Contact Lens DiscomfortPhase 2NCT05548491
Safety, Tolerability and Pharmacodynamics of AZR-MD-001 in Contact Lens Discomfort (CLD)
A Phase 2 study testing AZR-MD-001 ointment/semi-solid drug in people with Contact Lens Discomfort, run by Azura Ophthalmics at 2 sites in Australia.
Trial summary
A two stage, multi-center, vehicle-controlled study to determine common symptoms in patients with Contact Lens Discomfort (CLD) in Stage 1 and to evaluate the safety, tolerability, and pharmacodynamics of AZR-MD-001 in Stage 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Discomfort
- What is being tested?
- AZR-MD-001 ointment/semi-solid drug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 2 sitesAustralia
- Study dates
- 10 Nov 2022to 13 Oct 2023
- 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
- Evidence of meibomian gland obstruction (based on a meibomian gland secretion (MGS) score of ≤12 for 15 glands of the lower lid) in both eyes.
- A history of wearing soft contact lenses for at least 6 months.
- Screening CLDEQ-8 score >12
Who cannot join
- Active ocular infection (bacterial, viral, or fungal).
- Participant is unlikely to follow study instructions or to complete all required study visit(s) or has a condition or situation that in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.
- Participant is an employee at the investigational site or is related to any member of the study staff.
- Participation in another clinical trial involving a therapeutic drug or device within the past 30 days
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
University of New South Wales, School of Optometry and Vision Science
Sydney, New South Wales
Ophthalmic Trials Australia
Teneriffe, Queensland
About this study
Official title: A Two Stage, Multi-center, Vehicle-controlled, Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZR-MD-001 and to Determine Common Symptoms in Contact Lens Discomfort (CLD)
A two stage, multi-center, vehicle-controlled study to determine common symptoms in patients with Contact Lens Discomfort (CLD) in Stage 1 and to evaluate the safety, tolerability, and pharmacodynamics of AZR-MD-001 in Stage 2.
Read the detailed description
A two stage, multi-center, vehicle-controlled study to determine common symptoms in patients with Contact Lens Discomfort (CLD) in Stage 1 and to evaluate the safety, tolerability, and pharmacodynamics of AZR-MD-001 in Stage 2.
For Stage 1 of the study, up to 12 participants who experience symptoms of CLD and experience concomitant meibomian gland dysfunction will complete a Screening visit followed by a hybrid concept elicitation and cognitive debriefing interview which can occur at the end of the Screening visit or up to 14 days later.
Stage 2 is a multi-center, single-masked, vehicle-controlled, randomized, parallel group study. Participants with CLD will be randomly assigned in a 1:1 ratio to receive either active AZR-MD-001 ointment/semi-solid drug (1.0%) or AZR-MD-001 vehicle for 3 months.
- Conditions
- Contact Lens Discomfort
- Being tested
- AZR-MD-001 ointment/semi-solid drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZR-MD-001 ointment/semi-solid drugDrug
ointment/semi-solid drug
| Study group | Role | What they receive |
|---|---|---|
| AZR-MD-001 1.0% | Experimental | AZR-MD-001 ointment/semi-solid drug (1.0%) Receives: Drug: AZR-MD-001 ointment/semi-solid drug |
| AZR-MD-001 vehicle | Placebo comparator | AZR-MD-001 vehicle Receives: Drug: AZR-MD-001 ointment/semi-solid drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meibomian Glands Yielding Liquid Secretion (MGYLS) Yielding Liquid Secretion (MGYLS)
Change from baseline to month 3 in the number of Meibomian Glands Yielding Liquid Secretion (MGYLS)
Measured: 3 months
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) fluctuating vision
Change from baseline to month 3 in CLDEQ-8 fluctuating vision items. Scores can range from 0 (normal) to 9 (impacted vision).
