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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Device: Thealoz Duo Gel and Thealoz Duo eye drops; Device: Thealoz Duo eye drops

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Department of Clinical Pharmacology, Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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); Other Names: Intervention 1; Device: Thealoz Duo eye drops; Thealoz Duo eye drops during the day (4 to 6 drops per day); Other Names: Intervention 2
Experimental: 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	Device: 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); Other Names: Intervention 1; Device: Thealoz Duo eye drops; Thealoz Duo eye drops during the day (4 to 6 drops per day); Other Names: Intervention 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient satisfaction when awakening (VAS)	4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: April 26, 2015
• First Submitted That Met QC Criteria: October 22, 2015
• First Posted (Estimate): October 23, 2015

Study Record Updates

• Last Update Posted (Actual): March 27, 2017
• Last Update Submitted That Met QC Criteria: March 22, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: LT2258-PIV-0215