Dry Eye DiseasePhase 3NCT06329791
A Phase 3 Study to Evaluate AZR-MD-001 in Patients with Abnormal Meibomian Gland Function and Dry Eye Disease (DED)
A Phase 3 study testing AZR-MD-001 in people with Dry Eye Disease, run by Azura Ophthalmics at 16 sites in United States.
Trial summary
This study is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study designed to evaluate the treatment of abnormal meibomian gland function and associated symptoms of DED using either AZR-MD-001 0.5% ophthalmic ointment or its vehicle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- AZR-MD-001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 16 sitesUnited States
- Study dates
- 28 May 2024to Nov 2025
- 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
- Male or female, 18 years of age or older at Screening.
- Evidence of active Evaporative DED at Screening and Baseline.
- Evidence of meibomian gland obstruction in both eyes at Screening and Baseline.
Who cannot join
- Ocular disease (except for Meibomian Gland Dysfunction (MGD) and DED/keratoconjunctivitis sicca) or systemic disease determined to be uncontrolled by the investigator.
- Patient has glaucoma, ocular hypertension, or an intraocular pressure (IOP) of ≥24 mm Hg in either eye at Screening.
- Recent (within the past 3 months of Screening) ocular surgery, trauma, herpes, or recurrent inflammation.
- Unwilling to abstain from the use of systemic or topical treatments for MGD or dry eye for the study duration.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
NC Eye Associates
Apex, North Carolina, 27502
Arizona Eye Center
Chandler, Arizona, 85225
Pankratz Eye Institute
Columbus, Indiana, 47203
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066
Oculus Research, Inc.
Garner, North Carolina, 27529
Global Research Management, Inc
Glendale, California, 91204
Advancing Vision Research (AVR) - Goodlettsville
Goodlettsville, Tennessee, 37072
The Eye Care Institute/Butchertown Clinical Trials
Louisville, Kentucky, 40206
Piedmont Eye Center
Lynchburg, Virginia, 24502
Total Eye Care
Memphis, Tennessee, 38119
Eye Research Foundation
Newport Beach, California, 92663
Wyse Eyecare
Northbrook, Illinois, 60062
CORE
Shelby, North Carolina, 28150
Advancing Vision Research (AVR) - Smyrna
Smyrna, Tennessee, 37167
Ophthalmology Associates
St Louis, Missouri, 63131
NVISION Clinical Research
Torrance, California, 90505
About this study
Official title: A Phase 3, Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Efficacy, Safety, and Tolerability of AZR-MD-001 in Patients with Abnormal Meibomian Gland Function and Associated Symptoms of Dry Eye Disease (DED)
This study is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study designed to evaluate the treatment of abnormal meibomian gland function and associated symptoms of DED using either AZR-MD-001 0.5% ophthalmic ointment or its vehicle. Study drug (either AZR-MD-001 or vehicle) will be dosed twice-weekly at bedtime for up to 12 months.
Read the detailed description
This study is designed to evaluate the treatment of abnormal meibomian gland function and associated symptoms of DED using either AZR-MD-001 0.5% ophthalmic ointment or its vehicle. Study drug (either AZR-MD-001 or vehicle) will be dosed twice-weekly at bedtime for up to 12 months.
Following a Screening qualification period, all patients diagnosed with abnormal meibomian gland function and associated symptoms of DED, and meeting the inclusion/exclusion criteria, will be randomized centrally, to treatment in a 1:1 ratio.
Study follow-up visits will be conducted on Day 14, Month 1.5, Month 3, Month 4.5, Month 6, Month 9, and Month 12. Patients will exit the study approximately 13 months after the Baseline visit. Any ongoing treatment-emergent adverse events (TEAEs) will be followed for an additional 30 days following the Month 12 visit.
- Conditions
- Dry Eye Disease
- Being tested
- AZR-MD-001, Vehicle
- 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.
