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Influence of Perfluorohexyloctane (NovaTears) on Tear Film Thickness in Patients With Mild to Moderate Dry Eye Disease

N

Novaliq

Status

Completed

Conditions

Dry Eye Disease

Treatments

Device: Hydrabak®
Device: NovaTears®

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

48 participants in 2 patient groups

NovaTears®
Experimental group
Treatment:
Device: NovaTears®
Hydrabak®
Active Comparator group
Description:
Unpreserved sodium chloride (0.9%) eye drops in ABAK® system
Treatment:
Device: Hydrabak®

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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