Clinical trial NCT05724056: Idroflog® for Treatment of Dry Eye Disease (IDROFLOG)
Official title: Comparison of the Efficacy and Safety of Idroflog® (Sodium Hyaluronate and Hydrocortisone) and Sodium Hyaluronate for the Treatment of Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye Disease
Keywords: Dry Eye
Idroflog
Ocular
Lead sponsor: Alfa Intes Industria Terapeutica Splendore s.r.l.
Sponsor class: INDUSTRY
First posted: 2023-02-13
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be enrolled equally and randomly into either treatment group: Idroflog® or Sodium Hyaluronate 0.18% (Vismed®). Once randomized, participants will receive the intervention for 90 days, and will be followed up at 30 days, 60 days, and 90 days.
Primary purpose: TREATMENT

Brief summary: This study aims at demonstrating the non-inferiority of Idroflog compared to sodium hyaluronate 0.18% for the disease improvement of people with documented history of dry eyes and use of tear substitutes for at least 3 months.

Detailed description: This is a randomized, controlled, multicenter, assessor-blinded, non-inferiority trial comparing Idroflog® (sodium hyaluronate and hydrocortisone) with sodium hyaluronate in participants with dry eye disease (DED).

DED is a common, multifactorial ocular condition, which affects between 5% and 35% of adults worldwide and significantly affects their quality of life. DED treatment is based on the management of contributing factors (local environment, elimination of harmful systemic and topical drugs), eyelid hygiene and the use of artificial tears. The gold standard of the latter is sodium hyaluronate solutions, which, however, lack any anit-inflammatory activity necessary for DED's management. In comparison to these, Idroflog containing both sodium hyaluronate and hydrocortisone in addition to the usual activities of sodium hyaluronate artificial tears (diluent, diffusive, protective, nutrient, lubricant) also provides steroidal anti-inflammatory activity. Therefore, this study aims at showing that Idroflog® performs as well as current standard of care (sodium hyaluronate artificial tears) in the treatment of moderate DED, while providing a potential benefit on the control of the sub-clinical inflammatory component of DED and maintaining the excellent safety profile of sodium hyaluronate artificial tears treatment.

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Aged ≥ 18 years
* Documented history of dry eyes and use of tear substitutes for at least 3 months within the last year
* Presence of corneal fluorescein staining (Oxford Scale, Score ≥ 2) in at least one eye
* Ocular Surface Disease Index (OSDI) ≥ 23
* Reduced tear break-up time (\< 11 seconds)

Exclusion Criteria:

* Women who are pregnant or lactating
* Best far corrected visual acuity \< 1/10 in both eyes
* Known hypersensitivity to one of the components of the study medications or test products
* Use of any ocular topical medication other than the study medications for the treatment of ocular diseases including artificial tears during the study period
* Ocular surgery (of any type, including laser surgery and punctal plugs) or ocular trauma within the 4 months prior to screening
* Active ocular infection
* Active allergies requiring treatment
* Glaucoma

Primary outcomes:
measure: Change From Baseline in fluorescein corneal Staining (Oxford Scale 0-5) between inclusion and 30 days
timeFrame: 0 to 30 days of treatment
Secondary outcomes:
measure: Change From Baseline in fluorescein corneal Staining (Oxford Scale 0-5) between inclusion and 60 days, and between inclusion and 90 days.
timeFrame: 0 to 60 and 90 days of treatment
measure: Change in OSDI between inclusion and 30, 60 and 90 days.
timeFrame: 0 to 30, 60 and 90 days of treatment
measure: Change in Tear Film Break Up Time between inclusion and 30, 60 and 90 days
timeFrame: 0 to 30, 60 and 90 days of treatment
measure: Change in Pentascore score between inclusion and 30, 60 and 90 days
timeFrame: 0 to 30, 60 and 90 days of treatment
measure: Changes in Ocular Redness Scale (0-4; 0 = no ocular redness, 4 = extremely severe ocular redness) between inclusion and 30, 60 and 90 days
timeFrame: 0 to 30, 60 and 90 days of treatment
measure: Safety 1: Changes in intraocular pressure between inclusion and 30, 60 and 90 days
timeFrame: 0 to 30, 60 and 90 days of treatment
measure: Safety 2: Changes in visual acuity between inclusion and 90 days
timeFrame: 0 to 90 days of treatment
Other outcomes:
measure: Changes in non-specific inflammation markers (HLA-DR) at 30, 60 and 90 days in a subgroup of participants
timeFrame: 0 to 30, 60 and 90 days of treatment
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
city: Bordeaux
country: France
facility: CHO Bordeaux - Site Pellegrin Centre François-Xavier Michelet, Service Ophtalmologie
city: Le Kremlin-Bicêtre
country: France
facility: CHU Bicêtre, Service Ophtalmologie
city: Paris
country: France
facility: CHNO des 15-20
city: Paris
country: France
facility: Hopital Fondation Adolphe de Rotschild
Study officials:
affiliation: CHU Bicêtre, Service Ophtalmologie
name: Marc LABETOULLE, Pr.
role: PRINCIPAL_INVESTIGATOR
References: