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

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03161080
• Other study ID #: OPHT-250716
• Status: Completed
• Phase: N/A
• Start date: February 9, 2017
• Est. completion date: May 12, 2017

Study information

• Verified date: August 2019
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 12, 2017
• Est. primary completion date: May 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Device:
• Neovis Total Multi® Eye Drops
Eye Drops containing Sodium hyaluronate (0.18%), lipoic acid, hydroxypropyl methylcellulose
• Vismed Multi® Eye Drops
Eye Drops containing Sodium hyaluronate (0.18%), potassium chloride, disodium phosphate
• Hydrabak® Eye Drops
Eye Drops containing sodium chloride (0,9%), sodium dihydrogen phosphate dehydrate

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Tear Break Up Time (TBUT)	Tear Break Up Time measured at screening visit and on study day	2 weeks
Secondary	Visual Analogue Scale (VAS)	Visual Analogue Scale about dry eye symptoms at screening visit and on study day	2 weeks
Secondary	Schirmer I test	Schirmer I test measured at screening visit and on study	2 weeks
Secondary	Ocular Surface Disease Index (OSDI) score	Ocular Surface Disease Index (OSDI) score assessed with questionnaire at screening visit	1 day
Secondary	Corneal fluorescein staining	Corneal fluorescein staining at screening visit and on study day	2 weeks
Secondary	Visual acuity	Visual acuity assessed at screening visit and on study day	2 weeks
Secondary	Intraocular pressure (IOP)	Intraocular pressure measured at screening visit	1 day