Comparison of Topical Treatment for Inflammatory Secretions of the Conjonctiva (Patients With Ocular Prostheses)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAgnes
About this trial
We propose to evaluate the efficacy of treatment with Hydrocortisone and Dexamethasone (in a cross-over design) in patients with ocular prostheses and significant functional discomfort.
Eligibility criteria
Qualifiers
Patient aged 18 years or older;
Wearing a permanent prosthesis for more than 6 months; - Consultant in the ophthalmology department;
Modified OSDI score ≥ 20 points out of 40 ;
Affiliated with a health insurance scheme,
Disqualifiers
Treatment with eye drop(s) (other than artificial tears or antiseptic) < 1 month;
Concomitant treatment with CYP3A inhibitors including cobicistat containing drugs,
Known contraindications to study treatments
Dermal fat grafting or complicated cavity;
Trial design
Treatments tested in this trial
- Hydrocortisone
- Dexamethasone
- Povidone
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Agnes
Lead sponsor
Rennes University Hospital
Sponsor institution
Direction Générale de l'Offre de Soins
Collaborator
Laboratoires Thea
Collaborator
Source ClinicalTrials.gov