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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-15

Study Completion Date

2017-04-18

Brief Summary

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

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Detailed Description

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Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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NovaTears®

Group Type EXPERIMENTAL

NovaTears®

Intervention Type DEVICE

Topical eye drops for lubrication of the ocular surface

Hydrabak®

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

Group Type ACTIVE_COMPARATOR

Hydrabak®

Intervention Type DEVICE

Eye drops

Interventions

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NovaTears®

Topical eye drops for lubrication of the ocular surface

Intervention Type DEVICE

Hydrabak®

Eye drops

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No