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

NCT01864330 | Completed Phase 4 DMC

• 1 other identifier: OPHT-28102012
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Dry Eye Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Tear film thickness

  Change in tear film thickness as measured with OCT. Total time frame is 4 hours

  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 (5)

• Tear Break Up Time

  change from screening to the last OCT measurement

• Subjective evaluation of ocular comfort

  change after instillation and after the last OCT measurement

• Schirmer I test

  change from screening to after the last OCT measurement

• Visual Acuity

  change from screening to after the last OCT measurement

• Intraocular Pressure

  change from screening to after the last OCT measurement

Study Arms (3)

Dry Eye Syndrome I

EXPERIMENTAL

20 patients with moderate dry eye syndrome

Device: Thealoz Duo®

Dry Eye Syndrome II

ACTIVE COMPARATOR

20 patients with moderate dry eye syndrome

Device: Hyabak®

Dry Eye Syndrome III

ACTIVE COMPARATOR

20 patients with moderate dry eye syndrome

Device: Hydrabak®

Interventions

Thealoz Duo® DEVICE

Eye Drops

Dry Eye Syndrome I

Hyabak® DEVICE

Eye Drops

Dry Eye Syndrome II

Hydrabak® DEVICE

Eye Drops

Dry Eye Syndrome III

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Gerhard Garhoefer, MD

  Department of Clinical Pharmacology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. PD Dr.

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 29, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 27, 2013

Record last verified: 2013-11

Locations

AU (1)