New eye drops aim to soothe dry, red eyes
NCT ID NCT07007702
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new preservative-free eye drop (Thealoz Total) in 30 adults with chronic dry eye and eye redness. Participants used the drops daily for 12 weeks. Researchers measured changes in redness and how satisfied patients felt. The goal was to see if the drops improve comfort and reduce inflammation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- trehalose, sodium hyaluronate, and N-Acetyl Aspartyl Glutamic Acid (NAAGA) in preservative-free eye drops
- What this could lead to
- If successful, this could offer a new option for people with chronic dry eye to reduce redness and feel more comfortable.
- What could go wrong
- This is a small, early study with only 30 people and no comparison group, so results may not apply to everyone. The drops are meant to ease symptoms, not cure dry eye.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
30 people
The number who actually took part.
- Started
-
Jan 2025
- Finished
-
Jun 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
A total of 30 patients with moderate to severe dry eye disease and associated inflammation.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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-uterine device, contraceptive implant or condoms) Exclusion criteria related to general conditions * Inability of patient to understand the investigation procedures and thus inability to give valid, informed consent. * Non-compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance) * Participation in another clinical study or clinical investigation at the same time as the present investigation * Participation to the present clinical investigation during the exclusion period of another clinical study * Patient already included once in this clinical investigation * Patient under guardianship
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Dry eye disease (DED) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Universitätsklinik für Klinische Pharmakologie, Allgemeines Krankenhaus Wien
Vienna, Austria
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gel plug in tear duct tested to keep eyes moist after cataract surgery
- Can a dissolvable eye plug deliver targeted relief for dry eye?
- Can a Light-Based scan reveal the health of your eyes?
- Can acne drug harm the eyes? new study investigates
- Which eye drop wins the dry eye battle? a Head-to-Head test
- Can a new eye drop soothe dry eye? a trial puts TRYPTYR to the test