Clinical Trial to Compare the Safety and Efficacy of Nanodrop®
Status:
Recruiting
Trial end date:
2021-07-30
Target enrollment:
Participant gender:
Summary
Study design:
Phase I-II clinical trial, comparative, non-inferiority with active control, parallel groups,
double blind with randomisation. Safety analysis when completing the visits of the first 12
subjects of the Nanodrop® group, if there are less than 20% of unexpected Events (EA),
related to the research product, recruitment is continued until the sample is completed for
efficacy analysis
objectives Security: Evaluate the safety of the ophthalmic application of Nanodrop® by
quantifying the incidence of unexpected Adverse Events (EA) related to the research product
(PI).
Effectiveness: Demonstrate the non-inferiority of Nanodrop® compared to Systane® Balance, in
the efficacy of the treatment of patients with dry eye, by means of the Ocular Surface
Disease Index (OSDI).
Hypothesis
Security:
H0 = Nanodrop® is safe in its ophthalmic application as it presents an incidence of
unexpected adverse events related to the research drug, less than 20% of the population of
Nanodrop® safety group.
H1 = Nanodrop® is not safe in its ophthalmic application, as it presents an incidence of
unexpected adverse events related to the research drug, exceeding 20% of the population of
Nanodrop® safety group.
Effectiveness:
H0 = Nanodrop® is lower than Systane® Balance by more than 5 points in the OSDI test score.
H1 = Nanodrop® is lower than Systane® Balance by 5 points or less in the OSDI test score.
Number of subjects: n = 126 evaluable subjects 63 evaluable subjects per group (both eyes).
Main inclusion criteria: Dry eye diagnosis
Duration of intervention treatment: 28 days Approximate duration of the subject in the study:
35 days