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

NCT06162442 | Unknown

• 1 other identifier: CEI-001
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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

Dry Eye Disease

Outcome Measures

Primary Outcomes (4)

• Age

  Years

  At enrollment

• Sex

  Genre: male, female, other

  At enrollment

• Medical history

  Presence or absence: Lupus, rheumatoid arthritis, scleroderma, Thyroid, none of above.

  At enrollment

• Occupation

  employee, independent, unemployed, other

  At enrollment

Secondary Outcomes (5)

• Scores Dry Eye Questionnaire: DEQ-5

  At enrollment, first week, third month and sixth month

• Scores Ocular Surface Disease Index Questionnaire: OSDI

  At enrollment, first week, third month and sixth month

• National Eye Institute Visual Function Questionnaire de 25 ítems: NEI VFQ-25

  At enrollment, first week, third month and sixth month

• Scores Questionnaires: Symptom Assessment In Dry Eye (SANDE)

  At enrollment, first week, third month and sixth month

• Scores Questionnaires DED: Questionaries: Visual Analog Scale (VAS)

  At enrollment, first week, third month and sixth month

Other Outcomes (3)

• Ocular pressure

  At enrollment, first week, third month and sixth month

• Score ocular surface tests: TBUT

  At enrollment, first week, third month and sixth month

• Score ocular surface tests: Schirmer test

  At enrollment, first week, third month and sixth month

Interventions

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

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a previous diagnosis of mild to moderate dry eye from the dry eye unit of the Sigma Clinic, under the DEWS II criteria, being treated with lubricants with preservatives. Those who wish to participate in the study must have the drug with preservatives removed by washing or "wash out" for seven days and meet the inclusion and exclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tecnoquimicas: lead

Study Sites (1)

Clínica Sigma

Cali, Valle del Cauca Department, 760044, Colombia

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Propylene Glycol; Polyethylene Glycols

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Propylene Glycols; Glycols; Alcohols; Organic Chemicals; Ethylene Glycols; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Viviana Arce, MS

CONTACT

+576026687575; centroinvestigacion@clinicasigma.com.co

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: December 8, 2023
• Study Start: March 15, 2023
• Primary Completion: December 15, 2023
• Study Completion: April 15, 2024
• Last Updated: December 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)