Evaluating preservative-free lubricants for dry eye management
Management of the Ocular Surface With Preservative-Free Lubricants in Patients With Dry Eye
This study is trying to see how well preservative-free eye drops help people with mild to moderate dry eye and what factors might affect their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 132 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Tecnoquimicas Industry-sponsored |
| Locations | 1 site (Cali, Valle Del Cauca) |
| Trial ID | NCT06162442 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to assess the clinical and epidemiological characteristics of patients with mild to moderate dry eye disease who are treated with preservative-free lubricating drops at Clínica Sigma in Colombia. The study will gather data on the evolution of the disease through clinical staining tests and patient-reported outcomes using questionnaires. By characterizing this population, the study seeks to identify risk factors and improve treatment approaches for dry eye disease, which significantly impacts patients' visual quality and quality of life.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with mild to moderate dry eye disease who are currently using preservative-free lubricating drops.
Not a fit: Patients with severe dry eye, significant ocular surface anomalies, or those undergoing treatments that may affect the ocular surface are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding and management of dry eye disease, leading to improved patient outcomes.
How similar studies have performed: While there is limited scientific evidence in Colombia regarding dry eye disease management, similar studies in other regions have shown positive outcomes with preservative-free lubricants.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to sign informed consent. * Any sex. * Women of reproductive age should secure a method during the contraceptive study. * Diagnosis of dry eye (mild, moderate) prior to the study in treatment with lubricants with preservatives. Exclusion Criteria: * Patients with any acquired or congenital anomaly or ocular malformation that prevents an adequate exploration of the ocular surface. * Patients with a history of ocular surface surgery (cornea and conjunctiva). * Patients being treated with medications that may compromise the state of the ocular surface: glaucoma, allergy, scarring diseases. * Patients with allergy to fluorescein, lissamine green or tetracaine. * Patients with lacrimal duct obstruction * Severe dry eye * Kidney failure * Liver failure * Pregnancy * Breastfeeding
Where this trial is running
Cali, Valle Del Cauca
- Clínica Sigma — Cali, Valle Del Cauca, Colombia (Recruiting)
Study contacts
- Study coordinator: Viviana Arce, MS
- Email: centroinvestigacion@clinicasigma.com.co
- Phone: +576026687575
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.