Dry Eye SyndromePhase 4NCT01864330
Influence of Lachrymal Substitutes on Tear Film Thickness in Patients With Moderate Dry Eye Syndrome
A Phase 4 study testing Thealoz Duo®, Hyabak® and Hydrabak® in people with Dry Eye Syndrome, 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 Syndrome
- What is being tested?
- Thealoz Duo®, Hyabak® and Hydrabak®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- May 2013to Sep 2013
- 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 (Ocular Surface Disease Index) ≤ 32 and ≥ 13
- Normal ophthalmic findings except dry eye syndrome, ametropia < 6 Dpt.
- No administration of topical lubricants 24 hours before the screening examination
Who cannot join
- Participation in a clinical trial in the 3 weeks preceding the study
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Presence or history of a severe medical condition as judged by the clinical investigator
- Intake of parasympathomimetic or anti-psychotic drugs
- Wearing of contact lenses
- Glaucoma
Show all 18Show fewer
- Treatment with corticosteroids in the 4 weeks preceding the study
- Topical treatment with any ophthalmic drug except topical lubricants in the 4 weeks preceding the study
- Ocular infection or clinically significant inflammation
- Ocular surgery in the 3 months preceding the study
- Sjögren's syndrome
- Stevens-Johnson syndrome
- History of allergic conjunctivitis
- Ametropia >= 6 Dpt
- Pregnancy, planned pregnancy or lactating
- Known hypersensitivity to any component of the study medication.
- Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease
- Inability to understand the study procedures
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology
Vienna, State of 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, information about the 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 optical coherence tomography (OCT) has become available. The aim of the present study is to assess corneal residence time of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Hyabak® Eye Drops and Hydrabak® Eye Drops in patients with moderate dry eye disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test and determination of tear break up time (BUT) will be performed..
- Conditions
- Dry Eye Syndrome
- Being tested
- Thealoz Duo®, Hyabak®, Hydrabak®
- Keywords
- topical lubricants, optical coherence tomography, tear break up time, Schirmer I test
- 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®Device
Eye Drops
Hyabak®Device
Eye Drops
Hydrabak®Device
Eye Drops
| Study group | Role | What they receive |
|---|---|---|
| Dry Eye Syndrome I | Experimental | 20 patients with moderate dry eye syndrome Receives: Device: Thealoz Duo® |
| Dry Eye Syndrome II | Active comparator | 20 patients with moderate dry eye syndrome Receives: Device: Hyabak® |
| Dry Eye Syndrome III | Active comparator | 20 patients with moderate dry eye syndrome Receives: Device: Hydrabak® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear film thickness
Change in tear film thickness as measured with OCT.
Total time frame is 4 hours
Measured: Change in tear film thickness from predose to 10 ± 3 minutes, 20 ± 3 minutes, 40 ± 5 minutes, 60 ± 5 minutes, 120 ± 10 minutes and 240 ± 10 minutes after instillation
Secondary outcomes (5)
Tear Break Up Time
Total time frame is 14 days
Measured: change from screening to the last OCT measurement
Subjective evaluation of ocular comfort
Ocular comfort will be assessed immediately after instillation and at the end of the study day.
Total time frame is 4 hours.
Measured: change after instillation and after the last OCT measurement
Schirmer I test
Total time frame is 14 days
Measured: change from screening to after the last OCT measurement
Visual Acuity
Total time frame is 14 days.
Measured: change from screening to after the last OCT measurement
Intraocular Pressure
Total time frame is 14 days
Measured: change from screening to after the last OCT measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 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
- Investigators
- Gerhard Garhoefer, MD, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864330
- Sponsor's protocol ID
- OPHT-28102012
- Status last verified
- Nov 2013
- First submitted
- 3 May 2013
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Lachrymal Substitutes on Tear Film Thickness in Patients With Moderate Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT01864330
- Acronym / sponsor ID
- OPHT-28102012
- Conditions
- Dry Eye Syndrome
- Keywords
- topical lubricants, optical coherence tomography, tear break up time, Schirmer I test
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 29 May 2013 (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, information about the 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 optical coherence tomography (OCT) has become available. The aim of the present study is to assess corneal residence time of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Hyabak® Eye Drops and Hydrabak® Eye Drops in patients with moderate dry eye disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test and determination of tear break up time (BUT) will be performed..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dry Eye Syndrome I | Experimental | Device: Thealoz Duo®20 patients with moderate dry eye syndrome |
| Dry Eye Syndrome II | Active comparator | Device: Hyabak®20 patients with moderate dry eye syndrome |
| Dry Eye Syndrome III | Active comparator | Device: Hydrabak®20 patients with moderate 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 (Ocular Surface Disease Index) ≤ 32 and ≥ 13
Key exclusion criteria (18 listed)
- Participation in a clinical trial in the 3 weeks preceding the study
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Presence or history of a severe medical condition as judged by the clinical investigator
- Intake of parasympathomimetic or anti-psychotic drugs
- Wearing of contact lenses
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 | Device | Dry Eye Syndrome I |
| Hyabak®Eye Drops | Device | Dry Eye Syndrome II |
| Hydrabak®Eye Drops | Device | Dry Eye Syndrome III |
Primary outcome
Tear film thickness
Time frame: Change in tear film thickness from predose to 10 ± 3 minutes, 20 ± 3 minutes, 40 ± 5 minutes, 60 ± 5 minutes, 120 ± 10 minutes and 240 ± 10 minutes after instillation
Change in tear film thickness as measured with OCT. Total time frame is 4 hours
5 secondary outcomes
Tear Break Up Time
Time frame: change from screening to the last OCT measurement
Subjective evaluation of ocular comfort
Time frame: change after instillation and after the last OCT measurement
Schirmer I test
Time frame: change from screening to after the last OCT measurement
Visual Acuity
Time frame: change from screening to after the last OCT measurement
Intraocular Pressure
Time frame: change from screening to after the last OCT measurement
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 27 Nov 2013.
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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.
Gerhard Garhoefer, MD principal investigator
Department of Clinical Pharmacology, Medical University of Vienna
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®, Hyabak® and Hydrabak® in people with Dry Eye Syndrome, 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 18 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 27 Nov 2013. 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?
Tear film thickness (time frame: Change in tear film thickness from predose to 10 ± 3 minutes, 20 ± 3 minutes, 40 ± 5 minutes, 60 ± 5 minutes, 120 ± 10 minutes and 240 ± 10 minutes after 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 27 Nov 2013.