Management of the Ocular Surface With Preservative-Free Lubricants in Patients With Dry Eye

NCT06162442 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 132

Last updated 2023-12-08

No results posted yet for this study

Summary

Observational and prospective cohort study that seek to evaluate the epidemiological characteristics and changes in the ocular surface of patients diagnosed with dry eye disease who are treated with preservative-free lubricating drops.

Conditions

Interventions

DRUG

Preservative-free sterile ophthalmic solution, with 0.3% propylene glycol and 0.4% polyethylene glycol (400)

The procedures during the study consist of ophthalmological activities and attention to the participating subject with a diagnosis of DED and who starts using a specified ocular lubricant, free of preservatives. The ophthalmologist will notify the subject of the "wash out", which will consist of suspending the usual treatment medication for 7 days, to then start with the lubricant Glicolub Ultra®, with a dosage of 1 drop every 6 hours in both eyes. Self-assessment questionnaires will be delivered for their respective completion. An assessment will be made by the comprehensive ophthalmologist in all clinical tests for dry eye with a mild to moderate diagnosis, under compliance with the TOSF DEWS II criteria and study inclusion criteria.

Sponsors & Collaborators

  • Tecnoquimicas

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2023-12-15
Completion
2024-04-15

Countries

  • Colombia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06162442 on ClinicalTrials.gov