Idroflog® for Treatment of Dry Eye Disease (IDROFLOG)

Sponsor

Alfa Intes Industria Terapeutica Splendore s.r.l. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05724056

Collaborator

(none)

130

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Device: Idroflog® Device: Sodium Hyaluronate 0.18% (Vismed®)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

In order to maintain the blinding of the Investigator and his team, both products will be placed into identical boxes ("blinding-box"), identified only by a randomization number, without any indication of product identity or randomization arm. Each patient will be randomly assigned a randomization number, allocating him/her to either Idroflog® or Sodium Hyaluronate 0.18% (1:1) in accordance with a central randomisation table generated using a validated computer-program. Randomisation will be stratified per center and performed using a permuted random block design.

Primary Purpose:

Treatment

Official Title:

Comparison of the Efficacy and Safety of Idroflog® (Sodium Hyaluronate and Hydrocortisone) and Sodium Hyaluronate for the Treatment of Dry Eye Disease

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Idroflog® Patients randomized in this group will be treated with Sodium Hyaluronate 2 mg/ml and Hydrocortisone 10 μg/ml.	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. Other Names: Study intervention
Active Comparator: Sodium Hyaluronate 0.18% (Vismed®) Patients randomized in this group will be treated with Sodium Hyaluronate 0.18%.	Device: 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. Other Names: Control intervention

Arm

Intervention/Treatment

Experimental: Idroflog®

Patients randomized in this group will be treated with Sodium Hyaluronate 2 mg/ml and Hydrocortisone 10 μg/ml.

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.

Other Names:

Study intervention

Active Comparator: Sodium Hyaluronate 0.18% (Vismed®)

Patients randomized in this group will be treated with Sodium Hyaluronate 0.18%.

Device: 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.

Other Names:

Control intervention

Outcome Measures

Primary Outcome Measures

Change From Baseline in fluorescein corneal Staining (Oxford Scale 0-5) between inclusion and 30 days [0 to 30 days of treatment]

Secondary Outcome Measures

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]
Change in OSDI between inclusion and 30, 60 and 90 days. [0 to 30, 60 and 90 days of treatment]
Change in Tear Film Break Up Time between inclusion and 30, 60 and 90 days [0 to 30, 60 and 90 days of treatment]
Change in Pentascore score between inclusion and 30, 60 and 90 days [0 to 30, 60 and 90 days of treatment]
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]
Safety 1: Changes in intraocular pressure between inclusion and 30, 60 and 90 days [0 to 30, 60 and 90 days of treatment]
Safety 2: Changes in visual acuity between inclusion and 90 days [0 to 90 days of treatment]

Other Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU Amiens-Picardie	Amiens	France	80054
2	CHO Bordeaux - Site Pellegrin Centre François-Xavier Michelet, Service Ophtalmologie	Bordeaux	France	33076
3	CHU Bicêtre, Service Ophtalmologie	Le Kremlin-Bicêtre	France	94270
4	CHNO des 15-20	Paris	France	75012
5	Hopital Fondation Adolphe de Rotschild	Paris	France	75019