Glaucoma
Conditions
Brief summary
rate of change in MD in the study eye, an index of the global deviation of the age-corrected normal values. The objective is to assess the difference in the rate of progression over 3 years of study in the experimental arm compared to the control arm
Detailed description
To establish differences in the rate of change of structural thickness (peripapillary Retinal Nerve Fibre Layer (RNFL) with Optical Coherence Tomography – OCT) and macular thickness of the inner retina (RNFL, Ganglion Cell Layer and Ganglion Cell + Inner Plexiform Layer complex evaluated by SD-OCT)
Interventions
DRUGPlacebo eye drops: vehicle
DRUGHyaluronic acid: 0.02 g; Benzalkonium chloride: 0.001g; water for injection up to 10 ml
DRUGCiticoline
Sponsors
Omikron Italia S.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of change in MD in the study eye, an index of the global deviation of the age-corrected normal values. The objective is to assess the difference in the rate of progression over 3 years of study in the experimental arm compared to the control arm | — |
Secondary
| Measure | Time frame |
|---|---|
| To establish differences in the rate of change of structural thickness (peripapillary Retinal Nerve Fibre Layer (RNFL) with Optical Coherence Tomography – OCT) and macular thickness of the inner retina (RNFL, Ganglion Cell Layer and Ganglion Cell + Inner Plexiform Layer complex evaluated by SD-OCT) | — |
Countries
Belgium, France, Greece, Hungary, Italy, Poland, Spain
Outcome results
None listed