Effect of Single Instillation of Three Different Topical Lubricants on Tear Film Thickness in Patients With Dry Eye Syndrome

NCT03161080 | Completed

• 1 other identifier: OPHT-250716
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence and incidence of dry eye syndrome (DES) is constantly increasing. Several therapeutic strategies have been proposed, but still no ideal regimen has been found. Recently, a new method for the non- invasive measurement of tear film thickness (TFT) based on optical coherence tomography (OCT) has been developed. It has been shown in previous studies that TFT correlates well with objective signs as well as with subjective symptoms of DES. In the present study the effects of three different topical lubricants (Neovis total multi®, Vismed multi® and Hydrabak® eye drops) on tear film thickness in patients with moderate to severe DES will be investigated using this device. Tear film thickness will be measured at baseline and at defined time points after single instillation. The course of tear film thickness during this study day will provide information about the corneal residency time of the three different eye drops. Patients with moderate to severe DES will be randomized to receive either Neovis total multi®, Vismed multi® or Hydrabak® eye drops. Assessment of lipid layer thickness of the tear film will be performed before and at pre-specified time points after instillation as secondary outcome. Other clinical measures for DES such as determination of tear film break up time (TFBUT), corneal fluorescein staining, Schirmer I test and subjective assessments will also be performed.

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• Change in tear film thickness

  Change in tear film thickness measured with optical coherence tomography (OCT) at predose and at defined time points after instillation of eyedrops

  1 day

Secondary Outcomes (8)

• Change in lipid layer thickness

  1 day

• Tear Break Up Time (TBUT)

  2 weeks

• Visual Analogue Scale (VAS)

  2 weeks

• Schirmer I test

  2 weeks

• Ocular Surface Disease Index (OSDI) score

  1 day

Study Arms (3)

Dry Eye Neovis

EXPERIMENTAL

20 Patients with dry eye syndrome receiving Neovis Total Multi Eyedrops

Device: Neovis Total Multi® Eye Drops

Dry Eye Vismed

EXPERIMENTAL

20 Patients with dry eye syndrome receiving Vismed Multi Eyedrops

Device: Vismed Multi® Eye Drops

Dry Eye Hydrabak

EXPERIMENTAL

20 Patients with dry eye syndrome receiving Hydrabak Eyedrops

Device: Hydrabak® Eye Drops

Interventions

Neovis Total Multi® Eye Drops DEVICE

Eye Drops containing Sodium hyaluronate (0.18%), lipoic acid, hydroxypropyl methylcellulose

Dry Eye Neovis

Vismed Multi® Eye Drops DEVICE

Eye Drops containing Sodium hyaluronate (0.18%), potassium chloride, disodium phosphate

Dry Eye Vismed

Hydrabak® Eye Drops DEVICE

Eye Drops containing sodium chloride (0,9%), sodium dihydrogen phosphate dehydrate

Dry Eye Hydrabak

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of at least 18 years
• Provides written informed consent prior to study-related procedures at the screening visit
• Is able to understand and willing to comply with the procedures and the actions asked of him/her
• History of dry eye syndrome for at least 3 months
• Reports at least 2 of the following symptoms related to dry eye syndrome: foreign body sensation, pain, itching, stinging, epiphora, photophobia or blurred vision
• Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 10 mm
• OSDI score ≥ 23 points
• Normal ophthalmic findings except dry eye syndrome

You may not qualify if:

• Patients will be excluded under the following circumstances:
• Participation in a clinical trial in the 3 weeks preceding the study
• Symptoms of a clinically relevant illness in the 3 weeks before the first study day
• Presence or history of a severe medical condition as judged by the clinical investigator
• Intake of parasympathomimetic or anti-psychotic drugs
• Wearing of contact lenses
• Glaucoma in the medical history
• Treatment with corticosteroids in the 4 weeks preceding the study
• Topical treatment with any ophthalmic drug except topical lubricants in the 4 weeks preceding the study
• Ocular infection or clinically significant inflammation not related to dry eye syndrome
• Ocular surgery in the 3 months preceding the study
• Sjögren's syndrome
• Stevens-Johnson syndrome
• History of allergic conjunctivitis
• Pregnancy, planned pregnancy or lactating

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• Szegedi S, Scheschy U, Schmidl D, Aranha Dos Santos V, Stegmann H, Adzhemian N, Fondi K, Bata AM, Werkmeister RM, Couderc C, Schmetterer L, Garhofer G. Effect of Single Instillation of Two Hyaluronic Acid-Based Topical Lubricants on Tear Film Thickness in Patients with Dry Eye Syndrome. J Ocul Pharmacol Ther. 2018 Nov;34(9):605-611. doi: 10.1089/jop.2018.0069. Epub 2018 Oct 16.

  PMID: 30325687 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. PD Dr.

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: May 19, 2017
• Study Start: February 9, 2017
• Primary Completion: May 12, 2017
• Study Completion: May 12, 2017
• Last Updated: August 22, 2019

Record last verified: 2019-08

Locations

AU (1)