Anti-inflammatory Effects and Clinical Efficacy of Topical Thealoz Total Eye Drops in Patients Wi… (NCT07245836) | Clinical Trial Compass
TerminatedPhase 4
Anti-inflammatory Effects and Clinical Efficacy of Topical Thealoz Total Eye Drops in Patients With Chronic Dry Eye Disease and Associated Ocular Surface Inflammation
Stopped: This study was not halted prematurely. This record represents a duplicate entry and has therefore been withdrawn. The correct and complete study information can be found under identifier NCT07007702.
Austria30 participantsStarted 2025-01-20
Plain-language summary
Dry eye disease (DED) is a highly prevalent ocular condition and induces a significant burden to the affected patients. Regardless of the underlying etiology, DED is associated with increased inflammation of the entire ocular surface including the adnexa, conjunctiva and cornea. As such, there is evidence from in vitro, animal and clinical studies that this inflammatory response of the ocular surface plays a pathophysiological key role in the development of DED. The Dry Eye Workshop 2007 (DEWS) therefore suggests beside of restoring the tear film by administering topical lubricants, breaking the vicious circle of inflammation is an important mainstay of therapy in patients with DED. Recently, a new medical device (Thealoz Total® eye drops) has been introduced for the treatment DED. Thealoz Total® eye drops are based on hyaluronic acid and exert their main action by lubricating the ocular surface. Further, this new formulation offers several advantages that make them potentially interesting to reduce DED related symptoms. First, the formulation is preservative-free, which is of special importance in patients with DED, since it has been shown that preservatives are detrimental for the ocular surface. thereby reducing signs and symptoms related to DED. Secondly, in addition to the lubricating effect of hyaluronic acid, Thealoz Total eye drops also contain trehalose, which exerts osmoprotetive effects and N-Acetyl Aspartyl Glutamic Acid (NAAGA). NAAGA is an amino conjugated dipeptide with anti-inflammatory properties. Thus, it is reasonable to hypothesize that Thealoz total eye drops are also capable of reducing ocular surface inflammation. The aim of the present study is to investigate whether topical administration with Thealoz Total® improves ocular surface inflammation as well as clinical signs and symptoms associated with DED.
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
* 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-uterine device, contraceptive implant o…
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.
1This trial was terminated before completing — do you know why it ended early, and does that affect whether Thealoz Total Eye Drops would still be worth trying for my dry eye disease?
2Since this was a Phase 4 trial testing an already-approved product, does that mean there's existing safety data on these drops, and how does that compare to what I'm currently using?
3The trial was measuring conjunctival redness using a grading scale at 12 weeks — based on what you know about my level of eye surface inflammation, is that a realistic timeframe to expect any meaningful change?
4Patient satisfaction was one of the main things being measured — does that suggest this is more about quality of life improvement than treating an underlying cause, and how does that fit with what's driving my dry eye symptoms?
5Since the trial was terminated, is there a completed study or existing clinical evidence on Thealoz Total Eye Drops that you'd feel comfortable basing a treatment recommendation on for me?
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 assessed by a VAS
Timeframe: week 12
2
Conjunctival hyperemia grading with Photographs (Efron) scale at week 12