Back to resultsAdded Benefits of Lachrymal Substitute Gel During the Night in Patients With Moderate to Severe Dry Eye Syndrome
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Thealoz Duo Gel and Thealoz Duo eye drops
Thealoz Duo eye drops
Sponsored by
About this trial
This is an interventional basic science trial for Dry Eye Syndromes
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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, neoplastic, hematological disease; severe psychiatric illness, etc.).
- History of a recent acute illness with a recovery period within the 2 weeks before the inclusion visit (Day 0).
- 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.
Sites / Locations
- Department of Clinical Pharmacology, Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patients with dry eye syndrome 1
Patients with dry eye syndrome 2
Arm Description
20 patients with dry eye syndrome, they will receive intervention 1 for one week and then cross over to intervention 2
20 patients with dry eye syndrome, they will receive intervention 2 for one week and then cross over to intervention 1
Outcomes
Primary Outcome Measures
Patient satisfaction when awakening (VAS)
Secondary Outcome Measures
Quality of life
Number of drops of Thealoz Duo instilled during the day (patient diary)
Tear break up time
Conjunctival and corneal staining
Schirmer 1 Test
OSDI questionnaire
Ocular Surface Disease Index Questionnaire
Full Information
NCT ID
NCT02585648
First Posted
April 26, 2015
Last Updated
March 22, 2017
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT02585648
Brief Title
Added Benefits of Lachrymal Substitute Gel During the Night in Patients With Moderate to Severe Dry Eye Syndrome
Official Title
Added Benefits of Lachrymal Substitute Gel During the Night in Patients With Moderate to Severe Dry Eye Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with dry eye syndrome 1
Arm Type
Experimental
Arm Description
20 patients with dry eye syndrome, they will receive intervention 1 for one week and then cross over to intervention 2
Arm Title
Patients with dry eye syndrome 2
Arm Type
Experimental
Arm Description
20 patients with dry eye syndrome, they will receive intervention 2 for one week and then cross over to intervention 1
Intervention Type
Device
Intervention Name(s)
Thealoz Duo Gel and Thealoz Duo eye drops
Other Intervention Name(s)
Intervention 1
Intervention Description
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
Intervention Name(s)
Thealoz Duo eye drops
Other Intervention Name(s)
Intervention 2
Intervention Description
Thealoz Duo eye drops during the day (4 to 6 drops per day)
Primary Outcome Measure Information:
Title
Patient satisfaction when awakening (VAS)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
4 weeks
Title
Number of drops of Thealoz Duo instilled during the day (patient diary)
Time Frame
4 weeks
Title
Tear break up time
Time Frame
4 weeks
Title
Conjunctival and corneal staining
Time Frame
4 weeks
Title
Schirmer 1 Test
Time Frame
4 weeks
Title
OSDI questionnaire
Description
Ocular Surface Disease Index Questionnaire
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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, neoplastic, hematological disease; severe psychiatric illness, etc.).
History of a recent acute illness with a recovery period within the 2 weeks before the inclusion visit (Day 0).
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.
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Added Benefits of Lachrymal Substitute Gel During the Night in Patients With Moderate to Severe Dry Eye Syndrome
We'll reach out to this number within 24 hrs