Idroflog® for Treatment of Dry Eye Disease (IDROFLOG)

Alfa Intes

Status: Not yet enrolling

Conditions: Dry Eye Disease

Treatments: Device: Idroflog®; Device: Sodium Hyaluronate 0.18% (Vismed®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05724056

2022-A01171-42

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups

Idroflog®

Experimental group

Description:

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

Treatment:

Device: Idroflog®

Sodium Hyaluronate 0.18% (Vismed®)

Active Comparator group

Description:

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

Treatment:

Device: Sodium Hyaluronate 0.18% (Vismed®)