Difference in the Frequency of Use of Lachrymal Substitutes 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 eye drops and Thealoz Duo gel; Device: Thealoz Duo gel

• 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, 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.

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: 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 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; Other Names: Intervention 1; Device: Thealoz Duo gel; Thealoz Duo gel during the day and at night for 7 days; Other Names: Intervention 2
Experimental: 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 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; Other Names: Intervention 1; Device: Thealoz Duo gel; Thealoz Duo gel during the day and at night for 7 days; Other Names: Intervention 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Schirmer I test	4 weeks
Conjunctival and corneal staining	4 weeks
Tear Break Up Time (BUT)	4 weeks
OSDI questionnaire	4 weeks
Quality of life of patients (VAS)	4 weeks

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Publications and helpful links

General Publications

• Fondi K, Wozniak PA, Schmidl D, Bata AM, Witkowska KJ, Popa-Cherecheanu A, Schmetterer L, Garhofer G. Effect of Hyaluronic Acid/Trehalose in Two Different Formulations on Signs and Symptoms in Patients with Moderate to Severe Dry Eye Disease. J Ophthalmol. 2018 Aug 1;2018:4691417. doi: 10.1155/2018/4691417. eCollection 2018.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2016
• Primary Completion (Actual): May 17, 2016
• Study Completion (Actual): May 17, 2016

Study Registration Dates

• First Submitted: November 30, 2016
• First Submitted That Met QC Criteria: November 30, 2016
• First Posted (Estimate): December 2, 2016

Study Record Updates

• Last Update Posted (Actual): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

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: LT 2258-PIV-05/15