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Study of TOP1630 for Dry Eye Syndrome

NCT03833388 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2019-08-07

No results posted yet for this study

Summary

In subjects with Dry Eye Syndrome (DES):

The primary objective of this study is to confirm the efficacy of TOP1630 0.1% Ophthalmic Solution TID OU compared to placebo treatment at Day 29 on pre-specified sign and symptom endpoints in subjects with moderate to severe DES.

Conditions

  • Dry Eye Syndrome

Interventions

DRUG

TOP1630 0.1% Ophthalmic Solution TID OU

Bilateral ocular drug administration

DRUG

Placebo to TOP1630 0.1% Ophthalmic Solution TID OU

Bilateral ocular drug administration

Sponsors & Collaborators

  • Topivert Pharma Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-13
Primary Completion
2019-05-14
Completion
2019-05-14
FDA Drug
Yes

Countries

  • United States

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 NCT03833388 on ClinicalTrials.gov