Dry Eye Disease
Conditions
Brief summary
Efficacy: - Subjective evolution of patients' symptomatology using the OSDI questionnaire at 12 weeks. - Change in ocular surface staining at 12 weeks using the Oxford scale., Safety: • Global tolerance assessed by the investigator at 2 and 12 weeks. • Patient-assessed global tolerance at 2 and 12 weeks. • Adverse events mentioned throughout the study, both ocular and systemic. • Ocular adverse events (AEs). • - Systemic adverse events (AEs)
Detailed description
Demographic variables - Patient code - Age - Sex - Toxic habits (smoking, alcohol), Clinical variables - Diagnosed with Sjögren's disease (primary or secondary) - Diagnosed with Rosacea - Personal and ophthalmologic history - Previous medication, Efficacy: - Subjective evolution of patients' symptomatology using the OSDI questionnaire at 2 weeks. - Change in ocular surface staining at 2 weeks using the Oxford scale. - Change in global pathology symptoms with respect to severity and frequency at 2 and 12 weeks using the Visual Analog Scale (VAS). - Change in best corrected visual acuity (LogMAR VA) at 2 and 12 weeks., Efficacy: - Change in tear quantity at 2 and 12 weeks using Schirmer's test. - Change in time to tear film breakage (TBUT) at 2 and 12 weeks. - Intraocular pressure (IOP) at 2 and 12 weeks.
Interventions
Sponsors
Biotechnology Institue I Mas D S.L.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: - Subjective evolution of patients' symptomatology using the OSDI questionnaire at 12 weeks. - Change in ocular surface staining at 12 weeks using the Oxford scale., Safety: • Global tolerance assessed by the investigator at 2 and 12 weeks. • Patient-assessed global tolerance at 2 and 12 weeks. • Adverse events mentioned throughout the study, both ocular and systemic. • Ocular adverse events (AEs). • - Systemic adverse events (AEs) | — |
Secondary
| Measure | Time frame |
|---|---|
| Demographic variables - Patient code - Age - Sex - Toxic habits (smoking, alcohol), Clinical variables - Diagnosed with Sjögren's disease (primary or secondary) - Diagnosed with Rosacea - Personal and ophthalmologic history - Previous medication, Efficacy: - Subjective evolution of patients' symptomatology using the OSDI questionnaire at 2 weeks. - Change in ocular surface staining at 2 weeks using the Oxford scale. - Change in global pathology symptoms with respect to severity and frequency at 2 and 12 weeks using the Visual Analog Scale (VAS). - Change in best corrected visual acuity (LogMAR VA) at 2 and 12 weeks., Efficacy: - Change in tear quantity at 2 and 12 weeks using Schirmer's test. - Change in time to tear film breakage (TBUT) at 2 and 12 weeks. - Intraocular pressure (IOP) at 2 and 12 weeks. | — |
Countries
Spain
Outcome results
None listed