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

NCT ID: NCT03161080

Last Updated: 2019-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-09
• Study Completion Date: 2017-05-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Dry Eye Neovis

20 Patients with dry eye syndrome receiving Neovis Total Multi Eyedrops

Group Type: EXPERIMENTAL

Neovis Total Multi® Eye Drops

Intervention Type: DEVICE

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

Dry Eye Vismed

20 Patients with dry eye syndrome receiving Vismed Multi Eyedrops

Group Type: EXPERIMENTAL

Vismed Multi® Eye Drops

Intervention Type: DEVICE

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

Dry Eye Hydrabak

20 Patients with dry eye syndrome receiving Hydrabak Eyedrops

Group Type: EXPERIMENTAL

Hydrabak® Eye Drops

Intervention Type: DEVICE

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

Interventions

Neovis Total Multi® Eye Drops

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

Intervention Type: DEVICE

Vismed Multi® Eye Drops

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

Intervention Type: DEVICE

Hydrabak® Eye Drops

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Gerhard Garhofer

Assoc. Prof. PD Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 30325687 (View on PubMed)

Other Identifiers

OPHT-250716

Identifier Type: -

Identifier Source: org_study_id