Dry Eye SyndromesREMOTOPNCT02908282
Topical Omega-3 Fatty Acids (REMOGEN® OMEGA) in the Treatment of Dry Eye
A study testing REMOGEN OMEGA and Povidone in people with Dry Eye Syndromes, run by TRB Chemedica AG at 5 sites in Germany.
Trial summary
The primary objective of this study is to evaluate the efficacy of REMOGEN® OMEGA in reducing Dry Eye Syndrome (DES) symptoms. Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- REMOGEN OMEGA and Povidone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 5 sitesGermany
- Study dates
- Oct 2016to Jul 2018
- 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 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient between 18 and 80 years of age and in good general health condition.
- Signed written informed consent.
- Existence of moderate to severe DES symptoms defined as Break-up time (TBUT) ≤ 10 s (mean of 3 consecutive measurements) and OSDI questionnaire ≥ 20.
Who cannot join
- Contraindication for the use of the products (e.g. hypersensitivity to the constituents of the test products) or any study procedure.
- Concomitant or previous participation in a clinical investigation within the last 3 months.
- Concomitant therapies/manipulations that affect either the tear film, tear secretion or ocular surface integrity or would alter the effect of the devices being evaluated.
- Concurrent (systemic) DES-associated diseases that are not on a stable therapy since at least 1 month (therapy not expected to change)
- Glaucoma that is not on a stable dosage since at least 2 weeks (therapy not expected to change)
- Any diseases or characteristics judged by the investigator to be incompatible with the assessments and/or procedures for the study evaluation
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- Pregnant or lactating females.
- Participants of childbearing age who do not use adequate methods of birth control.
- Subjects unable to understand the informed consent or having a high probability of noncompliance to the study procedures and/or non-completion of the study according to investigator's judgment (e.g. illiteracy, insufficient knowledge of local language).
- Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Dr. Flamm & Böker: Augenärzte am Tibarg
Hamburg, 22459
Praxis Dr. Kaercher
Heidelberg, Baden-Wurttemberg, 69121
Augenheilkunde Lindenthal
Köln-Lindenthal, North Rhine-Westphalia, 50931
Praxis Prof. Dr. Anselm Kampik & Kollegen
Munich, Bavaria, 80333
Augenzentrum Olching
Olching, Bavaria, 82140
About this study
The primary objective of this study is to evaluate the efficacy of REMOGEN® OMEGA in reducing Dry Eye Syndrome (DES) symptoms.
- Conditions
- Dry Eye Syndromes
- Being tested
- REMOGEN OMEGA, Povidone
- Keywords
- tear film, omega-3 fatty acids, 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.
REMOGEN OMEGADevice
Lubricant eye drops: preservative-free, hypotonic microemulsion of polyunsaturated fatty acids and hydrating polymers provided in single-dose containers of 0.25 ml.
PovidoneDevice
Artificial tears: preservative-free eye drops containing 2% povidone.
| Study group | Role | What they receive |
|---|---|---|
| PUFA (polyunsaturated fatty acids)-group | Other | REMOGEN OMEGA: Usage according to instructions for use. Receives: Device: REMOGEN OMEGA |
| C (control)-group | Other | Povidone: Usage according to instructions for use. Receives: Device: Povidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index (OSDI©) questionnaire
Measured: Week 4
Tear film stability
Tear film breakup time (unit: seconds)
Measured: Week 4
Secondary outcomes (9)
OSDI questionnaire
Measured: Day 0, Week 12
Tear film stability
Tear film breakup time (unit: seconds)
Measured: Day 0, Week 12
Visual acuity (best corrected)
Measured: Day 0, Week 4, Week 12
TearLab osmolarity test
Measured: Day 0, Week 4, Week 12
Inflammation marker matrix metalloproteinase 9 (MMP9)
Measured: Day 0, Week 4, Week 12
Lid-parallel conjunctival fold (LIPCOF) grading
Measured: Day 0, Week 4, Week 12
Corneal staining
Oxford grading scale
Measured: Day 0, Week 4, Week 12
Tear volume
Schirmer test
Measured: Day 0, Week 4, Week 12
Conjunctival staining
Oxford grading scale
Measured: Day 0, Week 4, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionJul 2018
- Study completionJul 2018
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- TRB Chemedica AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Kaercher, Dr., Principal investigator, Praxis Dr. Thomas Kaercher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908282
- Sponsor's protocol ID
- REMODES-DE-2015-12
- Acronym
- REMOTOP
- Status last verified
- Aug 2018
- First submitted
- 13 Sep 2016
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Omega-3 Fatty Acids (REMOGEN® OMEGA) in the Treatment of Dry Eye
- ClinicalTrials.gov ID
- NCT02908282
- Acronym / sponsor ID
- REMOTOP / REMODES-DE-2015-12
- Conditions
- Dry Eye Syndromes
- Keywords
- tear film, omega-3 fatty acids, eye drops
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- TRB Chemedica AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 20 Sep 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.
