Dry EyeNCT03517748
Evaluation of the Efficacy and Safety of DM05 Versus Optive™ on the Treatment of Moderate to Severe Ocular Dryness
A study testing DM05 eye drops and Optive™ eye drops in people with Dry Eye, run by Horus Pharma.
Trial summary
This study is a multicentric, comparative, randomized, investigator-blinded, in parallel groups study to demonstrate the non-inferiority of DM05 in comparison with Optive™, in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment. 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?
- DM05 eye drops and Optive™ eye drops
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 30 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sex: male or female.
- Age: more than 18 years.
- Subject with a dry eye syndrome needing artificial tears in the 3 months preceding the inclusion.
- Subject having used only artificial tears without preservative (NaCl 0.9%, Hydrabak®) during 1 or 2 weeks before inclusion (at 3 drops per day).
- Diagnosis of moderate to severe ocular dryness defined by a score OSDI (Ocular Surface Disease Index) ≥18.
- Subject with at least one eye with:
Show all 14Show fewer
- Global ocular staining (cornea and conjunctiva) ≥4 and ≤9 (Oxford scale from 0 to 15)
- AND one the following criteria:
- Schirmer test ≥ 3mm/5 min and ≤9mm/ 5 min OR
- Sum of 3 measurements of Tear film Break-Up Time (TBUT) ≤ 30s.
- Subject, having given freely and expressly his/her informed consent.
- Subject who is able to comply with the study requirements, as defined in the present protocol, at the Investigator's appreciation.
- In France: subject being affiliated to a health social security system.
- Female subjects of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end.
Who cannot join
- Pregnant or nursing woman or planning a pregnancy during the study.
- Subject deprived of freedom by administrative or legal decision.
- Subject in a social or sanitary establishment.
- Major subject who is under guardianship or who is not able to express his consent.
- Subject being in an exclusion period for a previous study.
- Subject suspected to be non-compliant according to the Investigator's judgment.
Show all 24Show fewer
- Subject wearing contact lenses during the study.
- Far best corrected visual acuity < 1/10
- Subject with severe ocular dryness with one of these conditions:
- Eyelid or blinking malfunction
- Corneal disorders not related to dry eye syndrome
- Ocular metaplasia
- Filamentous keratitis
- Corneal neovascularization
- Subject with severe meibomian gland dysfunction (MGD)
- Within the last 3 months prior to the inclusion, history of ocular trauma, infection or inflammation not related to dry eye syndrome.
- Within the last 12 months, history of ocular allergy or ocular herpes.
- Refractive or cataract surgery within the last 6 months.
- Any laser other than refractive surgery within the last 3 months.
- Any troubles of the ocular surface not related to dry eye syndrome.
- Ocular hypertension or glaucoma needing an hypotonic treatment
- Subject having used artificial tears in the 6 hours preceding the inclusion visit.
- Use during the month preceding the inclusion or during the study of: isotretinoïd, cyclosporine, tacrolimus, sirolimus, pimecrolimus, punctual plugs.
- Any not stabilized systemic treatment, which can have an effect on performance or safety criteria, at the investigator appreciation.
About this study
This study is a multicentric, comparative, randomized, investigator-blinded, in parallel groups study to demonstrate the non-inferiority of DM05 in comparison with Optive™, in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment.
Read the detailed description
Evaluation of the non-inferiority of DM05 in comparison with OptiveTM, in terms of cornea and conjunctiva staining (Oxford score), on worse eye, between D0 and D35.
- Comparison of D35 versus D0 and D84 versus D0 for each product and comparison between products for the following parameters:
- Evolution of cornea and conjunctiva staining (Oxford score) on worse eye.
- Evolution of OSDI score (Ocular Surface Disease Index).
- Evolution of Van Bijsterveld score (Lissamine green staining) in worse eye.
- Evolution of Schirmer test result in worse eye.
- Evolution of Tear film Break-Up Time (TBUT) in worse eye.
- Evolution of ocular dryness severity by evaluation of each main symptom by the patient and total score of all symptoms
- Evaluation of treatment performance by the investigator and the patient.
- Evaluation of the average frequency of use during 84 days for DM05 and OptiveTM.
Selection visit: D-14 to D-7
Wash-out period: 1 to 2 weeks with preservative-free 0.9% NaCl at 3 drops per day (Hydrabak®):
D0 : inclusion visit Follow-up visits: D35, D84
- Conditions
- Dry Eye
- Being tested
- DM05 eye drops, Optive™ 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.
DM05 eye dropsDevice
Ophthalmic use. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment.
