Idroflog® for Treatment of Dry Eye Disease (IDROFLOG)

Dry Eye Disease Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05724056
• Other study ID #: 2022-A01171-42
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2023
• Source: Alfa Intes Industria Terapeutica Splendore s.r.l.
• Contact: Alessio DAVID, Mr.
• Phone: +39 388 1109878
• Email: alessio.david[@]alfaintes.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Device:
• Idroflog®
The study intervention posology will be based on current labeling of Idroflog®. Participants will be self-administering one drop in each eye 4 times a day every day during the study period. Administration should follow the label guidelines. Participants should detach a single vial from the strip, remove the flap at the top by rotating it and instill 1 drop into the conjunctival sac of each eye, dropping them from above.
• Sodium Hyaluronate 0.18% (Vismed®)
The control intervention posology will be based on current labeling of Idroflog®. Participants will be self-administering one drop in each eye 4 times a day every day during the study period. Administration should follow the label guidelines. Participants should detach a single vial from the strip, remove the flap at the top by rotating it and instill 1 drop into the conjunctival sac of each eye, dropping them from above.

Locations

Country	Name	City	State
France	CHU Amiens-Picardie	Amiens
France	CHO Bordeaux - Site Pellegrin Centre François-Xavier Michelet, Service Ophtalmologie	Bordeaux
France	CHU Bicêtre, Service Ophtalmologie	Le Kremlin-Bicêtre
France	CHNO des 15-20	Paris
France	Hopital Fondation Adolphe de Rotschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Alfa Intes Industria Terapeutica Splendore s.r.l.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in non-specific inflammation markers (HLA-DR) at 30, 60 and 90 days in a subgroup of participants		0 to 30, 60 and 90 days of treatment
Primary	Change From Baseline in fluorescein corneal Staining (Oxford Scale 0-5) between inclusion and 30 days		0 to 30 days of treatment
Secondary	Change From Baseline in fluorescein corneal Staining (Oxford Scale 0-5) between inclusion and 60 days, and between inclusion and 90 days.		0 to 60 and 90 days of treatment
Secondary	Change in OSDI between inclusion and 30, 60 and 90 days.		0 to 30, 60 and 90 days of treatment
Secondary	Change in Tear Film Break Up Time between inclusion and 30, 60 and 90 days		0 to 30, 60 and 90 days of treatment
Secondary	Change in Pentascore score between inclusion and 30, 60 and 90 days		0 to 30, 60 and 90 days of treatment
Secondary	Changes in Ocular Redness Scale (0-4; 0 = no ocular redness, 4 = extremely severe ocular redness) between inclusion and 30, 60 and 90 days		0 to 30, 60 and 90 days of treatment
Secondary	Safety 1: Changes in intraocular pressure between inclusion and 30, 60 and 90 days		0 to 30, 60 and 90 days of treatment
Secondary	Safety 2: Changes in visual acuity between inclusion and 90 days		0 to 90 days of treatment