacy of Rhinocort aqua is obtained after an application period of 7 to 14 days. In Budesolv, the solubility of budesonide is considerably increased suggesting that the same therapeutic efficacy can be reached with a lower dose. Better bioavailability of the dissolved drug promise an earlier onset of therapeutic efficacy. The current trial is undertaken to demonstrate these two effects. Subjects suffering from grass pollen allergic rhinitis will be challenged with grass pollen in a challenge chamber. Allergic subjects will be treated with two actuations (50 μl) of respective study treatment into each nostril once daily for 8 days. The total daily budesonide dose will be 40 μg per subject for Budesolv 10 and 256 μg per subject for Rhinocort® aqua 64. The primary objective of the study is to show non-inferiority of Budesolv 10 to Rhinocort® aqua 64. On day 8 grass pollen allergic patients will be challenged with grass pollen over a period of 6 hours and subjective nasal symptoms (congestion, sneezing, itching, rhinorrhea) as well as objective symptoms (nasal airflow, nasal secretion) will be assessed every 15 minutes. The second objective of the trial is to demonstrate an early on-set of therapeutic efficacy of Budesolv 10 compared to Rhinocort aqua. On day 1, grass pollen allergic patients will be challenged with grass pollen allergen in the challenge chamber over a period of 6 hours. After 1 hour 45 minutes, patients will receive their first dosage of the respective nasal spray treatment. During the 6 hour grass pollen challenge, subjective and objective endpoints will be measured every 15 minutes. To eliminate an individual bias based on expectations, the effect and onset of action is also compared to the effects of a suitable placebo. The same set of study participants will receive all three interventions in three consecutive treatment periods.

To evaluate the efficacy and safety of PR013 topical ophthalmic drops (0.045% and 0.06%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis using a modified Conjunctival Allergen Challenge Model (Ora-CAC®).

Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic solution PRO-174 versus Sophixín Ofteno®, elaborated by Laboratorios Sophia, S.A. of C.V. on the ocular surface of ophthalmologically and clinically healthy subjects. Goals: To evaluate the safety and tolerability of the formulation PRO-174 manufactured by Laboratorios Sophia, S.A. of C.V. on the ocular surface of clinically healthy subjects. Hypothesis: The ophthalmic solution PRO-174 presents a safety and tolerability profile similar to the comparator in healthy subjects.

The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy (SCIT) with House Dust Mite (HDM) extract in patients with rhinoconjunctivitis with or without associated mild asthma and sensitized to HDM. In addition,surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity. It will be recruited 50 patients susceptible to receive SCIT with HDM extract along 5 participating spanish sites. Primary endpoint of the study is to assess the safety and tolerability of subcutaneous immunotherapy in depot presentation and quick pattern in patients with rhinoconjunctivitis with or without mild asthma sensitized to house dust mites Secondary objective is to evaluate the indirect immunotherapy efficacy through the measurement of immunoglobulin level changes and cutaneous reactivity

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

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. Tear Film & Ocular Surface Society Dry Eye Workshop (TFOS DEWS) II recommends individualized management of DED based on the relative contribution of aqueous deficient and evaporative pathophysiology (to the extent that this can be determined), as well as disease severity. First-line for treating dry eye consists of over the counter (OTC) artificial tear drops, gels, ointments, or lubricants. Carboxymethyl cellulose (CMC) is one of the most common viscous polymers used in artificial tears to achieve prolonged residence time on the ocular surface. 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 "Ocular drops based upon carmellose" used as intended to relieve dry eye symptoms. 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 "Ocular drops based upon carmellose" according 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 (V0), one of the "Ocular drops based upon carmellose" products can be dispensed to the enrolled subject, depending on Investigator clinical evaluation and decision. 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. The first administration and the intervals at which the treatment should be repeated, to be done as per Investigator judgment and according the IFU, depend on various factors regarding the physiology of the patients (e.g. type of eye-tear film, anatomy, age), their lifestyle (e.g. use of computer, wearing of contact lenses) and their eye-surgery history (if applicable).

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.

The purpose of this 2-year study is to assess the sustained clinical efficacy and safety of 300 IR/day of a sublingual solution of birch pollen allergen extract starting 4 months prior to the birch pollen season and continuing over the birch pollen season compared with placebo for reduction of rhinoconjunctivitis-related symptoms and anti-allergy medication usage.

This is a study to evaluate the efficacy and safety of grass sublingual tablet (SCH 697243) versus placebo in the treatment of grass pollen-induced allergic hayfever symptoms. Participants will receive either the sublingual grass tablet or a placebo tablet during the study. It is expected that those participants receiving the active sublingual grass tablet will have less hayfever symptoms and need less medications to treat hayfever symptoms during the grass pollen season.