NCT04111965

Clinical Trial to Compare the Safety and Efficacy of Nanodrop®

Phase I-II Clinical Trial to Compare the Safety and Efficacy of Nanodrop® Against Systane® Balance in the Treatment of Dry Eye Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Nanodrop®	minimum to meet 1 drop 4 times a day, both eyes
DRUG	Systane Balance	minimum to meet 1 drop 4 times a day, both eyes

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-12-10
• Completion: 2021-12-10
• First posted: 2019-10-02
• Last updated: 2025-07-16
• Results posted: 2025-07-16

Locations

6 sites across 1 country: Mexico