The primary objective of this study is to evaluate the efficacy of REMOGEN® OMEGA in reducing Dry Eye Syndrome (DES) symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PUFA (polyunsaturated fatty acids)-group | Other | Device: REMOGEN OMEGAREMOGEN OMEGA: Usage according to instructions for use. |
| C (control)-group | Other | Device: PovidonePovidone: Usage according to instructions for use. |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patient between 18 and 80 years of age and in good general health condition.
- Signed written informed consent.
- Existence of moderate to severe DES symptoms defined as Break-up time (TBUT) ≤ 10 s (mean of 3 consecutive measurements) and OSDI questionnaire ≥ 20.
Key exclusion criteria (10 listed)
- Contraindication for the use of the products (e.g. hypersensitivity to the constituents of the test products) or any study procedure.
- Concomitant or previous participation in a clinical investigation within the last 3 months.
- Concomitant therapies/manipulations that affect either the tear film, tear secretion or ocular surface integrity or would alter the effect of the devices being evaluated.
- Concurrent (systemic) DES-associated diseases that are not on a stable therapy since at least 1 month (therapy not expected to change)
- Glaucoma that is not on a stable dosage since at least 2 weeks (therapy not expected to change)
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 |
|---|---|---|
| REMOGEN OMEGALubricant eye drops: preservative-free, hypotonic microemulsion of polyunsaturated fatty acids and hydrating polymers provided in single-dose containers of 0.25 ml. | Device | PUFA (polyunsaturated fatty acids)-group |
| PovidoneArtificial tears: preservative-free eye drops containing 2% povidone. | Device | C (control)-group |
Primary outcome
Ocular Surface Disease Index (OSDI©) questionnaire
Time frame: Week 4
Tear film stability
Time frame: Week 4
Tear film breakup time (unit: seconds)
9 secondary outcomes
OSDI questionnaire
Time frame: Day 0, Week 12
Tear film stability
Time frame: Day 0, Week 12
Visual acuity (best corrected)
Time frame: Day 0, Week 4, Week 12
TearLab osmolarity test
Time frame: Day 0, Week 4, Week 12
Inflammation marker matrix metalloproteinase 9 (MMP9)
Time frame: Day 0, Week 4, Week 12
Lid-parallel conjunctival fold (LIPCOF) grading
Time frame: Day 0, Week 4, Week 12
Corneal staining
Time frame: Day 0, Week 4, Week 12
Tear volume
Time frame: Day 0, Week 4, Week 12
Conjunctival staining
Time frame: Day 0, Week 4, Week 12
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 15 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Thomas Kaercher, Dr. principal investigator
Praxis Dr. Thomas Kaercher
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REMOGEN OMEGA and Povidone in people with Dry Eye Syndromes, run by TRB Chemedica AG at 5 sites in Germany.
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 3 inclusion and 10 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 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. 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?
Ocular Surface Disease Index (OSDI©) questionnaire (time frame: Week 4). The study lists 2 primary outcomes in all. 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 15 Aug 2018.