(summed responses to questions 3a and 3b only)
Measured: 3 months
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score
Change from baseline to month 3 in CLDEQ-8 total score. Scores can range from 0 (normal) to 37 (Impacted Contact Use).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start10 Nov 2022
- Primary completion13 Oct 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Lens DiscomfortStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azura Ophthalmics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548491
- Sponsor's protocol ID
- AZ202201
- Status last verified
- Oct 2023
- First submitted
- 17 Sep 2022
- Last updated
- 18 Oct 2023
- 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 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Stage, Multi-center, Vehicle-controlled, Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZR-MD-001 and to Determine Common Symptoms in Contact Lens Discomfort (CLD)
- ClinicalTrials.gov ID
- NCT05548491
- Acronym / sponsor ID
- AZ202201
- Conditions
- Contact Lens Discomfort
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Azura OphthalmicsIndustry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 21 Sep 2022 (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.
A two stage, multi-center, vehicle-controlled study to determine common symptoms in patients with Contact Lens Discomfort (CLD) in Stage 1 and to evaluate the safety, tolerability, and pharmacodynamics of AZR-MD-001 in Stage 2.
Detailed description
A two stage, multi-center, vehicle-controlled study to determine common symptoms in patients with Contact Lens Discomfort (CLD) in Stage 1 and to evaluate the safety, tolerability, and pharmacodynamics of AZR-MD-001 in Stage 2.
For Stage 1 of the study, up to 12 participants who experience symptoms of CLD and experience concomitant meibomian gland dysfunction will complete a Screening visit followed by a hybrid concept elicitation and cognitive debriefing interview which can occur at the end of the Screening visit or up to 14 days later.
Stage 2 is a multi-center, single-masked, vehicle-controlled, randomized, parallel group study. Participants with CLD will be randomly assigned in a 1:1 ratio to receive either active AZR-MD-001 ointment/semi-solid drug (1.0%) or AZR-MD-001 vehicle for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZR-MD-001 1.0% | Experimental | Drug: AZR-MD-001 ointment/semi-solid drugAZR-MD-001 ointment/semi-solid drug (1.0%) |
| AZR-MD-001 vehicle | Placebo comparator | Drug: AZR-MD-001 ointment/semi-solid drugAZR-MD-001 vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Evidence of meibomian gland obstruction (based on a meibomian gland secretion (MGS) score of ≤12 for 15 glands of the lower lid) in both eyes.
- A history of wearing soft contact lenses for at least 6 months.
- Screening CLDEQ-8 score >12
Key exclusion criteria (4 listed)
- Active ocular infection (bacterial, viral, or fungal).
- Participant is unlikely to follow study instructions or to complete all required study visit(s) or has a condition or situation that in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.
- Participant is an employee at the investigational site or is related to any member of the study staff.
- Participation in another clinical trial involving a therapeutic drug or device within the past 30 days
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-001 ointment/semi-solid drugointment/semi-solid drug | Drug | AZR-MD-001 1.0%, AZR-MD-001 vehicle |
Primary outcome
Meibomian Glands Yielding Liquid Secretion (MGYLS) Yielding Liquid Secretion (MGYLS)
Time frame: 3 months
Change from baseline to month 3 in the number of Meibomian Glands Yielding Liquid Secretion (MGYLS)
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) fluctuating vision
Time frame: 3 months
Change from baseline to month 3 in CLDEQ-8 fluctuating vision items. Scores can range from 0 (normal) to 9 (impacted vision). (summed responses to questions 3a and 3b only)
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score
Time frame: 3 months
Change from baseline to month 3 in CLDEQ-8 total score. Scores can range from 0 (normal) to 37 (Impacted Contact Use).
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 18 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Contact Lens Discomfort
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
Dry Eye Disease (DED), Contact Lens Discomfort (CLD)
Not yet recruitingPhase 4
Contact Lens-Wearing Dry Eye Subjects Who Are Treated With Acoltremon 0.003%
Dry Eye, Contact Lens Discomfort
Active, not recruiting
Meibomian Gland Dysfunction Management
Contact Lens Discomfort, Meibomian Gland Dysfunction
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZR-MD-001 ointment/semi-solid drug in people with Contact Lens Discomfort, run by Azura Ophthalmics at 2 sites in Australia.
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: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. 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?
Meibomian Glands Yielding Liquid Secretion (MGYLS) Yielding Liquid Secretion (MGYLS) (time frame: 3 months). The study lists 3 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 18 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.