Dry Eye SyndromesNCT05778942
Investigation of Preservative-Free Ophthalmic Solution in Ocular Dryness
An observational study of Dry Eye Syndromes, run by SIFI SpA at 4 sites in Spain.
Trial summary
This is a multicenter, prospective, observational, open-label, non-interventional study evaluating the clinical performance and the safety of 4 daily instillations of the ophthalmic solution in the treatment of eye discomfort, in particular due to eye dryness Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Eyestil SYNFO
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 4 sitesSpain
- Study dates
- 23 Feb 2023to 19 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female subjects with signs and symptoms of ocular discomfort resulting from ocular dryness.
Who may be able to join
- Male or female subjects aged 18 years or older
- Subject able to provide Informed Consent, in compliance with Good Clinical Practice and local laws (thus, subject able to comprehend the full nature and purpose of the study, including possible risks and side effects)
- Subjects with ocular discomfort resulting from eye dryness in one or both eyes as determined by:
- Scoring of ocular surface staining with fluorescein using the NEI scale (summing the score of cornea and conjunctiva, the total score per single eye range should be at least ≥6 on the 0-33 NEI scale)
- TFBUT with fluorescein ≤10 seconds. The TFBUT value will be recorded as the average of 3 measurements
- SANDE questionnaire ≥35
- Subject able to comply with the requirements of the clinical investigation plan, according to the Investigator
Who cannot join
- Corneal injuries or abrasions of traumatic origin
- Ocular infection or clinically significant inflammation (such as Herpes Simplex infection, corneal virus infection, bacterial, viral or fungal conjunctivitis, tuberculosis and mycosis of the eye, purulent and herpetic blepharitis, stye)
- Sjögren's syndrome
- Stevens-Johnson syndrome
- Concomitant treatment with drugs that may interfere with tear gland secretion
- Patients using any topical therapies such as non-steroidal anti-inflammatory drugs, cortisone, cyclosporine, vasoconstrictor, artificial tears (different than the investigated product)
Show all 11Show fewer
- Treatment with topical or systemic corticosteroids in the 4 weeks preceding the study
- Known or potential hypersensitivity and/or history of allergic reactions to one of the components of the topical medical device
- Participation in another clinical trial within the previous 30 days
- Evidence of severe or uncontrolled systemic disease or any other significant disorders, which in the opinion of the Investigator does not allow the participation in the study or could compromise the results
- Pathologies associated with corneal thinning
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Oftalvist
Alicante, 03001
Hospital Arruzafa
Córdoba, 14012
Hospital Clínico San Carlos
Madrid, 28040
Hospital Nuestra Señora de Gracia
Zaragoza, 50004
About this study
Official title: Multicentric Clinical Investigation on the Use of Preservative-Free Ophthalmic Solution Based on Sodium Hyaluronate and Xanthan Gum in the Treatment of Eye Discomfort, in Particular in Case of Ocular Dryness
This is a multicenter, prospective, observational, open-label, non-interventional study evaluating the clinical performance and the safety of 4 daily instillations of the ophthalmic solution in the treatment of eye discomfort, in particular due to eye dryness
Read the detailed description
Primary objective
▪ To evaluate the clinical performance of Eyestil SYNFO® as detected by the reduction of keratitis lesions objectified by corneal and conjunctival staining tests with fluorescein using the National Eye Institute (NEI) scale after 1 month of treatment compared to baseline.
Secondary objectives
- To evaluate the mean change of the corneal and conjunctival staining score with fluorescein using the NEI scale after 14 days of treatment and after 3 months of treatment compared to baseline.
- To evaluate conjunctival hyperemia index assessed by OCULUS Keratograph after 14 days, 1 month and 3 months of treatment compared to baseline.
- To evaluate the tear film stability as objectified by the tear film break-up time (TFBUT) test after 14 days, 1 month and 3 months of study treatment initiation compared to baseline.
- To evaluate the changes on the Best Corrected Visual Acuity (BCVA) measured by the "Early Treatment Diabetic Retinopathy Study" (ETDRS) after 14 days, 1 month and 3 months of study treatment initiation compared to baseline.
- To compare patients reported outcomes with baseline, using specifically:
- the patient's reported Symptom Assessment questionnaire iN Dry Eye (SANDE) after 1 and 3 months of treatment;
- the patient's Dry Eye-Related Quality-of-Life Score (DEQS) questionnaire after 1 and 3 months of treatment.
