Anti-inflammatory Effects and Clinical Efficacy of Topical Thealoz Total Eye Drops in Patients Wi… (NCT07007702) | Clinical Trial Compass
CompletedNot Applicable
Anti-inflammatory Effects and Clinical Efficacy of Topical Thealoz Total Eye Drops in Patients With Chronic Dry Eye Disease
Austria30 participantsStarted 2025-01-27
Plain-language summary
The goal of this prospective, open, monocentric study is to evaluate the clinical efficacy of a new preservative-free combination of trehalose, sodium hyaluronate and NAAGA in 30 patients with chronic dry eye disease and associated ocular surface inflammation.
The main question it aims to answer is:
\- To assess the improvement of conjunctival hyperemia as well as subjective symptoms in patients with moderate to severe dry eye.
Participants will be asked to use T2769 on a daily basis.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Normal ophthalmic findings except dry eye disease
* Chronic dry eye defined as longer than six months since diagnosis
* OSDI ≥ 22
* Conjunctival Hyperemia≥ Grade 3 (Efron Scale)
* Current use of topical lubricants since at least 3 months
Exclusion Criteria:
Ophthalmic exclusion criteria
* Best far corrected visual acuity \< 1/10
* Severe Dry Eye associated with:
* Eyelid malposition
* Sjogren Syndrome
* Stevens Johnson Syndrome
* Corneal dystrophy
* Ocular neoplasia
* Filamentous keratitis
* Corneal neovascularisation
* Orbital radiotherapy
* Dry eye related to GVHD
* History of any of the following within last 3 months:
* Systemic treatment of dry eye
* Systemic treatment of MGD
* Isotretinoïde,
* Cyclosporine,
* Tacrolimus, Siromilus, Pimecrolimus
* Punctual plugs
* History of any of the following within previous six months:
* ocular trauma
* ocular infection, Ocular allergy
* History of any of the following within last 12 months:
* inflammatory corneal ulcer
* Herpetic eye infection
* or uveitis
* Ocular surgery
Systemic / non ophthalmic exclusion criteria:
• Known hypersensitivity to any of the components of the medical device under investigation or other study medication
Specific exclusion criteria for women:
* Pregnant or breast-feeding woman.
* Woman of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception (i.e. hormonal contraceptives, intra-u…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient satisfaction with Visual Analog Scale (0-10) at week 12 - Descriptive analysis
Timeframe: at week 12
2
Conjunctival hyperaemia assesment with Efron scale at week 12