Preservative-free trehalose, sodium hyaluronate and NAAGA eye drops for dry eye
Effect of a New Preservative-free Combination of Trehalose, Sodium Hyaluronate and N-acetyl-aspartyl-glutamate (NAAGA) on Dry Eye Disease and Patient Quality of Life
This will try preservative-free eye drops combining trehalose, sodium hyaluronate, and NAAGA in adults with dry eye to see if symptoms and flare-ups improve over 6 months.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Laboratoires Thea Industry-sponsored |
| Locations | 1 site (Varna) |
| Trial ID | NCT06903741 on ClinicalTrials.gov |
What this trial studies
This is a prospective, non-randomized, non-comparative, single-center post-market follow-up enrolling 30 adults with dry eye disease to use the T2769 eye drops daily and complete self-questionnaires. Performance and safety will be measured at 3 and 6 months, with monitoring of patient compliance and occurrence of dry-eye flares. The study enrolls patients with at least three months of symptoms and an OSDI score of 13 or higher, including those not using artificial tears or unsatisfied with their current tears. Safety exclusions include hypersensitivity to components, pregnancy or breastfeeding, lack of adequate contraception in women of childbearing potential, and systemic conditions that could interfere with results.
Who should consider this trial
Good fit: Adults (≥18) with at least three months of dry-eye disease and an OSDI score ≥13 who are not using—or are unsatisfied with—current artificial tears are ideal candidates.
Not a fit: People with known hypersensitivity to the ingredients, pregnant or breastfeeding women, those without adequate contraception if applicable, or patients with severe ocular surface disease or incompatible systemic conditions may not receive benefit.
Why it matters
Potential benefit: If successful, the preservative-free combination could reduce dry eye symptoms and decrease the frequency of flare-ups while avoiding preservative-related irritation.
How similar studies have performed: Prior studies of trehalose and hyaluronate formulations have shown symptom improvement in dry eye, though combinations including NAAGA have been less extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women aged over 18 years, * Able to give written informed consent prior the initiation of any procedure, * History of dry eye syndrome for at least 3 months, * OSDI ≥13, * Never been treated with artificial tears or with no artificial tears at least 1 month before the enrolment, or not satisfied with current artificial tears. Exclusion Criteria: Systemic/non Ophthalmic Exclusion Criteria * Known or suspected hypersensitivity to one of the components of the IMD, * History of or active relevant systemic condition incompatible with the investigation or likely to interfere with the investigation results or the patient safety according to investigator judgment. Specific Exclusion Criteria Regarding Childbearing Potential Women * Pregnant or breast-feeding women, * Childbearing potential women neither surgically sterilised nor using an adequate contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring, patch) . Exclusion Criteria Related to General Conditions * Alcohol addiction and heavy smoker according to investigator's judgement, * Unable to understand the investigation procedures or to give informed consent, * Non-compliant (e.g., not willing to attend a visit or completing the self-questionnaire; way of life interfering with compliance), * Participant in this investigation at the same time as another clinical investigation/study, * Participant in this investigation within the exclusion period of a previous study/investigation with a minimum of one month, * Participant being institutionalized because of legal or regulatory order, inmate of psychiatric wards, prison or state institutions, or employee or family member of the investigation sites or of the Sponsor's company. Exclusion criteria related to previous and concomitant treatments (medications/non-medicinal therapies/procedures) • Participant with previous, current or anticipated prohibited listed treatment (or prohibited modification of treatment regimen).
Where this trial is running
Varna
- Group Practice Outpatient Clinic for Specialized Medical — Varna, Bulgaria (Recruiting)
Study contacts
- Study coordinator: Medical Affairs Director
- Email: Florence.NOIRT@theapharma.com
- Phone: +33473981436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.