Dry Eye SyndromePhase 3NCT01753596
Assessment of Tear Film Thickness by Optical Coherence Tomography in Healthy Subjects and Subjects With Dry Eye Disease
A Phase 3 study testing GENTEAL HA® Eye Drops (NOVARTIS, Switzerland) and Physiological Sodium Chloride solution (0,9%) in people with Dry Eye Syndrome, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Dry eye syndrome (DES) is a highly prevalent ocular condition with severe consequences for the patients reaching from ocular discomfort in its simplest form up to visual impairment and corneal ulceration in severe cases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- GENTEAL HA® Eye Drops (NOVARTIS, Switzerland) and Physiological Sodium Chloride solution (0,9%)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2014to Feb 2015
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged over 18 years
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropia < 6 Dpt
- Schirmer I test > 10 mm and BUT > 10 sec
- Men and women aged over 18 years
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant except DES
Show all 11Show fewer
- Normal ophthalmic findings, ametropia < 6 Dpt
- History of dry eye syndrome for at least 3 months
- Tear Break Up Time (BUT) < 10 seconds or Schirmer I test < 7 mm
- At least 2 symptoms of dry eye syndrome (foreign body sensation, burning, photophobia, blurred vision, pain, itching)
- Normal ophthalmic findings except dry eye syndrome
Who cannot join
- Regular use of medication (except contraceptives), abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Treatment in the previous 3 weeks with any drug
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Ametropia >= 6 Dpt
- Pregnancy
- Difference of more than 3 mm in Schirmer I test or difference of > 3 sec in BUT between the two eyes
- Known medical history of allergy, hypersensitivity or poor tolerance to any components of the medication or medical product used in the study
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, State of Vienna, 1090
About this study
Dry eye syndrome (DES) is a highly prevalent ocular condition with severe consequences for the patients reaching from ocular discomfort in its simplest form up to visual impairment and corneal ulceration in severe cases. Data from epidemiological studies indicate that DES is a common disease, especially in the elderly population, affecting up to 20% of adults aged 45 years or older. Topical lubricants are a mainstay of therapy, but data on its effect on tear film thickness and the corneal residence time are lacking.
Recently, a new objective method for assessment of tear film thickness by optical coherence tomography has been developed. The present study aims to investigate the corneal residence time of an established topical lubricant compared to placebo in patients with DES and healthy controls.
- Conditions
- Dry Eye Syndrome
- Being tested
- GENTEAL HA® Eye Drops (NOVARTIS, Switzerland), Physiological Sodium Chloride solution (0,9%)
- Keywords
- topical lubricants, tear film thickness, break up time, ocular surface disease index, 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.
GENTEAL HA® Eye Drops (NOVARTIS, Switzerland)Device
Physiological Sodium Chloride solution (0,9%)Other
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 30 healthy subjects | Experimental | Subjects will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo Receives: Device: GENTEAL HA® Eye Drops (NOVARTIS, Switzerland); Other: Physiological Sodium Chloride solution (0,9%) |
| 30 patients with dry eye syndrome | Experimental | Patients will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo Receives: Device: GENTEAL HA® Eye Drops (NOVARTIS, Switzerland); Other: Physiological Sodium Chloride solution (0,9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear film thickness
Measured: change from baseline to 1 hour after administration
Secondary outcomes (3)
Schirmer I Test
once on the study day
Measured: 1 day
Tear Break Up Time
once on the study day
Measured: 1 day
Ocular Surface Disease Index
once on the study day
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startDec 2014
- Primary completionDec 2014 (estimated)
- Study completionFeb 2015 (estimated)
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 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 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
- NCT01753596
- Sponsor's protocol ID
- OPHT-200612
- Status last verified
- Nov 2014
- First submitted
- 7 Dec 2012
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Tear Film Thickness by Optical Coherence Tomography in Healthy Subjects and Subjects With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT01753596
- Acronym / sponsor ID
- OPHT-200612
- Conditions
- Dry Eye Syndrome
- Keywords
- topical lubricants, tear film thickness, break up time, ocular surface disease index, Schirmer I test
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 20 Dec 2012 (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 (DES) is a highly prevalent ocular condition with severe consequences for the patients reaching from ocular discomfort in its simplest form up to visual impairment and corneal ulceration in severe cases. Data from epidemiological studies indicate that DES is a common disease, especially in the elderly population, affecting up to 20% of adults aged 45 years or older. Topical lubricants are a mainstay of therapy, but data on its effect on tear film thickness and the corneal residence time are lacking.
Recently, a new objective method for assessment of tear film thickness by optical coherence tomography has been developed. The present study aims to investigate the corneal residence time of an established topical lubricant compared to placebo in patients with DES and healthy controls.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 healthy subjects | Experimental | Device: GENTEAL HA® Eye Drops (NOVARTIS, Switzerland), Other: Physiological Sodium Chloride solution (0,9%)Subjects will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo |
| 30 patients with dry eye syndrome | Experimental | Device: GENTEAL HA® Eye Drops (NOVARTIS, Switzerland), Other: Physiological Sodium Chloride solution (0,9%)Patients will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men and women aged over 18 years
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropia < 6 Dpt
- Schirmer I test > 10 mm and BUT > 10 sec
- Men and women aged over 18 years
Key exclusion criteria (7 listed)
- Regular use of medication (except contraceptives), abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Treatment in the previous 3 weeks with any drug
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Ametropia >= 6 Dpt
- Pregnancy
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 |
|---|---|---|
| GENTEAL HA® Eye Drops (NOVARTIS, Switzerland) | Device | 30 healthy subjects, 30 patients with dry eye syndrome |
| Physiological Sodium Chloride solution (0,9%)Placebo | Other | 30 healthy subjects, 30 patients with dry eye syndrome |
Primary outcome
Tear film thickness
Time frame: change from baseline to 1 hour after administration
3 secondary outcomes
Schirmer I Test
Time frame: 1 day
Tear Break Up Time
Time frame: 1 day
Ocular Surface Disease Index
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
Related trials for Dry Eye Syndrome
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)
Not yet recruiting
LacriFill Canalicular Occlusion for Dry Eye After LASIK
Dry Eye Syndrome
Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
Not yet recruitingEarly Phase 1
a Novel siRNA Eyedrops for DED Treatment
Dry Eye
Recruiting
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
Dry Eye Disease
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 3 study testing GENTEAL HA® Eye Drops (NOVARTIS, Switzerland) and Physiological Sodium Chloride solution (0,9%) 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 11 inclusion and 7 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: withdrawn, as of the sponsor's last update on 14 Nov 2014. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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 from baseline to 1 hour after administration). 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 14 Nov 2014; AzTrials last refreshed its copy on 8 Nov 2026.