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

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.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: Preservative-free sterile ophthalmic solution, with 0.3% propylene glycol and 0.4% polyethylene glycol (400)

Detailed Description

Question Research: What are the clinical and epidemiological characteristics of patients with dry eye treated with preservative-free lubricating drops at Clínica Sigma? JUSTIFICATION The true importance of dry eye lies in the great impact that it is having today throughout the world, both in the visual quality and in the life of those who suffer from it. Preservative-free lubricating drops are part of the treatment to alleviate the symptoms of DED and their management is becoming more frequent and improves for the patient due to the fewer reports of adverse events in their use. Currently, in Colombia there is little scientific evidence. In particular, at the regional level, there is no characterization of DED, which allows determining its causes for a timely diagnosis and adequate treatment of the patient. From the Sigma Clinic, knowing the epidemiological characterization of the population that consults for symptoms of mild to moderate dry eye, will allow establishing risk factors and evaluating the evolution of the disease with clinical staining tests and knowing the visual quality of the patient with the use of questionnaires. GENERAL OBJECTIVE: To describe the clinical and epidemiological characteristics of patients with mild to moderate dry eye treated with preservative-free lubricating drops at the Sigma Clinic. SPECIFIC OBJECTIVES: 1.Evaluate through OSDI and DEQ questionnaires the clinical evolution of patients diagnosed with mild to moderate dry eye treated with preservative-free lubricants from Clínica Sigma. 2. Assess the frequency and severity of symptoms with the SANDE questionnaire in patients with moderate to dry eye treated with preservative-free lubricants from Clínica Sigma. 3. Assess the quality of life with the NEI VFQ-25 questionnaire in patients with moderate to dry eye treated with preservative-free lubricants from Clínica Sigma.Prospective cohort study in patients with a previous diagnosis of mild dry eye and moderate dry eye, classified by DEWS II scale.

Those who wish to participate in the study will be informed at the first ophthalmological care of the need to withdraw the medication they were using for the usual treatment and start a wash-out for seven days. After seven days, the patient will start with the Glicolub Ultra® lubricant with a dosage of 1 drop every 6 hours in both eyes and the following three visits will be made by the study ophthalmologist in their 1st week, 3rd month and 6omes, with Glicolub Ultra® preservative-free lubricating drops. The information obtained will be recorded in the case report formats, initial CRF-1 and follow-up CRF-2, designed for this study and within the clinical history of the participating subject. During each of these services, the participating subjects will fill out the five self-assessment questionnaires, on the OSDI, SANDE, DEQ-5, NEI VFQ-25 scales and a similar tolerability scale (see annexes). The completion will be done online (after training the platform) or by print with an estimated duration of 30 to 40 minutes.

In turn, the participant agrees to return the Glicolub Ultra® vials used during the study to the main investigator. Which, will allow to determine the adherence to the treatment after its weighing and verification of use.

• Study Type: Observational
• Enrollment (Estimated): 132

Contacts and Locations

• Study Contact: Name: Viviana Arce, MS; Phone Number: 114 +576026687575; Email: centroinvestigacion@clinicasigma.com.co

Study Locations

• Colombia
  • Valle Del Cauca
    • Cali, Valle Del Cauca, Colombia, 760044
      • Recruiting
      • Clínica Sigma
      • Contact: Jorge Satizabal Garcia, MD; Phone Number: 6026687575; Email: jesati2000@yahoo.com
      • Principal Investigator: Andres Bustamante, MD, MSc, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores Dry Eye Questionnaire: DEQ-5	5 questions, scale 0 to 22, with higher score, representing greater disability	At enrollment, first week, third month and sixth month
Scores Ocular Surface Disease Index Questionnaire: OSDI	Scale 0 to 100, with higher scores representing greater disability	At enrollment, first week, third month and sixth month
National Eye Institute Visual Function Questionnaire de 25 ítems: NEI VFQ-25	Scale 0 to 100, with 100 mm horizontal linear visual analog scale: 0 worse, to 100 is better	At enrollment, first week, third month and sixth month
Scores Questionnaires: Symptom Assessment In Dry Eye (SANDE)	Horizontal linear visual analog scale. With more mm, more ocular symptoms	At enrollment, first week, third month and sixth month
Scores Questionnaires DED: Questionaries: Visual Analog Scale (VAS)	Horizontal 0 to 100 mm linear visual analog scale. 0: worst and 100: better	At enrollment, first week, third month and sixth month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular pressure	Measurement in mmHg. Normal between 10 - 20 mmHg; > 21 mmHg is anormal	At enrollment, first week, third month and sixth month
Score ocular surface tests: TBUT	Tear breakup time: > 10 s, it is better, < 5 s, indicative of eye dry	At enrollment, first week, third month and sixth month
Score ocular surface tests: Schirmer test	Assess tear production: distance of tear in filter paper. < 5 mm dry eye, > 10 mm normal	At enrollment, first week, third month and sixth month

Collaborators and Investigators

• Sponsor: Tecnoquimicas

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Estimated): December 15, 2023
• Study Completion (Estimated): April 15, 2024

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Estimated): December 8, 2023

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: CEI-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No