Clinical trial NCT06162442: Management of the Ocular Surface With Preservative-Free Lubricants in Patients With Dry Eye
Official title: Management of the Ocular Surface With Preservative-Free Lubricants in Patients With Dry Eye
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dry Eye Disease
Lead sponsor: Tecnoquimicas
Sponsor class: INDUSTRY
First posted: 2023-12-08
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Age
timeFrame: At enrollment
measure: Sex
timeFrame: At enrollment
measure: Medical history
timeFrame: At enrollment
measure: Occupation
timeFrame: At enrollment
Secondary outcomes:
measure: Scores Dry Eye Questionnaire: DEQ-5
timeFrame: At enrollment, first week, third month and sixth month
measure: Scores Ocular Surface Disease Index Questionnaire: OSDI
timeFrame: At enrollment, first week, third month and sixth month
measure: National Eye Institute Visual Function Questionnaire de 25 ítems: NEI VFQ-25
timeFrame: At enrollment, first week, third month and sixth month
measure: Scores Questionnaires: Symptom Assessment In Dry Eye (SANDE)
timeFrame: At enrollment, first week, third month and sixth month
measure: Scores Questionnaires DED: Questionaries: Visual Analog Scale (VAS)
timeFrame: At enrollment, first week, third month and sixth month
Other outcomes:
measure: Ocular pressure
timeFrame: At enrollment, first week, third month and sixth month
measure: Score ocular surface tests: TBUT
timeFrame: At enrollment, first week, third month and sixth month
measure: Score ocular surface tests: Schirmer test
timeFrame: At enrollment, first week, third month and sixth month
Locations:
city: Cali
country: Colombia
facility: Clínica Sigma
state: Valle Del Cauca
Study officials:
References: