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

Not Applicable

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Device: Thealoz Duo Gel and Thealoz Duo eye drops; Device: Thealoz Duo eye drops

• Registration Number: NCT02585648
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-26
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-23
• Study Start: 2016-02
• Primary Completion: 2016-05
• Study Completion: 2016-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Patients with dry eye syndrome 2	Thealoz Duo eye drops	20 patients with dry eye syndrome, they will receive intervention 2 for one week and then cross over to intervention 1
Patients with dry eye syndrome 1	Thealoz Duo eye drops	20 patients with dry eye syndrome, they will receive intervention 1 for one week and then cross over to intervention 2
Patients with dry eye syndrome 2	Thealoz Duo Gel and Thealoz Duo eye drops	20 patients with dry eye syndrome, they will receive intervention 2 for one week and then cross over to intervention 1
Patients with dry eye syndrome 1	Thealoz Duo Gel and Thealoz Duo eye drops	20 patients with dry eye syndrome, they will receive intervention 1 for one week and then cross over to intervention 2

Primary Outcome Measures

Name	Time	Method
Patient satisfaction when awakening (VAS)	4 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of life	4 weeks
Tear break up time	4 weeks
Conjunctival and corneal staining	4 weeks
OSDI questionnaire	4 weeks	Ocular Surface Disease Index Questionnaire
Schirmer 1 Test	4 weeks
Number of drops of Thealoz Duo instilled during the day (patient diary)	4 weeks

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria