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Safety and Efficacy of TOP1630 for Dry Eye Syndrome

NCT03088605 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2024-02-14

Study results available
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Summary

In subjects with Dry Eye Syndrome:

The primary objective of this study is to compare the safety and tolerability of TOP1630 Ophthalmic Solution to placebo.

The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye syndrome.

Conditions

  • Dry Eye Syndrome

Interventions

DRUG

TOP1630 Ophthalmic Solution

Bilateral ocular drug administration

DRUG

Placebo to TOP1630 Ophthalmic Solution

Bilateral ocular drug administration

Sponsors & Collaborators

  • Topivert Pharma Ltd

    collaborator INDUSTRY

  • ORA, Inc.

    lead INDUSTRY

Principal Investigators

  • G Torkildsen, MD · Andover Eye Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-20
Primary Completion
2017-06-15
Completion
2017-06-15
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 NCT03088605 on ClinicalTrials.gov