- To evaluate the safety and compliance of the medical device throughout the entire study period.
- Conditions
- Dry Eye Syndromes
- Being tested
- Eyestil SYNFO
- Keywords
- Dry eye
- 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.
Eyestil SYNFODevice
Instillation of study drug in both eyes: preservative-free ophthalmic solution based on sodium hyaluronate and xanthan gum
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Single arm with commercial study drug: Eyestil SYNFO Receives: Device: Eyestil SYNFO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratitis lesions
To evaluate the clinical performance of Eyestil SYNFO® as detected by the reduction of keratitis lesions objectified by corneal and conjunctival staining tests with fluorescein using the National Eye Institute (NEI) scale after 1 month of treatment compared to baseline.
Measured: 1 month
Secondary outcomes (10)
Keratitis Lesions
To evaluate the mean change of the corneal and conjunctival staining score with fluorescein using the National Eye Institute scale compared to baseline.
Measured: Day 14 and at 3 months
Conjuctival Hyperemia
To evaluate conjunctival hyperemia index by OCULUS keratograph
Measured: Day 14, 1 month and 3 months
Best Corrected Visual Acuity
To evaluate changes in Best Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score.
Measured: Day 14, 1 month and 3 months
Tear Film Stability Break-Up time
The conjunctival tear film stability break-up time (TFBUT) will be evaluated after the instillation of 5 µl of a 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac- of each eye. The TFBUT value will be the average of 3 measurements.
Measured: Day 14, 1 month and 3 months
SANDE Questionnaire
To compare patients reported outcomes with baseline, using the Symptom Assessment questionnaire iN Dry Eye (SANDE) questionnaire
Measured: 1 and 3 months
DEQS Questionnaire
To compare patients reported outcomes with baseline, using the Dry Eye-Related Quality-of-Life Score (DEQS) questionnaire
Measured: 1 and 3 months
Number of Adverse Events
To evaluate the safety through general assessment of adverse events
Measured: From date of randomization up to 3 months
Investigator Global Assessment Score
To evaluate the safety using the Investigator Global Assessment Score
Measured: From date of randomization up to 3 months
Intra Ocular Pressure
To evaluate the safety using the measurement of the intraocular pressure
Measured: From date of randomization up to 3 months
Number and status (empty/unused) of returned devices
To evaluate compliance based on treatment administration and returned medical devices
Measured: Day 14, 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start23 Feb 2023
- Primary completion6 Nov 2023
- Study completion19 Dec 2023
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 SyndromesStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- SIFI SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claudine Civiale, Study director, SIFI S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778942
- Sponsor's protocol ID
- 053/SI SYNFO
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Molero Senosiain M, Burgos-Blasco B, Perez-Garcia P, Sanchez-Ventosa A, Villalba-Gonzalez M, Lopez Perez MD, Diaz JC, Diaz-Mesa V, Villarrubia Cuadrado A, Artiaga Elordi E, Larrosa Poves JM, Blasco A, Mateo A, Civiale C, Bonino L, Cano-Ortiz A. Performance and Safety of a Sodium Hyaluronate, Xanthan Gum, and Osmoprotectants Ophthalmic Solution in the Treatment of Dry Eye Disease: An Observational Clinical Investigation. Ophthalmol Ther. 2025 Apr;14(4):675-692. doi: 10.1007/s40123-025-01099-x. Epub 2025 Feb 21.
PubMed 39984804
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Clinical Investigation on the Use of Preservative-Free Ophthalmic Solution Based on Sodium Hyaluronate and Xanthan Gum in the Treatment of Eye Discomfort, in Particular in Case of Ocular Dryness
- ClinicalTrials.gov ID
- NCT05778942
- Acronym / sponsor ID
- 053/SI SYNFO
- Conditions
- Dry Eye Syndromes
- Keywords
- Dry eye
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- SIFI SpAIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 6 Nov 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 22 Mar 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.
This is a multicenter, prospective, observational, open-label, non-interventional study evaluating the clinical performance and the safety of 4 daily instillations of the ophthalmic solution in the treatment of eye discomfort, in particular due to eye dryness
Detailed description
Primary objective
▪ To evaluate the clinical performance of Eyestil SYNFO® as detected by the reduction of keratitis lesions objectified by corneal and conjunctival staining tests with fluorescein using the National Eye Institute (NEI) scale after 1 month of treatment compared to baseline.
