NCT03048526

Brief Summary

Patients with mild to moderate dry eye disease will be randomized to receive either NovaTears® or Hydrabak® eye drops as control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2017

Completed
Last Updated

July 5, 2017

Status Verified

July 1, 2017

Enrollment Period

4 months

First QC Date

February 7, 2017

Last Update Submit

July 3, 2017

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

  • Tear film thickness as measured with high resolution optical coherence tomography

    4 weeks

Secondary Outcomes (10)

  • Lipid layer thickness

    4 weeks

  • Non-invasive tear break up time

    4 weeks

  • Dynamic Meibomian Gland Imaging

    4 weeks

  • Blink frequency

    4 weeks

  • Symptom VAS

    4 weeks

  • +5 more secondary outcomes

Study Arms (2)

NovaTears®

EXPERIMENTAL
Device: NovaTears®

Hydrabak®

ACTIVE COMPARATOR

Unpreserved sodium chloride (0.9%) eye drops in ABAK® system

Device: Hydrabak®

Interventions

NovaTears®DEVICE

Topical eye drops for lubrication of the ocular surface

NovaTears®
Hydrabak®DEVICE

Eye drops

Hydrabak®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women aged over 18 years
  • History of dry eye disease for at least 3 months before the screening visit
  • Be able and willing to follow instructions, including participation in all study assessments and visits
  • Signed and dated written informed consent

You may not qualify if:

  • Have any clinically significant slit-lamp findings at the screening visit that may include trauma, Steven Johnson syndrome, and/or in the opinion of the investigator may interfere with study parameters
  • Participation in a clinical trial in the 4 weeks preceding the before the screening visit
  • Active ocular allergies or ocular allergies that are expected to be active during the study period
  • Pregnancy, planned pregnancy or lactating
  • Known hypersensitivity to any component of the study medication
  • Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Clinical Pharmacology

Vienna, A-1090, Austria

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Gerhard Garhoefer, MD

    Novaliq GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 9, 2017

Study Start

December 15, 2016

Primary Completion

April 18, 2017

Study Completion

April 18, 2017

Last Updated

July 5, 2017

Record last verified: 2017-07

Locations

AU(1)