Active clinical trials for "Dry Eye Syndromes"

This is a Phase 2/3 study to evaluate the safety and efficacy of 2 different dose concentrations of OTX-101 dosed twice a day in both eyes for 84 days compared to placebo (vehicle) in patients with keratoconjunctivitis sicca (dry eye disease).

This study evaluates the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally (active) compared with the same device applied extranasally (control) relating to symptoms of dry eye exacerbated by the Controlled Adverse Environment model.

The objective of this exploratory study is to determine the safety and efficacy of 0.002% Naltrexone Ophthalmic Solution, compared to placebo for the treatment of the signs and symptoms of dry eye in diabetic subjects.

The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and effective compared to placebo for the treatment of the signs and symptoms of dry eye syndrome.

This is a phase 2, multicenter, double-blind, placebo control, randomized study to evaluate the efficacy and safety of orally administered SA001 compared to placebo in patients with Dry Eye Syndrome. The clinical trial consists of a wash-out period of 14 days, a treatment period of 12 weeks, and a follow-up period of 1 week after administration of the Investigational Product. If the subject voluntarily signs the informed consent form(ICF), the investigator conducts screening tests and check medical history to evaluate the subject's suitability. As a result of the screening test, eligible subjects should stop using the prior medication for dry eye syndrome during the 14 days of observation period, and if necessary, subjects can use rescue drug(artificial tears) for the first 11 days, and then discontinue all eye drops including rescue drug(artificial tears) for 3 days. And all of these subjects will be randomized in a 1:1:1:1 ratio to receive 3 different doses of investigational product (SA001 or placebo) everyday for 12 weeks. During the treatment period, If necessary, subjects can use the rescue drug (artificial tears), and the number of administration of rescue drug is limited to 3 times a day, and when used, the administration time should be recorded in the subject's diary. Subjects should visit to the study site on 2, 4, 8 and 12 weeks after starting dosing investigational product. Efficacy evaluation results are collected from both eyes, and the primary evaluation variable is analyzed using the test results collected from 'Worse eye' (the eye with the worse keratoconjunctival staining result among both eyes). Worse eye will be determined at the baseline visit and, if the results of both eyes are the same, the test result of the left eye is used.

The objectives of this trial are to evaluate the safety and tolerability of perfluorohexyloctane (NOV03) ophthalmic solution during long-term use in subjects with Dry Eye Disease (DED) associated with MGD (Meibomian Gland Dysfunction). Further objective is to evaluate the efficacy of perfluorohexyloctane (NOV03) solution during long-term use in subjects with DED associated with MGD.

Study design: Phase I-II clinical trial, comparative, non-inferiority with active control, parallel groups, double blind with randomisation. Safety analysis when completing the visits of the first 12 subjects of the Nanodrop® group, if there are less than 20% of unexpected Events (EA), related to the research product, recruitment is continued until the sample is completed for efficacy analysis objectives Security: Evaluate the safety of the ophthalmic application of Nanodrop® by quantifying the incidence of unexpected Adverse Events (EA) related to the research product (PI). Effectiveness: Demonstrate the non-inferiority of Nanodrop® compared to Systane® Balance, in the efficacy of the treatment of patients with dry eye, by means of the Ocular Surface Disease Index (OSDI). Hypothesis Security: H0 = Nanodrop® is safe in its ophthalmic application as it presents an incidence of unexpected adverse events related to the research drug, less than 20% of the population of Nanodrop® safety group. H1 = Nanodrop® is not safe in its ophthalmic application, as it presents an incidence of unexpected adverse events related to the research drug, exceeding 20% of the population of Nanodrop® safety group. Effectiveness: H0 = Nanodrop® is lower than Systane® Balance by more than 5 points in the OSDI test score. H1 = Nanodrop® is lower than Systane® Balance by 5 points or less in the OSDI test score. Number of subjects: n = 126 evaluable subjects 63 evaluable subjects per group (both eyes). Main inclusion criteria: Dry eye diagnosis Duration of intervention treatment: 28 days Approximate duration of the subject in the study: 35 days

Two-period, controlled, randomized and open clinical trial. The sample was composed of adult women with moderate to severe hypo secretory dry eye associated with Sjögren's syndrome, who attended the ocular surface office, derived from the general ophthalmology clinic, from the Rheumatology or Immunology department. The three interventions were randomized: autologous serum (GSA), Rebamipida 2% (GR) and a combined treatment (GSAR). The following were used as outcome measures: OSDI self-administered questionnaire (Ocular Surface Disease Index), tear-rupture time (BUT), fluorescein staining, Bengal Rose staining and Schirmer's test without anesthesia to assess the answer to each treatment

Today, cataract surgery has become one of the safest and most effective eye surgical procedures performed on many people through the development and development of surgical techniques and instruments. However, a significant number of patients who underwent cataract surgery still complain about postoperative symptoms, such as irritation, pain, dryness, burning sensation, and foreign body sensation. The reasons of dry eye (DE) development after cataract surgery include thermal and light toxicity from the microscope, corneal epithelial damage, and frequent irrigation of ocular surface during operation, sterilization of conjunctival sac and eyelid with chemicals, transection of the corneal nerves by corneal incision, use of topical anesthetics, and preservatives in topical eye drops. In this era of high expectation of patients and premium intraocular lenses, the postoperative discomforts cannot be accepted to many patients. Several studies have recently reported that the common cause of postoperative symptoms of the patients is DE. Furthermore, if the ocular surface is deformed due to DE syndrome after surgery, the optical quality is greatly affected which results in a decrease of the quality of vision. If the tear film becomes irregular, the higher-order aberration can change due to local irregular total radius of curvature of ocular surface and result in decreased visual acuity. There have been many attempts to treat DE syndrome after cataract surgery. Artificial tears are commonly used for the first line treatment of postoperative DE and several studies revealed its effectiveness on management of DE symptoms and signs. The postoperative use of cyclosporine 0.05 % topical eye drop improved DE symptoms and visual quality after cataract surgery. Recently, diquafosol sodium ophthalmic solution has been used for the management of DE after cataract. Diquafosol is a dinucleotide derivative and functions as agonist to the purinergic P2Y2 receptor. Diquafosol is known to stimulate not only the mucin secretion from the goblet cells but also water secretion from conjunctival epithelial cells and accessory lacrimal glands. According to previous studies, diquafosol has been found to be very effective in treating DE after cataract and to alleviate symptoms of DE syndrome. Furthermore, several studies have shown that topical diquafosol has a better efficacy in managing DE after cataract surgery than artificial tears. The preservative free diquafosol ophthalmic solution has been released recently. The use of eye drops without preservatives has also been shown to play an important role in the treatment of DE after cataract surgery. Until now, there is no study that evaluated the effect of preservative free diquafosol ophthalmic solution. Thus the investigators try to investigate the efficacy of preservative free diquafosol ophthalmic solution compared to preservative containing diquafosol ophthalmic solution and sodium hyaluronate ophthalmic solution, which are widely used in patients with DE after cataract surgery.

Evaluate the tolerability, efficacy and safety of VOS versus Restasis® in subjects with mild to moderate Dry Eye Disease (DED).