In short
Oxytetracycline is an antibiotic from the tetracycline class, used here as part of an eye ointment called Sterdex in a clinical trial for severe eye chemical burns. The trial (2023-509713-37-00) is a Phase 2 study with 21 participants, evaluating whether subconjunctival injection of mesenchymal stem cells can preserve the eyeball. Oxytetracycline itself is already authorised as a medicine and appears in this trial as an auxiliary treatment.
Oxytetracycline is a tetracycline antibiotic that works by inhibiting bacterial protein synthesis. It is available as 250 mg tablets for oral use in the United Kingdom, though that specific product has been discontinued. In the clinical trial described on this page, oxytetracycline appears as part of the eye ointment Sterdex, where it is combined with dexamethasone.
Key points
- Oxytetracycline is a tetracycline antibiotic that blocks bacterial protein synthesis.
- In the clinical trial, it is part of the Sterdex eye ointment used as an auxiliary medicine.
- The trial is Phase 2, single-arm and open-label, with 21 participants.
- The condition studied is severe eye chemical burns (Dua stage VI).
- The main outcome is absence of corneal perforation six months after treatment.
- The trial status is Authorised, meaning it has been approved but results are not yet reported.
What is oxytetracycline?
Oxytetracycline belongs to the tetracycline class of antibiotics, which are protein-synthesis inhibitors. It is also known by synonyms including oxytetracycline hydrochloride, oxytetracycline dihydrate, and the trade name Terramycin. In the trial records, the substance is registered as "dexamethasone, oxytetracycline" because it forms a fixed combination with the corticosteroid dexamethasone in the eye ointment Sterdex. Oxytetracycline is already authorised as a medicine, with an authorisation record in France held by Laboratoires Thea.
How does oxytetracycline work?
Oxytetracycline works by inhibiting protein synthesis in bacteria, which prevents them from growing and multiplying. As a tetracycline derivative, it binds to the bacterial ribosome and blocks the production of essential proteins. In the Sterdex eye ointment, oxytetracycline is combined with dexamethasone, a corticosteroid that reduces inflammation, providing both antibacterial and anti-inflammatory action in one formulation.
Which conditions is oxytetracycline used or studied for?
- Severe eye chemical burns — the clinical trial listed here uses Sterdex ointment containing oxytetracycline as an auxiliary treatment in patients with severe chemical burns of the ocular surface (Dua stage VI).
- Bacterial infections — as a tetracycline antibiotic, oxytetracycline is used against susceptible bacterial infections, and it is also approved for veterinary use.
How is oxytetracycline given?
Oxytetracycline is given as an eye ointment for ocular use in the Sterdex formulation used in the trial. It has also been available as 250 mg tablets for oral administration, though the specific product from Kent Pharma (UK) Ltd has been discontinued. The drug is described in DrugCentral as having indications for veterinary use as well as human medicine.
What do the clinical trials show?
One clinical trial in the EU Clinical Trials Information System involves oxytetracycline, where it serves as an auxiliary medicine rather than the main investigational treatment. The trial is a Phase 2, multicentre, single-arm, open-label study with 21 participants. The main treatment being investigated is subconjunctival injection of allogeneic bone marrow-derived mesenchymal stromal cells (BM-MSC), and Sterdex ointment containing oxytetracycline and dexamethasone is used as a supportive medicine.
The primary outcome is the absence of corneal perforation as assessed by the clinician, evaluated six months after the first injection. The trial status is Authorised, meaning it has received regulatory approval but results have not yet been published.
What side effects are known?
Research on oxytetracycline in human lymphocytes has examined its toxicological implications and inflammatory response, indicating that the compound can trigger cellular inflammatory processes. The study examined how human lymphocytes respond when challenged with oxytetracycline, suggesting potential toxicological effects at the cellular level. No other side effect information from the provided sources is available.