Dry EyeNCT03460548
REMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye
A study testing Remogen and Cationorm in people with Dry Eye, run by TRB Chemedica at 1 site in France.
Trial summary
The efficacy and safety of Remogen® Omega in the treatment of dry eye signs and symptoms will be investigated in comparison to Cationorm®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Remogen and Cationorm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2018to 12 Jun 2019
- 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
- With at least a 3-month documented history of bilateral dry eye
- With a score of ocular surface staining with fluorescein (OSSF) ≥ 4 and ≤ 9 on the Oxford scale
- With at least one objective sign of tear deficiency
- With Ocular Surface Disease Index (OSDI) score of ≥ 18
Who cannot join
- Refractive surgery within 12 months prior to selection
- Any other ocular surgery or ocular trauma within 6 months prior to selection
- Systemic or local use of one of the following medications: glucocorticosteroids, cyclosporine A, antibiotics, NSAIDs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre Randomized Trial Comparing the Efficacy and Safety of REMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye
The efficacy and safety of Remogen® Omega in the treatment of dry eye signs and symptoms will be investigated in comparison to Cationorm®.
- Conditions
- Dry Eye
- Being tested
- Remogen, Cationorm
- 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.
RemogenDevice
instil 1 drop of the product in each eye, 4 times per day
CationormDevice
instil 1 drop of the product in each eye, 4 times per day
| Study group | Role | What they receive |
|---|---|---|
| Remogen | Experimental | Not described Receives: Device: Remogen |
| Cationorm | Active comparator | Not described Receives: Device: Cationorm |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSSF
Ocular surface staining with fluorescein (OSSF)
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start30 Mar 2018
- Primary completion16 Apr 2019
- Study completion12 Jun 2019
Why it stopped: low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- TRB Chemedica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe Baudouin, MD, PhD, Principal investigator, Quinze-Vingts Hospital, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460548
- Sponsor's protocol ID
- TOGA-CT-1501
- Status last verified
- Apr 2020
- First submitted
- 28 Feb 2018
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomized Trial Comparing the Efficacy and Safety of REMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye
- ClinicalTrials.gov ID
- NCT03460548
- Acronym / sponsor ID
- TOGA-CT-1501
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment rate
- Enrolment
- 26 participants (actual)
- Lead sponsor
- TRB ChemedicaIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 16 Apr 2019 (actual)
- Study completion
- 12 Jun 2019 (actual)
- First posted
- 9 Mar 2018 (actual)
- 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 efficacy and safety of Remogen® Omega in the treatment of dry eye signs and symptoms will be investigated in comparison to Cationorm®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remogen | Experimental | Device: Remogen |
| Cationorm | Active comparator | Device: Cationorm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- With at least a 3-month documented history of bilateral dry eye
- With a score of ocular surface staining with fluorescein (OSSF) ≥ 4 and ≤ 9 on the Oxford scale
- With at least one objective sign of tear deficiency
- With Ocular Surface Disease Index (OSDI) score of ≥ 18
Key exclusion criteria (3 listed)
- Refractive surgery within 12 months prior to selection
- Any other ocular surgery or ocular trauma within 6 months prior to selection
- Systemic or local use of one of the following medications: glucocorticosteroids, cyclosporine A, antibiotics, NSAIDs
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 |
|---|---|---|
| Remogeninstil 1 drop of the product in each eye, 4 times per day | Device | Remogen |
| Cationorminstil 1 drop of the product in each eye, 4 times per day | Device | Cationorm |
Primary outcome
OSSF
Time frame: Day 28
Ocular surface staining with fluorescein (OSSF)
Results and safety
The study was stopped early (reason given: low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- 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.
Christophe Baudouin, MD, PhD principal investigator
Quinze-Vingts Hospital, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remogen and Cationorm in people with Dry Eye, run by TRB Chemedica at 1 site in France.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 20 Apr 2020. 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 France. 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 was stopped early (reason given: low recruitment rate). Results are not available in the source record.
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?
OSSF (time frame: Day 28). 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 Apr 2020; AzTrials last refreshed its copy on 8 Nov 2026.