REMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye

TRB Chemedica

Status: Terminated

Conditions: Dry Eye

Treatments: Device: Remogen; Device: Cationorm

Study type: Interventional

Funder types: Industry

Identifiers

NCT03460548

TOGA-CT-1501

Details and patient eligibility

About

The efficacy and safety of Remogen® Omega in the treatment of dry eye signs and symptoms will be investigated in comparison to Cationorm®.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• With at least a 3-month documented history of bilateral dry eye
• With a score of ocular surface staining with fluorescein (OSSF) ≥ 4 and ≤ 9 on the Oxford scale
• With at least one objective sign of tear deficiency
• With Ocular Surface Disease Index (OSDI) score of ≥ 18

Exclusion criteria

• Refractive surgery within 12 months prior to selection
• Any other ocular surgery or ocular trauma within 6 months prior to selection
• Systemic or local use of one of the following medications: glucocorticosteroids, cyclosporine A, antibiotics, NSAIDs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups

Remogen

Experimental group

Treatment:

Device: Remogen

Cationorm

Active Comparator group

Treatment:

Device: Cationorm