Secondary objectives
- To evaluate the mean change of the corneal and conjunctival staining score with fluorescein using the NEI scale after 14 days of treatment and after 3 months of treatment compared to baseline.
- To evaluate conjunctival hyperemia index assessed by OCULUS Keratograph after 14 days, 1 month and 3 months of treatment compared to baseline.
- To evaluate the tear film stability as objectified by the tear film break-up time (TFBUT) test after 14 days, 1 month and 3 months of study treatment initiation compared to baseline.
- To evaluate the changes on the Best Corrected Visual Acuity (BCVA) measured by the "Early Treatment Diabetic Retinopathy Study" (ETDRS) after 14 days, 1 month and 3 months of study treatment initiation compared to baseline.
- To compare patients reported outcomes with baseline, using specifically:
- the patient's reported Symptom Assessment questionnaire iN Dry Eye (SANDE) after 1 and 3 months of treatment;
- the patient's Dry Eye-Related Quality-of-Life Score (DEQS) questionnaire after 1 and 3 months of treatment.
- To evaluate the safety and compliance of the medical device throughout the entire study period.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | – | Device: Eyestil SYNFOSingle arm with commercial study drug: Eyestil SYNFO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects with signs and symptoms of ocular discomfort resulting from ocular dryness.
Key inclusion criteria (7 listed)
- Male or female subjects aged 18 years or older
- Subject able to provide Informed Consent, in compliance with Good Clinical Practice and local laws (thus, subject able to comprehend the full nature and purpose of the study, including possible risks and side effects)
- Subjects with ocular discomfort resulting from eye dryness in one or both eyes as determined by:
- Subject able to comply with the requirements of the clinical investigation plan, according to the Investigator
Key exclusion criteria (11 listed)
- Corneal injuries or abrasions of traumatic origin
- Ocular infection or clinically significant inflammation (such as Herpes Simplex infection, corneal virus infection, bacterial, viral or fungal conjunctivitis, tuberculosis and mycosis of the eye, purulent and herpetic blepharitis, stye)
- Sjögren's syndrome
- Stevens-Johnson syndrome
- Concomitant treatment with drugs that may interfere with tear gland secretion
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 |
|---|---|---|
| Eyestil SYNFOInstillation of study drug in both eyes: preservative-free ophthalmic solution based on sodium hyaluronate and xanthan gum | Device | Single Arm |
Primary outcome
Keratitis lesions
Time frame: 1 month
To evaluate the clinical performance of Eyestil SYNFO® as detected by the reduction of keratitis lesions objectified by corneal and conjunctival staining tests with fluorescein using the National Eye Institute (NEI) scale after 1 month of treatment compared to baseline.
10 secondary outcomes
Keratitis Lesions
Time frame: Day 14 and at 3 months
Conjuctival Hyperemia
Time frame: Day 14, 1 month and 3 months
Best Corrected Visual Acuity
Time frame: Day 14, 1 month and 3 months
Tear Film Stability Break-Up time
Time frame: Day 14, 1 month and 3 months
SANDE Questionnaire
Time frame: 1 and 3 months
DEQS Questionnaire
Time frame: 1 and 3 months
Number of Adverse Events
Time frame: From date of randomization up to 3 months
Investigator Global Assessment Score
Time frame: From date of randomization up to 3 months
Intra Ocular Pressure
Time frame: From date of randomization up to 3 months
Number and status (empty/unused) of returned devices
Time frame: Day 14, 1 month and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Derived from this study: PubMed 39984804Molero Senosiain M, Burgos-Blasco B, Perez-Garcia P, Sanchez-Ventosa A, Villalba-Gonzalez M, Lopez Perez MD, Diaz JC, Diaz-Mesa V, Villarrubia Cuadrado A, Artiaga Elordi E, Larrosa Poves JM, Blasco A, Mateo A, Civiale C, Bonino L, Cano-Ortiz A. Performance and Safety of a Sodium Hyaluronate, Xanthan Gum, and Osmoprotectants Ophthalmic Solution in the Treatment of Dry Eye Disease: An Observational Clinical Investigation. Ophthalmol Ther. 2025 Apr;14(4):675-692. doi: 10.1007/s40123-025-01099-x. Epub 2025 Feb 21.
- 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.
Claudine Civiale study director
SIFI S.p.A.
4 sites 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 Syndromes, run by SIFI SpA at 4 sites in Spain.
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 7 inclusion and 11 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: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Keratitis lesions (time frame: 1 month). 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 NCT05778942, 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 6 Feb 2024.