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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03048526

Enrollment

Registered

2017-02-09

Start date

2016-12-15

Completion date

2017-04-18

Last updated

2017-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease

Brief summary

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

Interventions

DEVICENovaTears®

Topical eye drops for lubrication of the ocular surface

DEVICEHydrabak®

Eye drops

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Tear film thickness as measured with high resolution optical coherence tomography	4 weeks

Secondary

Measure	Time frame
Non-invasive tear break up time	4 weeks
Dynamic Meibomian Gland Imaging	4 weeks
Blink frequency	4 weeks
Symptom VAS	4 weeks
Lipid layer thickness	4 weeks
Conjunctival lissamine green staining	4 weeks
Schirmer I test	4 weeks
Tear film break up time	4 weeks
Ocular surface disease index	4 weeks
Corneal fluorescein staining	4 weeks

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026