Optive™ eye dropsDevice
Ophthalmic use. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment.
| Study group | Role | What they receive |
|---|---|---|
| the investigational device: DM05 | Experimental | DM05 eye drops, multidose sterile emulsion, will be administered in the DM05 Arm at one to two drops instilled in each eye from 4 to 6 times per day during 84 days Receives: Device: DM05 eye drops |
| The comparative device : Optive™ | Active comparator | Optive™ eye drops, multidose sterile solution, will be administered in the Optive Arm at one to two drops instilled in each eye from 4 to 6 times per day during 84 days Receives: Device: Optive™ eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the non-inferiority of DM05 in comparison with OptiveTM, in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment.
Assess the ocular surface fluorescein staining score- mean change from Baseline in the study at D35 in ocular surface fluorescein stainig score according to a scale from zero to 15
Measured: 35 days
Secondary outcomes (15)
To assess the total ocular surface fluorescein staining score at D84
Mean change from Baseline (D0) in the study eye and D84 in the total ocular surface fluoresceine staining score
Measured: 0 and 84 days
Evolution of DEQ-5 score
Evolution from Baseline of DEQ-5 questionnaire scores at day 35
Measured: 35 days
Evolution of DEQ-5 score
Evolution from Baseline of DEQ-5 questionnaire scores at day 84
Measured: 84 days
Evolution of Van Bijterveld score ( lissamine green staining)
Mean change from Baseline ( D0) and D 35 in the total Van Bijterveld score
Measured: 35 Days
Evolution of Van Bijterveld score ( lissamine green staining)
Mean change from Baseline ( D0) and D 84 in the total Van Bijterveld score
Measured: 84 days
Volume tear fluid secretion as assessed by schirmer test
Mean change from Baseline ( D0) in Volume tear fluid secretion as assessed by schirmer test, at day 35
Measured: 35 days
Volume tear fluid secretion as assessed by schirmer test
Mean change from Baseline ( D0) in Volume tear fluid secretion as assessed by schirmer test, at day 84
Measured: 84 days
Evolution of Tear film Break-Up Time
Mean change from Baseline (D0) in the study eye in TFBUT at Day 35
Measured: 35 days
Evolution of Tear film Break-Up Time
Mean change from Baseline (D0) in the study eye in TFBUT at Day 84
Measured: 84 days
Global sum score of dry eye symptoms at visit 3 - mean change from Baseline at visit 3 ( D35)
Mean change from Baseline in the global sum score of dry eye symptoms at D35 : discomfort,burning, stinging,eye dryness sensation, itching,foreign body sensation,photophobia, blurred vision.Each graded from 0 to 10
Measured: 35 days
Global sum score of dry eye symptoms at visit 4 - mean change from Baseline at visit 3 ( D84)
Mean change from Baseline in the global sum score of dry eye symptoms at D84 : discomfort,burning, stinging,eye dryness sensation, itching,foreign body sensation,photophobia, blurred vision.Each graded from 0 to 10
Measured: 84 days
Global treatment performance score assessed by the investigator at visit 3
Total Treatment performance score graded from 0 to 4
Measured: 35 days
Global treatment performance score assessed by the investigator at visit 4
Total Treatment performance score graded from 0 to 4
Measured: 84 days
Global treatment performance score assessed by the patient at visit 3
Total Treatment performance score graded from 0 to 4
Measured: 35 days
Global treatment performance score assessed by the patient at visit 4
Total Treatment performance score graded from 0 to 4
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start1 Dec 2016
- Primary completion2 Jan 2018
- Study completion30 Mar 2018
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
- Model description
- Because the comparator will be in commercial packaging, the blinding of the subject is not possible. However, the study will be blinded for the investigator: evaluations will be done by an independent investigator, different than the person who will distribute the product. Subjects will be identified by a patient number. Each patient number will be associated to a treatment number, according to a randomization list provided before the beginning of the clinical investigation, and randomized either in one of both treatment groups (DM05 or Optive®).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horus Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe Baudouin, Pr, Principal investigator, Hopital d Ophtalmologie des Quinze-vingts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517748
- Sponsor's protocol ID
- 15E1122
- Other IDs
- 2016-A01843-48
- Status last verified
- May 2018
- First submitted
- 24 Apr 2018
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depending on any journal publication of the results
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of DM05 Versus Optive™ on the Treatment of Moderate to Severe Ocular Dryness
- ClinicalTrials.gov ID
- NCT03517748
- Acronym / sponsor ID
- 15E1122
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Horus PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 2 Jan 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 7 May 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.
This study is a multicentric, comparative, randomized, investigator-blinded, in parallel groups study to demonstrate the non-inferiority of DM05 in comparison with Optive™, in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment.
Detailed description
Evaluation of the non-inferiority of DM05 in comparison with OptiveTM, in terms of cornea and conjunctiva staining (Oxford score), on worse eye, between D0 and D35.
- Comparison of D35 versus D0 and D84 versus D0 for each product and comparison between products for the following parameters:
- Evolution of cornea and conjunctiva staining (Oxford score) on worse eye.
