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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Device: Neovis Total Multi® Eye Drops; Device: Vismed Multi® Eye Drops; Device: Hydrabak® Eye Drops

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Department of Clinical Pharmacology, Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

Patients will be eligible for inclusion if all these criteria are respected:

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

Exclusion Criteria

Patients will be excluded under the following circumstances:

1. Participation in a clinical trial in the 3 weeks preceding the study
2. Symptoms of a clinically relevant illness in the 3 weeks before the first study day
3. Presence or history of a severe medical condition as judged by the clinical investigator
4. Intake of parasympathomimetic or anti-psychotic drugs
5. Wearing of contact lenses
6. Glaucoma in the medical history
7. Treatment with corticosteroids in the 4 weeks preceding the study
8. Topical treatment with any ophthalmic drug except topical lubricants in the 4 weeks preceding the study
9. Ocular infection or clinically significant inflammation not related to dry eye syndrome
10. Ocular surgery in the 3 months preceding the study
11. Sjögren's syndrome
12. Stevens-Johnson syndrome
13. History of allergic conjunctivitis
14. Pregnancy, planned pregnancy or lactating
15. Known hypersensitivity to any component of the study medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry Eye Neovis; 20 Patients with dry eye syndrome receiving Neovis Total Multi Eyedrops	Device: Neovis Total Multi® Eye Drops; Eye Drops containing Sodium hyaluronate (0.18%), lipoic acid, hydroxypropyl methylcellulose
Experimental: Dry Eye Vismed; 20 Patients with dry eye syndrome receiving Vismed Multi Eyedrops	Device: Vismed Multi® Eye Drops; Eye Drops containing Sodium hyaluronate (0.18%), potassium chloride, disodium phosphate
Experimental: Dry Eye Hydrabak; 20 Patients with dry eye syndrome receiving Hydrabak Eyedrops	Device: Hydrabak® Eye Drops; Eye Drops containing sodium chloride (0,9%), sodium dihydrogen phosphate dehydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lipid layer thickness	Change in lipid layer thickness measured with the LipiViewII Ocular Surface Interferometer at predose and at defined time points after instillation of eyedrops	1 day
Tear Break Up Time (TBUT)	Tear Break Up Time measured at screening visit and on study day	2 weeks
Visual Analogue Scale (VAS)	Visual Analogue Scale about dry eye symptoms at screening visit and on study day	2 weeks
Schirmer I test	Schirmer I test measured at screening visit and on study	2 weeks
Ocular Surface Disease Index (OSDI) score	Ocular Surface Disease Index (OSDI) score assessed with questionnaire at screening visit	1 day
Corneal fluorescein staining	Corneal fluorescein staining at screening visit and on study day	2 weeks
Visual acuity	Visual acuity assessed at screening visit and on study day	2 weeks
Intraocular pressure (IOP)	Intraocular pressure measured at screening visit	1 day

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2017
• Primary Completion (Actual): May 12, 2017
• Study Completion (Actual): May 12, 2017

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: OPHT-250716

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No