New eye drops aim to soothe stubborn dry eye
NCT ID NCT07234318
First seen Jun 26, 2026 · Last updated Aug 14, 2026 · Updated 2 times
Summary
This study tested cyclosporin 0.1% eye drops in 25 adults with moderate to severe dry eye disease that didn't get better with artificial tears. The goal was to see if the drops reduce eye dryness and redness. Participants used the drops alongside their usual tear substitutes for 12 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cyclosporin 0.1% eye drops
- What this could lead to
- If successful, this could provide a new treatment option for people with moderate to severe dry eye disease that hasn't improved with artificial tears.
- What could go wrong
- This is a small, completed study with only 25 participants. Results may not apply to everyone with dry eye, and cyclosporin eye drops can cause stinging or irritation.
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
-
25 people
The number who actually took part.
- Started
-
Jan 2026
- Finished
-
Jun 2026
- 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
Patients recruited in University of Vienna
- Ages
-
18 years and older
- Sex
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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 * No patients with other ophthalmic diseases than DED * Chronic dry eye defined as longer than six months since diagnosis * OSDI score \> 22 * Conjunctival Hyperemia ≥ Grade 3 (Efron Scale) * Current use of tear substitutes for at least 3 months not to be considered as sufficient by the investigator/treating physician * Need to add cyclosporine eye drops to tear substitutes as judged by the investigator/treating physician Exclusion Criteria: Ophthalmic exclusion criteria * Far best 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 Graft Versus Host Disease (GVHD) * History of any of the following within last 3 months: * Systemic treatment of dry eye * Systemic treatment of Meibomian Gland Dysfunction (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 product 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 with spermicide) 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
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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
-
Medical University of Vienna
Vienna, 1090, Austria
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