An observational study in Dry Eye Disease, sponsored by Tecnoquimicas. Recruiting at 1 site in Colombia. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-08.
Sponsored by Tecnoquimicas · Observational
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.
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.
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This study's planned enrollment of 132 is above the median of 90 across 171 observational studies indexed under Dry Eye Syndromes.
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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.
Exclusion Criteria:
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.
Age
Years
Time frame: At enrollment
Sex
Genre: male, female, other
Time frame: At enrollment
Medical history
Presence or absence: Lupus, rheumatoid arthritis, scleroderma, Thyroid, none of above.
Time frame: At enrollment
Occupation
employee, independent, unemployed, other
Time frame: At enrollment
Scores Dry Eye Questionnaire: DEQ-5
5 questions, scale 0 to 22, with higher score, representing greater disability
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At enrollment, first week, third month and sixth month
Ocular pressure
Measurement in mmHg. Normal between 10 - 20 mmHg; \> 21 mmHg is anormal
Time frame: 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
Time frame: 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
Time frame: At enrollment, first week, third month and sixth month
Plan to share: No
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