Idroflog® for Treatment of Dry Eye Disease (IDROFLOG)

NCT05724056 | Unknown

• 1 other identifier: 2022-A01171-42
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 5

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.

Conditions

Dry Eye Disease

Keywords

Dry Eye; Idroflog; Ocular

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in fluorescein corneal Staining (Oxford Scale 0-5) between inclusion and 30 days

  0 to 30 days of treatment

Secondary Outcomes (7)

• 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

Other Outcomes (1)

• 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

Study Arms (2)

Idroflog®

EXPERIMENTAL

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

Device: Idroflog®

Sodium Hyaluronate 0.18% (Vismed®)

ACTIVE COMPARATOR

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

Device: Sodium Hyaluronate 0.18% (Vismed®)

Interventions

Idroflog® DEVICE

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.

Also known as: Study intervention

Idroflog®

Sodium Hyaluronate 0.18% (Vismed®) DEVICE

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.

Also known as: Control intervention

Sodium Hyaluronate 0.18% (Vismed®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Alfa Intes Industria Terapeutica Splendore s.r.l.: lead

Study Sites (5)

CHU Amiens-Picardie

Amiens, 80054, France

Location

CHO Bordeaux - Site Pellegrin Centre François-Xavier Michelet, Service Ophtalmologie

Bordeaux, 33076, France

Location

CHU Bicêtre, Service Ophtalmologie

Le Kremlin-Bicêtre, 94270, France

Location

CHNO des 15-20

Paris, 75012, France

Location

Hopital Fondation Adolphe de Rotschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Marc LABETOULLE, Pr.

  CHU Bicêtre, Service Ophtalmologie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessio DAVID, Mr.

CONTACT

+39 388 1109878; alessio.david@alfaintes.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: March 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 13, 2023

Record last verified: 2023-01

Locations

FR (5)