Idroflog® for Treatment of Dry Eye Disease (IDROFLOG)

Launched by ALFA INTES INDUSTRIA TERAPEUTICA SPLENDORE S.R.L. · Feb 2, 2023

Keywords

ClinConnect Summary

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 hy...

Gender

ALL

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