Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06162442
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-09-27
Brief Title:
Management of the Ocular Surface With Preservative-Free Lubricants in Patients With Dry Eye
Sponsor:
Tecnoquimicas
Organization:
Tecnoquimicas
Study Overview
Official Title:
Management of the Ocular Surface With Preservative-Free Lubricants in Patients With Dry Eye
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1Evaluate 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 SigmaProspective 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None