COMPARISON OF HYDROCORTISONE EYE DROPS VERSUS DEXAMETHASONE EYE DROPS FOR THE TREATMENT OF INFLAMMATORY CONJUNCTIVAL SECRETIONS IN PATIENTS WITH OCULAR PROSTHESIS

COMPARISON OF TOPICAL HYDROCORTISONE VERSUS DEXAMETHASONE TREATMENT FOR INFLAMMATORY SECRETIONS OF THE CONJUNCTIVA IN PATIENTS WITH OCULAR PROSTHESIS - CRYSTAL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003794-56-FR

Enrollment

Registered

2024-09-11

Start date

2022-03-23

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conjunctival, Conjunctival inflammation, Corticosteroids, Inflammation, Prosthesis

Interventions

Trade Name: Dexafree Pharmaceutical Form: Ear/eye drops, solution Trade Name: SOFTACORT Pharmaceutical Form: Ear/eye drops, solution Trade Name: DULCILARMES Pharmaceutical Form: Ear/eye drops, solut

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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 to a health insurance scheme, - For women of childbearing potential: effective contraception (effective contraception includes oral contraception, intrauterine devices and other forms of contraception with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - Treatment with eye drops (other than artificial tears or antiseptic) < 1 month; - Concomitant treatment with CYP3A inhibitors including cobicistat containing drugs, - Known contraindications to study treatments; - Fatty dermal graft or complicated cavity; - Gougerot-Sjögren syndrome; - Allergic conjunctivitis; - Damaged prosthesis; - Impossibility of carrying out the various tests required by the protocol for whatever reason (comprehension problems, motor disability); - Pregnant or breastfeeding woman; - 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 - Person under legal protection (safeguard of justice, curatorship, guardianship) or person deprived of liberty.

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the efficacy of two topical molecules on the secretions of patients with prosthesis: Hydrocortisone and Dexamethasone versus a tear substitute, Dulcilarmes®, which will serve as a comparator;Secondary Objective: To assess the effect of treatments on : 1) conjunctival inflammation 2) secretions 3) quality of life ;Primary end point(s): 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.);Timepoint(s) of evaluation of this end point: After each treatment sequence	—

Measure

Time frame

Main Objective: To study the efficacy of two topical molecules on the secretions of patients with prosthesis: Hydrocortisone and Dexamethasone versus a tear substitute, Dulcilarmes®, which will serve as a comparator;Secondary Objective: To assess the effect of treatments on : 1) conjunctival inflammation 2) secretions 3) quality of life ;Primary end point(s): 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.);Timepoint(s) of evaluation of this end point: After each treatment sequence

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Secondary

Measure	Time frame
Secondary end point(s): 1) Bulbar conjunctival inflammation score and tarsal conjunctival inflammation score according to the grades of Saini et al. 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.) 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.) ;Timepoint(s) of evaluation of this end point: After each treatment sequence	—

Measure

Time frame

Secondary end point(s): 1) Bulbar conjunctival inflammation score and tarsal conjunctival inflammation score according to the grades of Saini et al. 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.) 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.) ;Timepoint(s) of evaluation of this end point: After each treatment sequence

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Countries

France

Contacts

Public ContactMOURIAUX

RENNES University Hospital

frederic.mouriaux@chu-rennes.fr0033299289036

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026