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Clinical Trial to Compare the Safety and Efficacy of Nanodrop®

NCT04111965 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2025-07-16

Study results available
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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

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

Sponsors & Collaborators

  • Laboratorios Sophia S.A de C.V.

    lead INDUSTRY

Principal Investigators

  • Leopoldo Baiza Durán, MD · Laboratorios Sophia S.A de C.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-12-10
Completion
2021-12-10

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04111965 on ClinicalTrials.gov