Dry Eye Syndromes Glaucoma
Conditions
Interventions
This is a randomized, controlled, two-arm clinical trial with 1:1 allocation, open-label design, including 60 participants with glaucoma using at least two topical hypotensive medications for more tha
Sponsors
Hospital de Clínicas da Universidade Estadual de Campinas
Hospital de Clínicas da Universidade Estadual de Campinas
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients over 18 years of age; volunteers from the Glaucoma sector of the Department of Ophthalmology at the State University of Campinas; diagnosis of Glaucoma in at least one eye; at least 6 months of use of two or more topical hypotensive medications; written provision of informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Patients with any other ocular surface disease, such as Sjögren’s Syndrome, or who have undergone refractive surgery; acute ocular diseases that affect the ocular surface, such as acute conjunctivitis; previous ophthalmologic trauma; previous ophthalmologic surgeries, except cataract surgery; use of contact lenses; patient refusal or failure to sign the Informed Consent Form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected improvement of dry eye symptoms measured by OSDI-6 score at 3, 6 and 12 months after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected improvement in clinical parameters related to ocular surface disease measured through tear break-up time, Schirmer test, fluorescein and lisamin green stainings, ocular hyperemia at 3, 6 and 12 months after treatment;It is expected improvement in objective parameters related to ocular surface disease measured by Keratography (non-invasive tear break-up time, tear meniscus height, meibography) at 3, 6 and 12 months after treatment;It is expected changes in the concentration of inflammatory mediators in tears (IL-1ß, IL-6, IL-10, IL-17, IFN-?, TNF-a, TGF-ß, MMP-9, TIMP-1) at 3, 6 and 12 months after treatment;It is expected improvement in the adherence to treatment measured by patient interview during the follow-up;It is expected changes in intraocular pressure measured by Goldmann tonometer in the follow-up visits;It is expected improvement in quality of life measured by a quality of life questionnaire modified from VFQ-25 | — |
Countries
BR
Contacts
Public ContactIsabela Valle
Universidade Estadual de Campinas
Outcome results
None listed