Dexamethasone phosphate for Conjunctival inflammation (inflammatory secretions of the conjunctiva)

Inclusion criteria

• {"criterion_text":"- Patient aged 18 years or older\n- Wearing a permanent prosthesis for more than 6 months\n- Modified OSDI score ≥ 13 points out of 40 ;\n- Affiliated to a health insurance scheme,\n- Having given free, informed and written consent.\n- Consultant in the ophthalmology department"}

Exclusion criteria

• {"criterion_text":"- Treatment with eye drops (other than artificial tears or antiseptic) < 1 month\n- Fatty dermal graft or complicated cavity\n- Gougerot-Sjögren syndrome\n- Allergic conjunctivitis\n- Damaged prosthesis\n- Impossibility of carrying out the various tests required by the protocol for whatever reason (comprehension problems, motor disability)\n- Pregnant or breastfeeding woman\n- Person already included in a RIPH1 research protocol with topical treatment of the cavity or systemic anti-inflammatory treatment and/or who could lead to a bias in the present study\n- Person under legal protection (safeguard of justice, curatorship, guardianship) or person deprived of liberty"}

Primary endpoints

• {"endpoint_text":"- Secretion Self-Rating Scale score. This 40-point score is calculated as the sum of 4 criteria, each scored on 10 points. (Jacobs et al.; Maucourant et al.)","definition_or_measurement_approach":"40-point score calculated as the sum of 4 criteria, each scored on 10 points (per Jacobs et al.; Maucourant et al.)."}

Secondary endpoints

• {"endpoint_text":"- 1) Bulbar conjunctival inflammation score and tarsal conjunctival inflammation score according to the grades of Saini et al.","definition_or_measurement_approach":"Inflammation graded using the Saini et al. grading scales for bulbar and tarsal conjunctival inflammation."}
• {"endpoint_text":"- 2) Secretion frequency (score out of 10) according to the secretion analysis scale (Jacobs et al.) - Colour of secretions (score out of 10) according to the secretion analysis scale (Jacobs et al.) - Amount of secretions (score out of 10) according to the secretion analysis scale (Jacobs et al.) - Thickness/Viscosity of secretions (score out of 10) according to the secretion analysis scale (Jacobs et al.)","definition_or_measurement_approach":"Multiple secretion characteristics scored using the secretion analysis scale (Jacobs et al.), each on a 0–10 scale: frequency, colour, amount, thickness/viscosity."}
• {"endpoint_text":"- 3) OSDI quality of life score adapted to prosthesis wearers, scored on 40 points (10 items with a maximum of 4 points per item) (Maucourant et al.)","definition_or_measurement_approach":"OSDI adapted for prosthesis wearers: 10 items, scored 0–4 each, total up to 40 points (per Maucourant et al.)."}

France

Earliest CTIS Part Ii Submission Date

21-10-2024

Latest Decision Or Authorization Date

05-06-2025

Processing Time Days

227

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Rennes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"France","full_name":"THEA","duties_or_roles":"Source of monetary support","organisation_type":""}