Influence of Lachrymal Substitute Gels on Tear Film Thickness in Patients With Moderate to Severe Dry Eye Syndrome

Dry Eye Syndromes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585453
• Other study ID #: LT2258-PIV-0614
• Status: Completed
• Phase: Phase 4
• First received: April 26, 2015
• Last updated: December 2, 2015
• Start date: April 2015
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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, exact information about the tear film thickness and 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 ultra high resolution optical coherence tomography (OCT) has become available. The aim of the present study is to assess tear film thickness and corneal residence time of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Hylo® Gel Eye Drops and Systane® Gel Eye Drops in patients with moderate to severe 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Men and women aged over 18 years

2. Signed and dated written informed consent

3. History of dry eye syndrome for at least 3 months

4. Tear Break Up Time (BUT) = 10 seconds or Schirmer I test = 5 mm and = 2mm

5. OSDI = 22

6. Normal ophthalmic findings except dry eye syndrome, ametropia < 6 Dpt.

7. No administration of topical lubricants 12-24 hours before the screening examination

Exclusion Criteria:

1. Presence of an ocular pathology judged by the investigator as incompatible with the study.

2. Any other clinical relevant ocular abnormality except DES.

3. History of allergy, known hypersensitivity to one of the components: the study medications or Fluorescein.

4. History of known clinically relevant allergy.

5. Medical or surgical history judged by the investigator to be incompatible with the study participation (hepatic or renal insufficiency; all chronic severe organic disease: metabolic, endocrine, neoplastic, haematological disease; severe psychiatric illness, etc.).

6. History of a recent acute illness with a recovery period within the 2 weeks before the inclusion visit (Day 0).

7. Pregnancy, lactation.

8. Pre-menopausal woman who is not using a reliable birth control method (oral contraceptives or coil) or is not surgically sterilised.

9. Participation in any high-speed or water-sports during the study without ocular protection (goggles or glasses).

10. Subject unable to understand the study instructions or unlikely to comply with the study schedule and treatment.

11. Participation in another clinical study in the 4 weeks before the start of the present study or at the same time as the present study.

12. Subject is a ward of court.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• Thealoz Duo Gel
Manufacturer: Laboratoires Thea, France
• Hylo-Gel
Manufacturer: Ursapharm, Saarbrücken, Germany
• Systane Gel Drops
Manufacturer: Alcon Pharma GmbH, Fort Worth, TX, USA

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	Tear Film thickness as measured with optical coherence tomography (OCT)		360 minutes	No
Secondary	Tear Break Up Time		1 month	No
Secondary	Schirmer 1 test		1 month	No
Secondary	Subjective evaluation of ocular comfort		1 month	No