Keratoconjunctivitis SiccaPhase 3NCT02665234
A Safety and Efficacy Study of Tavilermide (MIM-D3) Ophthalmic Solution for the Treatment of Dry Eye Disease
A Phase 3 study testing 1% Tavilermide Ophthalmic Solution in people with Keratoconjunctivitis Sicca, run by Mimetogen Pharmaceuticals USA, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of Tavilermide Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconjunctivitis Sicca
- What is being tested?
- 1% Tavilermide Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Mar 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age.
- Provided written informed consent.
- Have a reported history of dry eye Have a history of use or desire to use eye drops for dry eye
Who cannot join
- Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) at Visit 1.
- Be diagnosed with ocular rosacea, or any viral or bacterial disease of the cornea or conjunctiva, within the last 12 months.
- Have any planned ocular and/or lid surgeries over the study period.
- Have corrected visual acuity greater than or equal to +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit .
- Have an uncontrolled systemic disease.
- Be a woman who is pregnant, nursing or planning a pregnancy.
Show all 10Show fewer
- Be a woman of childbearing potential who is not using an acceptable means of birth control
- Have a known allergy and/or sensitivity to the test article or its components.
- Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
- Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 45 days of Visit 1 Be unable or unwilling to follow instructions, including participation in all study assessments and visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Safety and Efficacy Study of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye Disease
The purpose of this study is to assess the safety and efficacy of Tavilermide Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye disease.
- Conditions
- Keratoconjunctivitis Sicca
- Being tested
- 1% Tavilermide Ophthalmic Solution, Placebo Ophthalmic Solution
- Keywords
- Dry Eye
- Medical subject headings
- Keratoconjunctivitis Sicca, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% Tavilermide Ophthalmic SolutionDrug
1% Tavilermide BID Dosing
Placebo Ophthalmic SolutionDrug
Vehicle Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| Tavilermide Ophthalmic Solution | Active comparator | 1% Tavilermide Ophthalmic Solution Receives: Drug: 1% Tavilermide Ophthalmic Solution |
| Vehicle Ophthalmic Solution | Placebo comparator | Placebo Ophthalmic Solution Receives: Drug: Placebo Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Corneal Fluorescein Staining Using The Ora Calibra Scale
An assessment of the total corneal fluorescein staining using the Ora Calibra Scale both immediately prior to and immediately following exposure to a challenge in a controlled adverse environment (CAE)
Measured: Day 57
Ocular Discomfort Using The Ora Calibra Scale
A patient-reported subjective assessment of ocular discomfort recorded at each of the 5 office visits throughout the treatment period
Measured: Day 57
Secondary outcomes (3)
Total Corneal Fluorescein Staining Using The Ora Calibra Scale
An assessment of the total corneal fluorescein staining using the Ora Calibra Scale both immediately prior to and immediately following exposure to a challenge in a controlled adverse environment (CAE)
Measured: Day 15
Ocular Surface Disease Index
Measured: Day 57
Ocular Dryness Using The Ora Calibra Scale
A patient-reported subjective assessment of ocular dryness recorded twice daily over the complete treatment period.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratoconjunctivitis SiccaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mimetogen Pharmaceuticals USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Garth Cumberlidge, PhD, Study director, Mimetogen Pharmaceuticals USA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665234
- Sponsor's protocol ID
- MIM-726
- Status last verified
- Aug 2019
- First submitted
- 20 Jan 2016
- Last updated
- 16 Aug 2019
- 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 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye Disease
- ClinicalTrials.gov ID
- NCT02665234
- Acronym / sponsor ID
- MIM-726
- Conditions
- Keratoconjunctivitis Sicca
- Keywords
- Dry Eye
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Mimetogen Pharmaceuticals USA, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 27 Jan 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 purpose of this study is to assess the safety and efficacy of Tavilermide Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tavilermide Ophthalmic Solution | Active comparator | Drug: 1% Tavilermide Ophthalmic Solution1% Tavilermide Ophthalmic Solution |
| Vehicle Ophthalmic Solution | Placebo comparator | Drug: Placebo Ophthalmic SolutionPlacebo Ophthalmic Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be at least 18 years of age.
- Provided written informed consent.
- Have a reported history of dry eye Have a history of use or desire to use eye drops for dry eye
Key exclusion criteria (10 listed)
- Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) at Visit 1.
- Be diagnosed with ocular rosacea, or any viral or bacterial disease of the cornea or conjunctiva, within the last 12 months.
- Have any planned ocular and/or lid surgeries over the study period.
- Have corrected visual acuity greater than or equal to +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit .
- Have an uncontrolled systemic disease.
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 |
|---|---|---|
| 1% Tavilermide Ophthalmic Solution1% Tavilermide BID Dosing | Drug | Tavilermide Ophthalmic Solution |
| Placebo Ophthalmic SolutionVehicle Ophthalmic Solution | Drug | Vehicle Ophthalmic Solution |
Primary outcome
Total Corneal Fluorescein Staining Using The Ora Calibra Scale
Time frame: Day 57
An assessment of the total corneal fluorescein staining using the Ora Calibra Scale both immediately prior to and immediately following exposure to a challenge in a controlled adverse environment (CAE)
Ocular Discomfort Using The Ora Calibra Scale
Time frame: Day 57
A patient-reported subjective assessment of ocular discomfort recorded at each of the 5 office visits throughout the treatment period
3 secondary outcomes
Total Corneal Fluorescein Staining Using The Ora Calibra Scale
Time frame: Day 15
Ocular Surface Disease Index
Time frame: Day 57
Ocular Dryness Using The Ora Calibra Scale
Time frame: 8 weeks
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 16 Aug 2019.
- 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.
Garth Cumberlidge, PhD study director
Mimetogen Pharmaceuticals USA, Inc.
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 1% Tavilermide Ophthalmic Solution in people with Keratoconjunctivitis Sicca, run by Mimetogen Pharmaceuticals USA, Inc. at 1 site in United States.
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 16 Aug 2019. 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 United States. 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. Some participants in this study may receive a placebo. 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 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?
Total Corneal Fluorescein Staining Using The Ora Calibra Scale (time frame: Day 57). 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 16 Aug 2019.