Added Benefits of Lachrymal Substitute Gel During the Night in Patients With Moderate to Severe Dry Eye Syndrome

NCT ID: NCT02585648

Last Updated: 2017-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-11-30

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.

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.

Conditions

Dry Eye Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Patients with dry eye syndrome 1

20 patients with dry eye syndrome, they will receive intervention 1 for one week and then cross over to intervention 2

Group Type: EXPERIMENTAL

Thealoz Duo Gel and Thealoz Duo eye drops

Intervention Type: DEVICE

Thealoz Duo gel at night (1 drop before going to bed) + Thealoz Duo eye drops during the day (4 to 6 drops per day)

Thealoz Duo eye drops

Intervention Type: DEVICE

Thealoz Duo eye drops during the day (4 to 6 drops per day)

Patients with dry eye syndrome 2

20 patients with dry eye syndrome, they will receive intervention 2 for one week and then cross over to intervention 1

Group Type: EXPERIMENTAL

Thealoz Duo Gel and Thealoz Duo eye drops

Intervention Type: DEVICE

Thealoz Duo gel at night (1 drop before going to bed) + Thealoz Duo eye drops during the day (4 to 6 drops per day)

Thealoz Duo eye drops

Intervention Type: DEVICE

Thealoz Duo eye drops during the day (4 to 6 drops per day)

Interventions

Thealoz Duo Gel and Thealoz Duo eye drops

Thealoz Duo gel at night (1 drop before going to bed) + Thealoz Duo eye drops during the day (4 to 6 drops per day)

Intervention Type: DEVICE

Thealoz Duo eye drops

Thealoz Duo eye drops during the day (4 to 6 drops per day)

Intervention Type: DEVICE

Other Intervention Names

Intervention 1; Intervention 2

Eligibility Criteria

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, neoplastic, 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Gerhard Garhofer

Assoc. Prof. PD Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

LT2258-PIV-0215

Identifier Type: -

Identifier Source: org_study_id