Dry Eye SyndromesNCT02980913
Difference in the Frequency of Use of Lachrymal Substitutes in Patients With Moderate to Severe Dry Eye Syndrome
A study testing Thealoz Duo eye drops and Thealoz Duo gel and Thealoz Duo gel in people with Dry Eye Syndromes, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Thealoz Duo eye drops and Thealoz Duo gel and Thealoz Duo gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteAustria
- Study dates
- 11 Feb 2016to 17 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.).
- History of a recent acute illness with a recovery period within the 2 weeks before the inclusion visit (Day 0).
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
About this study
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
- Being tested
- Thealoz Duo eye drops and Thealoz Duo gel, Thealoz Duo gel
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thealoz Duo eye drops and Thealoz Duo gelDevice
Also called Intervention 1
Thealoz Duo eye drops during the day + Thealoz Duo gel at night (1 drop before going to bed) for 7 days
Thealoz Duo gelDevice
Also called Intervention 2
Thealoz Duo gel during the day and at night for 7 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Thealoz Duo eye drops and Thealoz Duo gel; Device: Thealoz Duo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 weeks
Secondary outcomes (5)
Tear Break Up Time (BUT)
Measured: 4 weeks
Schirmer I test
Measured: 4 weeks
Conjunctival and corneal staining
Measured: 4 weeks
OSDI questionnaire
Measured: 4 weeks
Quality of life of patients (VAS)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study start11 Feb 2016
- Primary completion17 May 2016
- Study completion17 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980913
- Sponsor's protocol ID
- LT 2258-PIV-05/15
- Status last verified
- Aug 2019
- First submitted
- 30 Nov 2016
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 30155282
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difference in the Frequency of Use of Lachrymal Substitutes in Patients With Moderate to Severe Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT02980913
- Acronym / sponsor ID
- LT 2258-PIV-05/15
- Conditions
- Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 11 Feb 2016 (actual)
- Primary completion
- 17 May 2016 (actual)
- Study completion
- 17 May 2016 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Patients with dry eye syndrome 1 | Experimental | Device: Thealoz Duo eye drops and Thealoz Duo gel, Device: Thealoz Duo gel20 patients with dry eye syndrome, they will receive intervention 1 for one week and then cross over to intervention 2 |
| Experimental: Patients with dry eye syndrome 2 | Experimental | Device: Thealoz Duo eye drops and Thealoz Duo gel, Device: Thealoz Duo gel20 patients with dry eye syndrome, they will receive intervention 2 for one week and then cross over to intervention 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thealoz Duo eye drops and Thealoz Duo gelAlso: Intervention 1Thealoz Duo eye drops during the day + Thealoz Duo gel at night (1 drop before going to bed) for 7 days | Device | Experimental: Patients with dry eye syndrome 1, Experimental: Patients with dry eye syndrome 2 |
| Thealoz Duo gelAlso: Intervention 2Thealoz Duo gel during the day and at night for 7 days | Device | Experimental: Patients with dry eye syndrome 1, Experimental: Patients with dry eye syndrome 2 |
Primary outcome
Number of drops of Thealoz Duo® eye drops and Thealoz Duo® gel instilled during the day (patient diary)
Time frame: 4 weeks
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)
5 secondary outcomes
Tear Break Up Time (BUT)
Time frame: 4 weeks
Schirmer I test
Time frame: 4 weeks
Conjunctival and corneal staining
Time frame: 4 weeks
OSDI questionnaire
Time frame: 4 weeks
Quality of life of patients (VAS)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Derived from this study: PubMed 30155282Fondi 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.
Related trials for Dry Eye Syndromes
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thealoz Duo eye drops and Thealoz Duo gel and Thealoz Duo gel in people with Dry Eye Syndromes, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of drops of Thealoz Duo® eye drops and Thealoz Duo® gel instilled during the day (patient diary) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02980913, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.