NCT05724056

Idroflog® for Treatment of Dry Eye Disease (IDROFLOG)

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Alfa Intes Industria Terapeutica Splendore s.r.l. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-10-01
• Completion: 2023-12-01
• First posted: 2023-02-13
• Last updated: 2023-02-13

Locations

5 sites across 1 country: France