Dry EyePhase 2NCT01257607
Safety and Efficacy Study of MIM-D3 Ophthalmic Solution for the Treatment of Dry Eye
A Phase 2 study testing MIM-D3 Ophthalmic Solution in people with Dry Eye, run by Mimetogen Pharmaceuticals USA, Inc. at 1 site in United States.
Trial summary
The objective of this study is to compare the safety and efficacy of 1% MIM-D3 and 5% MIM-D3 to placebo for the treatment of the signs and symptoms of dry eye. 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?
- MIM-D3 Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to May 2011
- Phase
- Phase 2
- 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
- Provide 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), or active ocular inflammation (e.g. follicular conjunctivitis) at Visit 1, or have been 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 1
- Have an uncontrolled systemic disease
- Be a woman who is pregnant, nursing or planning a pregnancy
- Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception include: hormonal - oral, implantable, injectable, or transdermal contraceptives; mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom; IUD; or surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use adequate birth control as defined above for the remainder of the study
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- 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 Phase 2, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of 1% MIM-D3 and 5% MIM-D3 Ophthalmic Solutions in the Environment, and During Challenge in the Controlled Adverse Environmental (CAE) Model
The objective of this study is to compare the safety and efficacy of 1% MIM-D3 and 5% MIM-D3 to placebo for the treatment of the signs and symptoms of dry eye.
- Conditions
- Dry Eye
- Being tested
- MIM-D3 Ophthalmic Solution, Placebo Ophthalmic Solution
- 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.
MIM-D3 Ophthalmic SolutionDrug
28 Days, BID
Placebo Ophthalmic SolutionDrug
28 Days, BID
| Study group | Role | What they receive |
|---|---|---|
| 1% MIM-D3 Ophthalmic Solution | Experimental | Not described Receives: Drug: MIM-D3 Ophthalmic Solution |
| 5% MIM-D3 Ophthalmic Solution | Experimental | Not described Receives: Drug: MIM-D3 Ophthalmic Solution |
| Placebo Ophthalmic Solution | Placebo comparator | Not described Receives: Drug: Placebo Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal staining
Ocular surface damage
Measured: 28 days
Secondary outcomes (3)
Tear film break-up time
Measured: 42 days
Conjunctival redness
Measured: 42 days
Tear osmolarity
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionMay 2011
- Study completionMay 2011
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mimetogen Pharmaceuticals USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gail Torkildsen, MD, Principal investigator, Andover Eye AssociatesJohn Lonsdale, MD, Principal investigator, Central Maine Eye Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257607
- Sponsor's protocol ID
- MIM-724
- Status last verified
- Aug 2019
- First submitted
- 7 Dec 2010
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of 1% MIM-D3 and 5% MIM-D3 Ophthalmic Solutions in the Environment, and During Challenge in the Controlled Adverse Environmental (CAE) Model
- ClinicalTrials.gov ID
- NCT01257607
- Acronym / sponsor ID
- MIM-724
- Conditions
- Dry Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Mimetogen Pharmaceuticals USA, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Dec 2010 (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 objective of this study is to compare the safety and efficacy of 1% MIM-D3 and 5% MIM-D3 to placebo for the treatment of the signs and symptoms of dry eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1% MIM-D3 Ophthalmic Solution | Experimental | Drug: MIM-D3 Ophthalmic Solution |
| 5% MIM-D3 Ophthalmic Solution | Experimental | Drug: MIM-D3 Ophthalmic Solution |
| Placebo Ophthalmic Solution | Placebo comparator | Drug: Placebo Ophthalmic Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be at least 18 years of age
- Provide 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), or active ocular inflammation (e.g. follicular conjunctivitis) at Visit 1, or have been 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 1
- Have an uncontrolled systemic disease
- Be a woman who is pregnant, nursing or planning a 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 |
|---|---|---|
| MIM-D3 Ophthalmic Solution28 Days, BID | Drug | 1% MIM-D3 Ophthalmic Solution, 5% MIM-D3 Ophthalmic Solution |
| Placebo Ophthalmic Solution28 Days, BID | Drug | Placebo Ophthalmic Solution |
Primary outcome
Corneal staining
Time frame: 28 days
Ocular surface damage
3 secondary outcomes
Tear film break-up time
Time frame: 42 days
Conjunctival redness
Time frame: 42 days
Tear osmolarity
Time frame: 42 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 19 Aug 2019.
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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.
Gail Torkildsen, MD principal investigator
Andover Eye Associates
John Lonsdale, MD principal investigator
Central Maine Eye Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MIM-D3 Ophthalmic Solution in people with Dry Eye, 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 4 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 19 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Corneal staining (time frame: 28 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 19 Aug 2019.