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Dry Eye DiseaseNCT06162442

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

An observational study of Dry Eye Disease, run by Tecnoquimicas at 1 site in Colombia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Dry Eye Disease
What is being tested?
Preservative-free sterile ophthalmic solution, with 0.3% propylene glycol and 0.4% polyethylene glycol (400)
How many people
132 participants
Where
1 siteColombia
Study dates
15 Mar 2023to 15 Apr 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • Kidney failure
  • Liver failure
  • Pregnancy
  • Breastfeeding

Trial locations and contacts

1 site in 1 country.

Colombia1 site, 1 recruiting
  • Clínica Sigma

    Cali, Valle del Cauca Department, 760044

    Jorge Satizabal Garcia, MD, 6026687575, jesati2000@yahoo.com

    Andres Bustamante, MD, MSc, PhD

    Recruiting

Other trials in Colombia

About this study

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.

Read the 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.

Conditions
Dry Eye Disease
Being tested
Preservative-free sterile ophthalmic solution, with 0.3% propylene glycol and 0.4% polyethylene glycol (400)
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Age

    Years

    Measured: At enrollment

  2. Sex

    Genre: male, female, other

    Measured: At enrollment

  3. Medical history

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

    Measured: At enrollment

  4. Occupation

    employee, independent, unemployed, other

    Measured: At enrollment

Secondary outcomes (5)
  1. Scores Dry Eye Questionnaire: DEQ-5

    5 questions, scale 0 to 22, with higher score, representing greater disability

    Measured: At enrollment, first week, third month and sixth month

  2. Scores Ocular Surface Disease Index Questionnaire: OSDI

    Scale 0 to 100, with higher scores representing greater disability

    Measured: At enrollment, first week, third month and sixth month

  3. 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

    Measured: At enrollment, first week, third month and sixth month

  4. Scores Questionnaires: Symptom Assessment In Dry Eye (SANDE)

    Horizontal linear visual analog scale. With more mm, more ocular symptoms

    Measured: At enrollment, first week, third month and sixth month

  5. Scores Questionnaires DED: Questionaries: Visual Analog Scale (VAS)

    Horizontal 0 to 100 mm linear visual analog scale. 0: worst and 100: better

    Measured: At enrollment, first week, third month and sixth month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2023
  2. Study start15 Mar 2023
  3. Primary completion15 Dec 2023 (estimated)
  4. Study completion15 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06162442
Sponsor's protocol ID
CEI-001
Status last verified
Nov 2023
First submitted
27 Sep 2023
Last updated
8 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bustamante-Arias A, Satizabal-Garcia JE, Pino-Murcia D, Cifuentes-Gonzalez C. ENRICHED trial of preservative-free lubricants in dry eye disease. Sci Rep. 2026 Jun 6;16(1):23626. doi: 10.1038/s41598-026-50779-6.

    PubMed 42251079

Questions about this trial

What is this clinical trial studying?

An observational study of Dry Eye Disease, run by Tecnoquimicas at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Viviana Arce, MS (+576026687575 ext. 114, centroinvestigacion@clinicasigma.com.co), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Age (time frame: At enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06162442, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.

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