An observational study in Dry Eye Syndromes, sponsored by SIFI SpA. Completed at 4 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-06.
Sponsored by SIFI SpA · Observational
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Among 43 studies in Dry Eye Syndromes with a site in Spain — 3 open to participants now, 4 under way, none of them phase 3. Dry Eye Syndromes · Spain.
Among the 43 studies in Dry Eye Syndromes with a site in Spain, this one is one of 4 that started in 2023, is one of 3 observational ones, and was the 29th registered.
1,367 studies on the registry are indexed under Dry Eye Syndromes; 208 are open to participants now.
Browse Dry Eye Syndromes studies →3 of the 43 studies in Dry Eye Syndromes with a site in Spain are open now. Recruiting first, the newest first:
Barbara Burgos Blasco · Sites in Spain
Ages 18+
Laboratorios Thea, Spain · Sites in Spain
Ages 18+
NOXELIS · Sites in Spain
Ages 18–78
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 116 Dry Eye Syndromes studies recruiting now, 73 (63%) set no upper age limit and 24 (21%) stop at 75 or younger; 7 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
43 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 8 · Phase 3 8 · Phase 4 5
First in 2009; this study’s year is marked. 4 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 35 is below the median of 88 across 191 observational studies indexed under Dry Eye Syndromes.
Median enrollment 63 across the 40 interventional studies, 314 across the 3 observational. Of the 36 that completed or were terminated, 5 (14%) have results posted.
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28 of 43 have an industry lead sponsor. The 10 most frequent:
SIFI SpA is the lead sponsor of 19 studies on the registry; none are open to participants now.
SIFI SpA has 5 studies filed under Dry Eye Syndromes — fewer than ten, so there is no comparison to draw.
2 of the studies in Dry Eye Syndromes with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06928142Otsuka Pharmaceutical Development & Commercialization, Inc.A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's | 2027-03-13 |
| NCT07715266NOXELISPOST CATARACT SURGERY DRY EYE DISEASE | 2027-05 |
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Among the 43 studies in Dry Eye Syndromes with a site in Spain, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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
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 compare patients reported outcomes with baseline, using specifically:
Male and female subjects with signs and symptoms of ocular discomfort resulting from ocular dryness.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects with ocular discomfort resulting from eye dryness in one or both eyes as determined by:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single arm with commercial study drug: Eyestil SYNFO
Device: Eyestil SYNFO
Instillation of study drug in both eyes: preservative-free ophthalmic solution based on sodium hyaluronate and xanthan gum
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.
Time frame: 1 month
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.
Time frame: Day 14 and at 3 months
Conjuctival Hyperemia
To evaluate conjunctival hyperemia index by OCULUS keratograph
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 1 and 3 months
DEQS Questionnaire
To compare patients reported outcomes with baseline, using the Dry Eye-Related Quality-of-Life Score (DEQS) questionnaire
Time frame: 1 and 3 months
Number of Adverse Events
To evaluate the safety through general assessment of adverse events
Time frame: From date of randomization up to 3 months
Investigator Global Assessment Score
To evaluate the safety using the Investigator Global Assessment Score
Time frame: From date of randomization up to 3 months
Intra Ocular Pressure
To evaluate the safety using the measurement of the intraocular pressure
Time frame: 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
Time frame: Day 14, 1 month and 3 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2023 to primary completion in Nov 2023, 8 months.
Of 69 observational studies under Dry Eye Syndromes, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 64. This study's 8 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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SIFI SpA