Difference in the Frequency of Use of Lachrymal Substitutes in Patients With Moderate to Severe Dry Eye Syndrome

Dry Eye Syndromes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02980913
• Other study ID #: LT 2258-PIV-05/15
• Status: Completed
• Phase: N/A
• Start date: February 11, 2016
• Est. completion date: May 17, 2016

Study information

• Verified date: August 2019
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• 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. Relief of symptoms in patients with moderate to severe dry eye disease is usually reached by the use of artificial tears during the day. Nighttime relief is often achieved by substances known to be more adhesive to the ocular surface, such as gels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 17, 2016
• Est. primary completion date: May 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• 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

7. No administration of topical lubricants 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 administered medical device product, fluorescein or lissamine green

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, neoplasic, hematological 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 sterilized.

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.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Device:
• Thealoz Duo eye drops and Thealoz Duo gel
Thealoz Duo eye drops during the day + Thealoz Duo gel at night (1 drop before going to bed) for 7 days
• Thealoz Duo gel
Thealoz Duo gel during the day and at night for 7 days

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	Number of drops of Thealoz Duo® eye drops and Thealoz Duo® gel instilled during the day (patient diary)	Number of drops of Thealoz Duo® eye drops and Thealoz Duo® gel instilled during the day during the observation period of one week for each medical device (patient diary)	4 weeks
Secondary	Tear Break Up Time (BUT)		4 weeks
Secondary	Schirmer I test		4 weeks
Secondary	Conjunctival and corneal staining		4 weeks
Secondary	OSDI questionnaire		4 weeks
Secondary	Quality of life of patients (VAS)		4 weeks