In short
Two Phase 3 trials are registered: one was completed with 40 participants and one was withdrawn with a planned enrolment of 100.
Key points
- The completed trial enrolled 40 participants with an ocular prosthesis and chronic mucopurulent discharge or discomfort.
- A second Phase 3 trial with a planned 100 participants was withdrawn before it started.
- The main measure was the change in discomfort and discharge scores after two weeks of use.
- The product is authorised as a medicine in the Netherlands under the name Hylan 0.15/0.15 mg/ml eye drops.
- The substance is given as eye drops by ophthalmic use.
How does carbomer 981 work?
When applied as an eye drop, the polymer forms a thin, moist film that coats the ocular surface. This film helps to retain water and to reduce friction between the eyelid and the surface of the eye or an ocular prosthesis.
Which conditions is carbomer 981 used or studied for?
- Chronic mucopurulent discharge and/or discomfort of the ocular prosthesis socket — a long-lasting condition in which people who wear an artificial eye experience irritation and a sticky, pus-like discharge from the eye socket.
Beyond the registered trials, the product information in the registry describes the substance as an authorised medicine for ophthalmic use, which is consistent with its role as a tear substitute for dry or irritated eyes, although the registry data provided here do not list further authorised indications.
How is carbomer 981 given?
The combination product is formulated as eye drops, solution, and is given by ophthalmic use, meaning it is instilled directly into the eye. In the completed trial, the dose used was 4 drops of the Hylan solution. The comparison arms in the same trial used retinol palmitate (vitamin A) ophthalmic ointment, given as one dosage form, and FML Liquifilm 0.1% (fluorometholone) eye drops, given as 2 drops.
What do the clinical trials show?
Two Phase 3 trial records are registered for this substance combination. One trial, with the EU CT number 2023-504451-27-01, was completed and enrolled 40 participants. The other, 2023-504451-27-00, was withdrawn before it started and had a planned enrolment of 100 participants. Both trials had the same objective: to compare artificial tears, topical vitamin A ointment and low-dose topical steroids in people with an artificial eye who have chronic irritation or excess discharge.
The main measure in both trial records was the change in discomfort score and discharge score from baseline after two weeks of use of one of the three treatments. In plain words, the trials asked whether the eye drops or ointments reduced the feeling of irritation and the amount of discharge over a two-week period. The completed trial was interventional, meaning participants were assigned to a treatment.
Participants in these trials were people who wore an ocular prosthesis and had chronic mucopurulent discharge or discomfort of the socket. The registry records do not provide further details on age limits or other inclusion criteria. Because one of the two trials was withdrawn, the available evidence on this comparison comes from the completed trial with 40 participants.
What side effects are known?
Because the product is authorised as a medicine, its safety information is assessed through the usual pharmacovigilance channels, but no specific adverse events are listed in the trial data supplied.