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Compares treatment options for Dry Eye Syndromes
Official title Clinical Investigation Between the Topical Administration of a Tear Substitute With Ancillary Medicinal Substance and Hyaluronic Acid 0.3% (FBV_01) vs Hyaluronic Acid 0.3% in Subjects in the Treatment From Moderate to Severe DED
ClinicalTrials.gov ID: NCT07412860
What this study is testing
- What it's testing
- The goal of this clinical investigation plan is to evaluate the performance, tolerability, safety, and compliance of an ophthalmic solution containing an ancillary medicinal substance and hyaluronic acid 0.3% (FBV\_01) compared with hyaluronic acid 0.3% alone in adult men and women (≥18 years) with moderate-to-severe dry eye syndrome. The main questions it aims to answer are: Is the ophthalmic solution containing an ancillary medicinal substance and hyaluronic acid non-inferior in improving the clinical performance outcomes of dry eye compared with hyaluronic acid alone?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients able to provide written Informed Consent, in accordance with good clinical practice and current legislation;
- Patients (male and female) 18 years of age or older with moderate to severe dry eye syndrome or with dry eye syndrome, even after eye surgery (e.g...
- Moderate to severe dry eye syndrome in one or both eyes in the presence of:
- Dry Eye Symptom Assessment Questionnaire (SANDE) \> 60;
- Tear Film Break-Up Time (TFBUT) \< 7 seconds. TFBUT value will be recorded as an average of 3 measurements;
You likely can't join if
- Eye infection or clinically significant inflammation in both eyes (for example: Herpes simplex infections, corneal virus infections, bacterial, viral...
- History or evidence of eyelid abnormalities in either eye;
- Use of topical cyclosporine, topical corticosteroids, or any other topical medication for the treatment of ocular pathologies in either eye within 7...
- Patients being treated with chronic systemic therapies with analgesic, anti-inflammatory, corticosteroids, or opioids;
- History of ocular surgery (including laser procedures or refractive surgery) in either eye 7 days prior to enrollment;
- History or evidence of severe or uncontrolled systemic or autoimmune disease does not allow participation in the study or could impair the results;
See the full eligibility criteria
- Patients able to provide written Informed Consent, in accordance with good clinical practice and current legislation;
- Patients (male and female) 18 years of age or older with moderate to severe dry eye syndrome or with dry eye syndrome, even after eye surgery (e.g. refractive surgery or cataract);
- Moderate to severe dry eye syndrome in one or both eyes in the presence of:
- Dry Eye Symptom Assessment Questionnaire (SANDE) \> 60;
- Tear Film Break-Up Time (TFBUT) \< 7 seconds. TFBUT value will be recorded as an average of 3 measurements;
- Test di Schirmer \< 10 mm;
- Diagnosis of dry eye syndrome for at least 6 months (use or recommendation of use of artificial tears/lubricants for the treatment of dry eye);
- Patients able to understand the nature and purpose of the study, including possible risks;
- Patient able to cooperate with the Investigator and meet the requirements of the clinical investigation plan;
- Patient who, in the opinion of the Investigator, will benefit from this treatment;
- Patient available for the entire study period.
- Eye infection or clinically significant inflammation in both eyes (for example: Herpes simplex infections, corneal virus infections, bacterial, viral or fungal conjunctivitis, tuberculosis and mycosis of the eye...
- History or evidence of eyelid abnormalities in either eye;
- Use of topical cyclosporine, topical corticosteroids, or any other topical medication for the treatment of ocular pathologies in either eye within 7 days of study enrollment;
- Patients being treated with chronic systemic therapies with analgesic, anti-inflammatory, corticosteroids, or opioids;
- History of ocular surgery (including laser procedures or refractive surgery) in either eye 7 days prior to enrollment;
- History or evidence of severe or uncontrolled systemic or autoimmune disease does not allow participation in the study or could impair the results;
- Patients being treated with drugs and/or medical devices and/or supplements for neuropathic pain (e.g., SNRIs (duloxetine, venlafaxine), pregabalin, gabapentin, TCAs (nortriptyline, amitriptyline));
- Patient with known or potential allergy or hypersensitivity and/or history of allergic reactions to one of the components of the medical device;
- Participation in another clinical trial within 30 days prior to the screening visit;
- History of administration or abuse of drugs, medications, or alcohol;
- Women of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) will be excluded from participation in the study if they meet any of the following conditions:
- are currently pregnant or,
- have a positive urine pregnancy test result at visit 1,
- intend to become pregnant during the study treatment period or,
- are breastfeeding or, unwilling to resort to highly effective birth control measures, such as: hormonal contraceptives oral, implanted, transdermal or injected and/or mechanical barrier methods spermicidal concurrently...
- Subject unable to follow clinical investigation procedures and follow-up visits;
- Any other medical condition which, in the opinion of the Investigator, could influence participation in the clinical investigation or compromise its results.
The study team makes the final eligibility decision.
Where it's taking place
- Cagliari, CA, Italy
- Catanzaro, CZ, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cagliari, CA, Italy; Catanzaro, CZ, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.