- Evolution of OSDI score (Ocular Surface Disease Index).
- Evolution of Van Bijsterveld score (Lissamine green staining) in worse eye.
- Evolution of Schirmer test result in worse eye.
- Evolution of Tear film Break-Up Time (TBUT) in worse eye.
- Evolution of ocular dryness severity by evaluation of each main symptom by the patient and total score of all symptoms
- Evaluation of treatment performance by the investigator and the patient.
- Evaluation of the average frequency of use during 84 days for DM05 and OptiveTM.
Selection visit: D-14 to D-7
Wash-out period: 1 to 2 weeks with preservative-free 0.9% NaCl at 3 drops per day (Hydrabak®):
D0 : inclusion visit Follow-up visits: D35, D84
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Because the comparator will be in commercial packaging, the blinding of the subject is not possible. However, the study will be blinded for the investigator: evaluations will be done by an independent investigator, different than the person who will distribute the product. Subjects will be identified by a patient number. Each patient number will be associated to a treatment number, according to a randomization list provided before the beginning of the clinical investigation, and randomized either in one of both treatment groups (DM05 or Optive®).
| Arm | Type | Receives |
|---|---|---|
| the investigational device: DM05 | Experimental | Device: DM05 eye dropsDM05 eye drops, multidose sterile emulsion, will be administered in the DM05 Arm at one to two drops instilled in each eye from 4 to 6 times per day during 84 days |
| The comparative device : Optive™ | Active comparator | Device: Optive™ eye dropsOptive™ eye drops, multidose sterile solution, will be administered in the Optive Arm at one to two drops instilled in each eye from 4 to 6 times per day during 84 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Sex: male or female.
- Age: more than 18 years.
- Subject with a dry eye syndrome needing artificial tears in the 3 months preceding the inclusion.
- Subject having used only artificial tears without preservative (NaCl 0.9%, Hydrabak®) during 1 or 2 weeks before inclusion (at 3 drops per day).
- Diagnosis of moderate to severe ocular dryness defined by a score OSDI (Ocular Surface Disease Index) ≥18.
Key exclusion criteria (24 listed)
- Pregnant or nursing woman or planning a pregnancy during the study.
- Subject deprived of freedom by administrative or legal decision.
- Subject in a social or sanitary establishment.
- Major subject who is under guardianship or who is not able to express his consent.
- Subject being in an exclusion period for a previous study.
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 |
|---|---|---|
| DM05 eye dropsOphthalmic use. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment. | Device | the investigational device: DM05 |
| Optive™ eye dropsOphthalmic use. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment. | Device | The comparative device : Optive™ |
Primary outcome
Demonstrate the non-inferiority of DM05 in comparison with OptiveTM, in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment.
Time frame: 35 days
Assess the ocular surface fluorescein staining score- mean change from Baseline in the study at D35 in ocular surface fluorescein stainig score according to a scale from zero to 15
15 secondary outcomes
To assess the total ocular surface fluorescein staining score at D84
Time frame: 0 and 84 days
Evolution of DEQ-5 score
Time frame: 35 days
Evolution of DEQ-5 score
Time frame: 84 days
Evolution of Van Bijterveld score ( lissamine green staining)
Time frame: 35 Days
Evolution of Van Bijterveld score ( lissamine green staining)
Time frame: 84 days
Volume tear fluid secretion as assessed by schirmer test
Time frame: 35 days
Volume tear fluid secretion as assessed by schirmer test
Time frame: 84 days
Evolution of Tear film Break-Up Time
Time frame: 35 days
Evolution of Tear film Break-Up Time
Time frame: 84 days
Global sum score of dry eye symptoms at visit 3 - mean change from Baseline at visit 3 ( D35)
Time frame: 35 days
Global sum score of dry eye symptoms at visit 4 - mean change from Baseline at visit 3 ( D84)
Time frame: 84 days
Global treatment performance score assessed by the investigator at visit 3
Time frame: 35 days
Global treatment performance score assessed by the investigator at visit 4
Time frame: 84 days
Global treatment performance score assessed by the patient at visit 3
Time frame: 35 days
Global treatment performance score assessed by the patient at visit 4
Time frame: 84 days
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 7 May 2018.
- Individual participant dataSharing planned: Undecided. Depending on any journal publication of the results
Related trials for Dry Eye
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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, Pr principal investigator
Hopital d Ophtalmologie des Quinze-vingts
Questions about this trial
What is this clinical trial studying?
A study testing DM05 eye drops and Optive™ eye drops in people with Dry Eye, run by Horus Pharma.
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 14 inclusion and 24 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 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Demonstrate the non-inferiority of DM05 in comparison with OptiveTM, in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment. (time frame: 35 days). 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 7 May 2018.