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.
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
- Recruiting
Clínica Sigma
Cali, Valle del Cauca Department, 760044
Jorge Satizabal Garcia, MD, 6026687575, jesati2000@yahoo.com
Andres Bustamante, MD, MSc, PhD
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.
Age
Years
Measured: At enrollment
Sex
Genre: male, female, other
Measured: At enrollment
Medical history
Presence or absence: Lupus, rheumatoid arthritis, scleroderma, Thyroid, none of above.
Measured: At enrollment
Occupation
employee, independent, unemployed, other
Measured: At enrollment
Secondary outcomes (5)
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
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
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
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
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.
- First posted8 Dec 2023
- Study start15 Mar 2023
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Tecnoquimicas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of the Ocular Surface With Preservative-Free Lubricants in Patients With Dry Eye
- ClinicalTrials.gov ID
- NCT06162442
- Acronym / sponsor ID
- CEI-001
- Conditions
- Dry Eye Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- TecnoquimicasIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Apr 2024 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preservative-free sterile ophthalmic solution, with 0.3% propylene glycol and 0.4% polyethylene glycol (400)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. | Drug | – |
Primary outcome
Age
Time frame: At enrollment
Years
Sex
Time frame: At enrollment
Genre: male, female, other
Medical history
Time frame: At enrollment
Presence or absence: Lupus, rheumatoid arthritis, scleroderma, Thyroid, none of above.
Occupation
Time frame: At enrollment
employee, independent, unemployed, other
5 secondary outcomes
Scores Dry Eye Questionnaire: DEQ-5
Time frame: At enrollment, first week, third month and sixth month
Scores Ocular Surface Disease Index Questionnaire: OSDI
Time frame: At enrollment, first week, third month and sixth month
National Eye Institute Visual Function Questionnaire de 25 ítems: NEI VFQ-25
Time frame: At enrollment, first week, third month and sixth month
Scores Questionnaires: Symptom Assessment In Dry Eye (SANDE)
Time frame: At enrollment, first week, third month and sixth month
Scores Questionnaires DED: Questionaries: Visual Analog Scale (VAS)
Time frame: At enrollment, first week, third month and sixth month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Derived from this study: PubMed 42251079Bustamante-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.