CompletedNCT01864330Updated Nov 27, 2013

Influence of Lachrymal Substitutes on Tear Film Thickness in Patients With Moderate Dry Eye Syndrome

A Phase 4 interventional study of Thealoz Duo® and Hyabak® in Dry Eye Syndrome, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-27.

Sponsored by Medical University of Vienna · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the elderly population. Topically administered lubricants are the basis for treatment of this disease. However, information about the corneal residence time of topical lubricants is still sparse, therefore no ideal treatment regimen has been found.

Recently a new method for assessment of tear film thickness based on optical coherence tomography (OCT) has become available. The aim of the present study is to assess corneal residence time of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Hyabak® Eye Drops and Hydrabak® Eye Drops in patients with moderate dry eye disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test and determination of tear break up time (BUT) will be performed..

Conditions studied

Dry Eye Syndrome

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Keywords

topical lubricants
optical coherence tomography
tear break up time
Schirmer I test

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 192 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Men and women aged over 18 years
Signed and dated written informed consent.
History of dry eye syndrome for at least 3 months
Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 5 mm and ≥ 2mm
OSDI (Ocular Surface Disease Index) ≤ 32 and ≥ 13
Normal ophthalmic findings except dry eye syndrome, ametropia \< 6 Dpt.
No administration of topical lubricants 24 hours before the screening examination

Exclusion criteria

Exclusion Criteria:

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
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
Ocular surgery in the 3 months preceding the study
Sjögren's syndrome
Stevens-Johnson syndrome
History of allergic conjunctivitis
Ametropia >= 6 Dpt
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
Inability to understand the study procedures

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single group
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 60 participants (actual)

Study arms

Experimental
Dry Eye Syndrome I
20 patients with moderate dry eye syndrome
Device: Thealoz Duo®
Active comparator
Dry Eye Syndrome II
20 patients with moderate dry eye syndrome
Device: Hyabak®
Active comparator
Dry Eye Syndrome III
20 patients with moderate dry eye syndrome
Device: Hydrabak®

Interventions

DeviceThealoz Duo®
Eye Drops
DeviceHyabak®
Eye Drops
DeviceHydrabak®
Eye Drops

What researchers measure

Primary outcomes

Tear film thickness
Change in tear film thickness as measured with OCT. Total time frame is 4 hours
Time frame: Change in tear film thickness from predose to 10 ± 3 minutes, 20 ± 3 minutes, 40 ± 5 minutes, 60 ± 5 minutes, 120 ± 10 minutes and 240 ± 10 minutes after instillation

Secondary outcomes

Tear Break Up Time
Total time frame is 14 days
Time frame: change from screening to the last OCT measurement
Subjective evaluation of ocular comfort
Ocular comfort will be assessed immediately after instillation and at the end of the study day. Total time frame is 4 hours.
Time frame: change after instillation and after the last OCT measurement
Schirmer I test
Total time frame is 14 days
Time frame: change from screening to after the last OCT measurement
Visual Acuity
Total time frame is 14 days.
Time frame: change from screening to after the last OCT measurement
Intraocular Pressure
Total time frame is 14 days
Time frame: change from screening to after the last OCT measurement

Study locations

1 site

Department of Clinical Pharmacology
Vienna, 1090, Austria

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01864330
Lead sponsor: Medical University of Vienna
Responsible party: Gerhard Garhofer (Assoc. Prof. PD Dr., Medical University of Vienna) — Principal investigator
First posted: May 29, 2013
Start date: May 2013
Primary completion: Aug 2013
Completion: Sep 2013
Last update: Nov 27, 2013

Study contacts

Gerhard Garhoefer, MD

principal investigator · Department of Clinical Pharmacology, Medical University of Vienna

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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