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

NCT02980913 | Completed

• 1 other identifier: LT 2258-PIV-05/15
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Tear Break Up Time (BUT)

  4 weeks

• Schirmer I test

  4 weeks

• Conjunctival and corneal staining

  4 weeks

• OSDI questionnaire

  4 weeks

• Quality of life of patients (VAS)

  4 weeks

Study Arms (2)

Experimental: Patients with dry eye syndrome 1

EXPERIMENTAL

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; Device: Thealoz Duo gel

Experimental: Patients with dry eye syndrome 2

EXPERIMENTAL

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; Device: Thealoz Duo gel

Interventions

Thealoz Duo eye drops and Thealoz Duo gel DEVICE

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

Also known as: Intervention 1

Experimental: Patients with dry eye syndrome 1; Experimental: Patients with dry eye syndrome 2

Thealoz Duo gel DEVICE

Thealoz Duo gel during the day and at night for 7 days

Also known as: Intervention 2

Experimental: Patients with dry eye syndrome 1; Experimental: Patients with dry eye syndrome 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged over 18 years
• Signed and dated written informed consent.
• History of dry eye syndrome for at least 3 months
• Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 5 mm and ≥ 2mm
• OSDI ≥ 22
• Normal ophthalmic findings except dry eye syndrome
• No administration of topical lubricants 24 hours before the screening examination

You may not qualify if:

• Presence of an ocular pathology judged by the investigator as incompatible with the study.
• Any other clinical relevant ocular abnormality except DES.
• History of allergy, known hypersensitivity to one of the components: the administered medical device product, fluorescein or lissamine green
• History of known clinically relevant allergy
• 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.).
• Pregnancy, lactation.
• Pre-menopausal woman who is not using a reliable birth control method (oral contraceptives or coil) or is not surgically sterilized.
• Participation in any high-speed or water-sports during the study without ocular protection (goggles or glasses).
• Subject unable to understand the study instructions or unlikely to comply with the study schedule and treatment.
• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• 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.

  PMID: 30155282 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. PD Dr.

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 2, 2016
• Study Start: February 11, 2016
• Primary Completion: May 17, 2016
• Study Completion: May 17, 2016
• Last Updated: August 22, 2019

Record last verified: 2019-08

Locations

AU (1)