Dry eye syndromes
Conditions
Interventions
Prospective, multicenter, single-arm, interventional study evaluating the use of ocular lubricant based on phospholipid nano-emulsion (registered principle, using the commercial formulation of the dru
Visit 2 – baseline, first day of treatment
Visit 3 – day 14 and Visit 4 – day 28. The screening visit serves to assess the patients eligibility for the study. The baseline visit to carry out exams immediately before treatment. Visits 3 and 4 a
Sponsors
Cetos, Pesquisa Diagnóstico e Tratamento Oftalmológico LTDA
Cetos, Pesquisa Diagnóstico e Tratamento Oftalmológico LTDA
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants 18 years of age or older of both sexes; Ability to understand and analyze the free and informed consent form; Able and willing to attend all study visits; Present a TFBUT bigger than 5 seconds in at least one eye; Dry eye symptoms with Ocular Surface Disease Index questionnaire bigger than 13 points; Present at least one of the 3 criteria below in at least one of the eyes: Schirmer test score I less than 9 mm; Meibomian transparency quality score bigger than 1 (on a scale of 0 to 3) or meibomian gland expressibility score bigger than 1 (on a scale of 0 to 3); Patients who completed the competitions mentioned in the first 2 items; Best corrected visual acuity bigger than 20/80 in both eyes; Have mild to moderate dry eye; Be willing to discontinue use of all artificial tear supplements and only use the study product as directed throughout the entire duration of the study
Exclusion criteria
Exclusion criteria: Patients who meet any of the criteria listed below during the screening visit will be excluded from participation in this study: History of hypersensitivity to the study drug or any component related to the study product; Use of any topical ocular medication preserved with benzalkonium chloride or other product known to be toxic to the tear lipid layer one month prior to the study screening visit; Start of eye hygiene 4 weeks before the screening visit; History of malignancy in any organ treated or not within an interval of less than 5 years; Eye abnormalities that may compromise the safety and effectiveness of treatment, such as: Eyelid abnormalities that compromise blinking and complete eyelid closure; Corneal diseases such as ulcers, abrasions, keratoconus or dystrophies, which may be active or affect vision; Metaplasia of the ocular surface; history of recurrent corneal erosion; evidence of corneal neovascularization; history of herpes simplex keratitis or zoster; uncontrolled systemic disease; eye infection; participation in any clinical study less than 30 days prior to the screening visit; tear punctum plug insertion or any procedure 30 days prior to the screening visit; initiation of use or change in dose of systemic medications (antihistamines, anti-depressants, anti-psychotics and benzodiazepines) that may cause dry eye 30 days before the screening visit; use of contact lenses within one week of the screening visit; history of ocular surgeries within 6 months prior to the screening visit; start of any topical ocular medications 2 weeks prior to treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the results of the treatment of patients with dry eye due to aqueous, mixed or evaporative deficiency after using Systane Complete with a reduced frequency of 2 times a day. This assessment wil be carried out by questioning Ocular Surface Disease Index symptoms after 14 days and 28 days of using Systane Complete in patients with dry eye.It is expected that administration reduced to twice a day will be beneficial in improving the symptoms of dry eye subtypes. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected | — |
Countries
Brazil
Contacts
Public ContactMonica Alves
Universidade Estadual de Campinas - UNICAMP
Outcome results
None listed