Dry Eye SyndromesPhase 4NCT02986750
Influence of Three Different Formulations of Lachrymal Substitutes on Tear Film Thickness and Other Signs and Symptoms in Patients With Moderate to Severe Dry Eye Syndrome
A Phase 4 study testing Thealoz Duo Eye Drops, Optive Eye Drops and Systane Ultra Eye Drops 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, Optive Eye Drops and Systane Ultra Eye Drops
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- 13 Feb 2016to 23 Mar 2017
- Phase
- Phase 4
- 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, ametropia < 6 Dpt.
- 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 study medications or Fluorescein.
- 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, haematological 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).
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- Pregnancy, lactation.
- Pre-menopausal woman who is not using a reliable birth control method (oral contraceptives or coil) or is not surgically sterilised.
- 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.
- Subject is a ward of court.
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. However, exact information about influence on tear film thickness and corneal residence time of topical lubricants is still sparse, therefore no ideal treatment regimen has been found.
Recently a new method for assessment of tear film thickness based on ultra-high resolution optical coherence tomography (OCT) has become available. The aim of the present study is to assess the influence on tear film thickness of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Optive® Eye Drops and Systane Ultra® Eye Drops in patients with moderate to severe dry eye disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test, corneal fluorescein staining and determination of tear break up time (BUT) will be performed to compare the product effects.
- Conditions
- Dry Eye Syndromes
- Being tested
- Thealoz Duo Eye Drops, Optive Eye Drops, Systane Ultra Eye Drops
- 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 DropsDevice
Manufacturer: Laboratoires Thea, France
Optive Eye DropsDevice
Manufacturer: Allergan Pharmaceuticals, Ireland
Systane Ultra Eye DropsDevice
Manufacturer: Alcon Pharma GmbH
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Patients with dry eye syndrome 1 | Experimental | 40 Patients with dry eye syndrome Receives: Device: Thealoz Duo Eye Drops |
| Experimental: Patients with dry eye syndrome 2 | Active comparator | 40 Patients with dry eye syndrome Receives: Device: Optive Eye Drops |
| Experimental: Patients with dry eye syndrome 3 | Active comparator | 40 Patients with dry eye syndrome Receives: Device: Systane Ultra Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tear film thickness as measured with Optical Coherence Tomography (OCT)
Tear film thickness as measured with Optical Coherence Tomography (OCT) predose and at defined time points after the first instillation, as well as on each study day
Measured: 10 weeks; at baseline, 10 minutes, 20 minutes, 40 minutes, 60 minutes, 120 minutes and 240 minutes after instillation of eye drops as well as 4 weeks and 8 weeks after the first instillation
Secondary outcomes (8)
Tear Break Up Time (BUT)
Measured: 10 weeks
Subjective evaluation of ocular comfort with questionnaire
Measured: 10 weeks
Schirmer I test
Measured: 10 weeks
OSDI score
Measured: 10 weeks
Corneal fluorescein staining (Oxford grading scale)
Measured: 10 weeks
Conjunctival hyperemia score
Measured: 10 weeks
Efficacy assessment of eye drops by the patient with questionnaire
Efficacy of eye drops will be performed by the patient by choosing one of the following options:
- Very satisfactory
- Satisfactory
- Not very satisfactory
- Unsatisfactory
Measured: 10 weeks
Efficacy assessment of eye drops by the investigator with questionnaire
Efficacy of eye drops will be performed by the investigator by choosing one of the following options:
- Very satisfactory
- Satisfactory
- Not very satisfactory
- Unsatisfactory
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study start13 Feb 2016
- Primary completion23 Mar 2017
- Study completion23 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 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
- NCT02986750
- Sponsor's protocol ID
- LT2258-PIV-0216
- Status last verified
- Aug 2019
- First submitted
- 1 Dec 2016
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Three Different Formulations of Lachrymal Substitutes on Tear Film Thickness and Other Signs and Symptoms in Patients With Moderate to Severe Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT02986750
- Acronym / sponsor ID
- LT2258-PIV-0216
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 13 Feb 2016 (actual)
- Primary completion
- 23 Mar 2017 (actual)
- Study completion
- 23 Mar 2017 (actual)
- First posted
- 8 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. However, exact information about influence on tear film thickness and corneal residence time of topical lubricants is still sparse, therefore no ideal treatment regimen has been found.
Recently a new method for assessment of tear film thickness based on ultra-high resolution optical coherence tomography (OCT) has become available. The aim of the present study is to assess the influence on tear film thickness of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Optive® Eye Drops and Systane Ultra® Eye Drops in patients with moderate to severe dry eye disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test, corneal fluorescein staining and determination of tear break up time (BUT) will be performed to compare the product effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Patients with dry eye syndrome 1 | Experimental | Device: Thealoz Duo Eye Drops40 Patients with dry eye syndrome |
| Experimental: Patients with dry eye syndrome 2 | Active comparator | Device: Optive Eye Drops40 Patients with dry eye syndrome |
| Experimental: Patients with dry eye syndrome 3 | Active comparator | Device: Systane Ultra Eye Drops40 Patients with dry eye syndrome |
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 (12 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 study medications or Fluorescein.
- 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, haematological 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 DropsManufacturer: Laboratoires Thea, France | Device | Experimental: Patients with dry eye syndrome 1 |
| Optive Eye DropsManufacturer: Allergan Pharmaceuticals, Ireland | Device | Experimental: Patients with dry eye syndrome 2 |
| Systane Ultra Eye DropsManufacturer: Alcon Pharma GmbH | Device | Experimental: Patients with dry eye syndrome 3 |
Primary outcome
Change in tear film thickness as measured with Optical Coherence Tomography (OCT)
Time frame: 10 weeks; at baseline, 10 minutes, 20 minutes, 40 minutes, 60 minutes, 120 minutes and 240 minutes after instillation of eye drops as well as 4 weeks and 8 weeks after the first instillation
Tear film thickness as measured with Optical Coherence Tomography (OCT) predose and at defined time points after the first instillation, as well as on each study day
8 secondary outcomes
Tear Break Up Time (BUT)
Time frame: 10 weeks
Subjective evaluation of ocular comfort with questionnaire
Time frame: 10 weeks
Schirmer I test
Time frame: 10 weeks
OSDI score
Time frame: 10 weeks
Corneal fluorescein staining (Oxford grading scale)
Time frame: 10 weeks
Conjunctival hyperemia score
Time frame: 10 weeks
Efficacy assessment of eye drops by the patient with questionnaire
Time frame: 10 weeks
Efficacy assessment of eye drops by the investigator with questionnaire
Time frame: 10 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 20 Aug 2019.
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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 Phase 4 study testing Thealoz Duo Eye Drops, Optive Eye Drops and Systane Ultra Eye Drops 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 12 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 20 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in tear film thickness as measured with Optical Coherence Tomography (OCT) (time frame: 10 weeks; at baseline, 10 minutes, 20 minutes, 40 minutes, 60 minutes, 120 minutes and 240 minutes after instillation of eye drops as well as 4 weeks and 8 weeks after the first instillation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2019.