AZR-MD-001Drug
Also called AZR-MD-001 ophthalmic ointment 0.5%
AZR-MD-001 sterile ophthalmic ointment 0.5%
VehicleOther
Also called AZR-MD-001 Vehicle
AZR-MD-001 Vehicle
| Study group | Role | What they receive |
|---|---|---|
| AZR-MD-001 | Experimental | AZR-MD-001 sterile ophthalmic ointment 0.5% to be administered twice weekly at bedtime. Receives: Drug: AZR-MD-001 |
| Vehicle | Placebo comparator | AZR-MD-001 Vehicle to be administered twice weekly at bedtime. Receives: Other: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Meibomian Glands Yielding Liquid Secretion
Meibomian Glands Yielding Liquid Secretion (MGYLS) measures the number of meibomian glands (0 - 15) secreting liquid
Measured: Month 3
Change from baseline in Total Ocular Surface Disease Index Score
The Total Ocular Surface Disease Index Score (OSDI) provides a score from 0 (normal) to 100 (abnormal)
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start28 May 2024
- Primary completionDec 2024 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azura Ophthalmics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
- Investigators
- Charles Bosworth, PhD, Study director, Azura Ophthalmics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329791
- Sponsor's protocol ID
- AZ202401
- Status last verified
- Jun 2024
- First submitted
- 19 Mar 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Efficacy, Safety, and Tolerability of AZR-MD-001 in Patients with Abnormal Meibomian Gland Function and Associated Symptoms of Dry Eye Disease (DED)
- ClinicalTrials.gov ID
- NCT06329791
- Acronym / sponsor ID
- AZ202401
- Conditions
- Dry Eye Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Azura OphthalmicsIndustry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- 28 May 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 26 Mar 2024 (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 multicenter, double-masked, vehicle-controlled, randomized, parallel group study designed to evaluate the treatment of abnormal meibomian gland function and associated symptoms of DED using either AZR-MD-001 0.5% ophthalmic ointment or its vehicle. Study drug (either AZR-MD-001 or vehicle) will be dosed twice-weekly at bedtime for up to 12 months.
Detailed description
This study is designed to evaluate the treatment of abnormal meibomian gland function and associated symptoms of DED using either AZR-MD-001 0.5% ophthalmic ointment or its vehicle. Study drug (either AZR-MD-001 or vehicle) will be dosed twice-weekly at bedtime for up to 12 months.
Following a Screening qualification period, all patients diagnosed with abnormal meibomian gland function and associated symptoms of DED, and meeting the inclusion/exclusion criteria, will be randomized centrally, to treatment in a 1:1 ratio.
Study follow-up visits will be conducted on Day 14, Month 1.5, Month 3, Month 4.5, Month 6, Month 9, and Month 12. Patients will exit the study approximately 13 months after the Baseline visit. Any ongoing treatment-emergent adverse events (TEAEs) will be followed for an additional 30 days following the Month 12 visit.
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 |
|---|---|---|
| AZR-MD-001 | Experimental | Drug: AZR-MD-001AZR-MD-001 sterile ophthalmic ointment 0.5% to be administered twice weekly at bedtime. |
| Vehicle | Placebo comparator | Other: VehicleAZR-MD-001 Vehicle to be administered twice weekly at bedtime. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, 18 years of age or older at Screening.
- Evidence of active Evaporative DED at Screening and Baseline.
- Evidence of meibomian gland obstruction in both eyes at Screening and Baseline.
Key exclusion criteria (4 listed)
- Ocular disease (except for Meibomian Gland Dysfunction (MGD) and DED/keratoconjunctivitis sicca) or systemic disease determined to be uncontrolled by the investigator.
- Patient has glaucoma, ocular hypertension, or an intraocular pressure (IOP) of ≥24 mm Hg in either eye at Screening.
- Recent (within the past 3 months of Screening) ocular surgery, trauma, herpes, or recurrent inflammation.
- Unwilling to abstain from the use of systemic or topical treatments for MGD or dry eye for the study duration.
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 |
|---|---|---|
| AZR-MD-001Also: AZR-MD-001 ophthalmic ointment 0.5%AZR-MD-001 sterile ophthalmic ointment 0.5% | Drug | AZR-MD-001 |
| VehicleAlso: AZR-MD-001 VehicleAZR-MD-001 Vehicle | Other | Vehicle |
Primary outcome
Change from baseline in Meibomian Glands Yielding Liquid Secretion
Time frame: Month 3
Meibomian Glands Yielding Liquid Secretion (MGYLS) measures the number of meibomian glands (0 - 15) secreting liquid
Change from baseline in Total Ocular Surface Disease Index Score
Time frame: Month 3
The Total Ocular Surface Disease Index Score (OSDI) provides a score from 0 (normal) to 100 (abnormal)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- 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.
Charles Bosworth, PhD study director
Azura Ophthalmics
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AZR-MD-001 in people with Dry Eye Disease, run by Azura Ophthalmics at 16 sites 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 4 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: status not confirmed, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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?
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?
Change from baseline in Meibomian Glands Yielding Liquid Secretion (time frame: Month 3). 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 27 Sep 2024.