Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Ongoing, recruiting
Participants planned
30
Countries
1
Sites
1
inflammatory secretions of the conjunctiva (Eye desease)
To study the efficacy of two topical molecules on the secretions of patients with prostheses: Hydrocortisone and Dexamethasone versus a tear substitute, DULCILARMES®, which will serve as a comparator.
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Rennes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11], Phenomena and Processes [G] - Ocular Physiological Phenomena [G14], Phenomena and Processes [G] - Immune system processes [G12]
- Trial duration
- 30 Oct 2024 → ongoing
- Decision date (initial)
- 2024-10-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- CHU Rennes · THEA
External identifiers
- EU CT number
- 2024-517441-14-00
- EudraCT number
- 2021-003794-56
- ClinicalTrials.gov
- NCT05668455
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To study the efficacy of two topical molecules on the secretions of patients with prostheses: Hydrocortisone and Dexamethasone versus a tear substitute, DULCILARMES®, which will serve as a comparator.
Secondary objectives 3
- To assess the effect of treatments on : 1) conjunctival inflammation
- To assess the effect of treatments on : 2) secretions
- To assess the effect of treatments on : 3) quality of life
Conditions and MedDRA coding
inflammatory secretions of the conjunctiva (Eye desease)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLT | 10030045 | Ocular infections inflammations and associated manifestations | 10015919 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Patient aged 18 years or older
- Wearing a permanent prosthesis for more than 6 months
- Modified OSDI score ≥ 13 points out of 40 ;
- Affiliated to a health insurance scheme,
- Having given free, informed and written consent.
- Consultant in the ophthalmology department
Exclusion criteria 9
- Treatment with eye drops (other than artificial tears or antiseptic) < 1 month
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.)
Secondary endpoints 3
- 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.)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
DEXAFREE 1 mg/ml, collyre en solution en récipient unidose
PRD317019 · Product
- Active substance
- Dexamethasone Phosphate
- Pharmaceutical form
- EYE DROPS, SOLUTION
- Route of administration
- TOPICAL ADMINISTRATION
- Max daily dose
- 360 µg microgram(s)
- Max total dose
- 5040 µg microgram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- S01BA01 — DEXAMETHASONE
- Marketing authorisation
- 34009 374 774 5 1
- MA holder
- LABORATOIRES THEA
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- used for its anti-inflammatory action in the eye cavity
SOFTACORT 3,35 mg/ml, collyre en solution en récipient unidose
PRD5284446 · Product
- Active substance
- Hydrocortisone Sodium Phosphate
- Pharmaceutical form
- EYE DROPS, SOLUTION
- Route of administration
- TOPICAL ADMINISTRATION
- Max daily dose
- 0.48 mg milligram(s)
- Max total dose
- 6.72 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- S01BA02 — HYDROCORTISONE
- Marketing authorisation
- 34009 300 956 1 4
- MA holder
- LABORATOIRES THEA
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- used for its anti-inflammatory action in the eye cavity
Comparator 1
DULCILARMES 1,5%, collyre en solution en récipient unidose
PRD1864439 · Product
- Active substance
- Povidone
- Pharmaceutical form
- EYE DROPS, SOLUTION
- Route of administration
- TOPICAL ADMINISTRATION
- Max daily dose
- 4 U unit(s)
- Max total dose
- 56 U unit(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- S01X — OTHER OPHTHALMOLOGICALS
- Marketing authorisation
- 279 562-4 OU 34009 279 562 4 9
- MA holder
- HORUS PHARMA
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- used in the eye cavity
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Rennes
- Sponsor organisation
- Centre Hospitalier Universitaire De Rennes
- Address
- 2 Rue Henri Le Guilloux
- City
- Rennes Cedex 9
- Postcode
- 35033
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Rennes
- Contact name
- Frédéric MOURIAUX
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Rennes
- Contact name
- Frédéric MOURIAUX
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Rennes
Ophtalmology, 2 Rue Henri Le Guilloux, 35033, Rennes Cedex 9
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-10-30 | 2024-10-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_redacted_clean_2024-517441-14_CRYSTAL | 5 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_CRYSTAL | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material description_Poster_2024-517441-14-00_CRYSTAL | 1 |
| Subject information and informed consent form (for publication) | D4_Patient Facing document_Patient Card_CRYSTAL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_clean_2024-517441-14_CRYSTAL | 5 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Dexafree_2024-517441-14_CRYSTAL | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Dulcilarmes_2024-517441-14_CRYSTAL | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Softacort_2024-517441-14_CRYSTAL | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis EN_Redacted_Clean_2024-517441-14_ CRYSTAL | 5 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_redacted_clean_2024-517441-14_CRYSTAL | 5 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-07 | France | Acceptable 2024-10-25
|
2024-10-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-16 | France | Acceptable 2025-05-26
|
2025-06-05 |