Dry EyePhase 3MELODY-1NCT05201170
A Phase 3, Multi-Center Study Evaluating PL9643 in Patients with Dry Eye
A Phase 3 study testing PL9643 Ophthalmic Solution in people with Dry Eye and Dry Eye Syndromes, run by Palatin Technologies, Inc at 18 sites in United States.
Trial summary
This is a multi-center, double-masked, randomized, vehicle-controlled study testing PL9643, an ophthalmic solution to determine if safe and efficacious for dry eye patients. After a 2-week run-in period, patients will be randomized equally to the PL9643 ophthalmic solution or vehicle ophthalmic solution administered… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Dry Eye Syndromes
- What is being tested?
- PL9643 Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 575 participants
- Where
- 18 sitesUnited States
- Study dates
- 30 Dec 2021to 21 Nov 2023
- 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;
- Provide written informed consent;
- Be willing and able to comply with all study procedures;
- Have a patient-reported history of dry eye for at least 5 years prior to Visit 1;
- Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;
- Have a best corrected visual acuity (BCVA) of 0.7 logarithm of the minimum angle of resolution (logMAR) or better (Snellen equivalent score of 20/100 or better) in each eye at Visit 1;
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- Have an inferior fluorescein corneal staining score > 1 at both Visits 1 and 2 Pre-CAE®;
- Have an Eye Discomfort from the Visual Analog Scale (VAS) ≥25 at both Visits 1 and 2 Pre-CAE®;
- Report a score of ≥ 2 according to the Ora Calibra® Ocular Discomfort \& 4-Symptom Questionnaire in at least one of the dry eye symptoms at Visits 1 and 2 Pre-CAE®;
- Have a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2;
- Have a corneal fluorescein staining score of ≥ 2 in any corneal region (inferior, central or superior) according to the Ora Calibra® Corneal and Conjunctival Staining Scale for Grading of Fluorescein Staining in at least one eye at Visits 1 and 2 Pre-CAE®;
- Have a conjunctival redness score ≥ 1 according to the Ora Calibra® Conjunctival Redness for Dry Eye Scale in at least one eye at Visits 1 and 2 Pre-CAE®;
- Demonstrate in the same eye(s) a response to the CAE®at Visits 1 and 2 as defined by:
- Having at least a ≥1 point increase in fluorescein staining in the inferior region in at least one eye following CAE® exposure;
- Reporting an Ocular Discomfort score ≥3 at 2 or more consecutive time points in at least one eye during CAE® exposure (if a subject has an Ocular Discomfort rating of 3 at time = 0 for an eye, s/he must report an Ocular Discomfort rating of 4 for two consecutive measurements for that eye). Note: a subject cannot have an Ocular Discomfort score of 4 at time = 0);
- Have at least one eye, the same eye, satisfy all criteria for 7, 8, 9, 10, 11, 12 and 13 above;
- A negative urine pregnancy test if female of childbearing potential (those who are not surgically sterilized [bilateral tubal ligation, hysterectomy or bilateral oophorectomy] or post-menopausal [12 months after last menses]) and must use adequate birth control through the study period. For non-sexually active females, abstinence may be regarded as an adequate method of birth control
Who cannot join
- Have any clinically significant slit-lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the Investigator may interfere with study parameters;
- Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1 or Visit 2;
- Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
- Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
- Have used Restasis®, Xiidra®, Cequa®, or Eysuvis® within 60 days of Visit 1;
- Have had any ocular and/or lid surgeries in the past 6 months or have any planned ocular and/or lid surgeries over the study period;
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- Have had any laser procedures (e.g. YAG capsulotomy) in the past 3 months;
- Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;
- Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study); the respective wash-out periods are required for thefollowing medications:
- Ocular, oral or nasal antihistamines: 72 hours prior to Visit 1 and during the study.
- Oral aspirin or aspirin-containing products allowed if dose has been stable over past 30 days prior to Visit 1 and no change in dose is anticipated during the study period
- Corticosteroids or mast cell stabilizers (including ocular): 14 days prior to Visit 1
- Any medication (oral or topical) known to cause ocular drying that has not been administered as a stable dose for at least 30 days prior to Visit 1 and during the study
- All other topical ophthalmic preparations (including artificial tear substitutes) other than the study drops: 72 hours prior to Visit 1
- Have an uncontrolled systemic disease;
- Be a woman who is pregnant, nursing, or planning a pregnancy;
- Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 6 (or early termination visit) if of childbearing potential. Non-childbearing potential is defined as a woman who is permanently sterilized (e.g., bilateral tubal ligation, hysterectomy or bilateral oophorectomy), or is post-menopausal (without menses for 12 consecutive months);
- 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; intrauterine device; 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;
- 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;
- Have used an investigational drug or device within 30 days of Visit 1 unless the Investigator or Sponsor deems a washout period of up to 60 days is required;
- Participated in a previous clinical study involving PL9643;
- Be unable or unwilling to follow instructions, including participation in all study assessments and visits.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Andover Eye Associates
Andover, Massachusetts, 01810
Austin Clinical Research
Austin, Texas, 78750
Pankratz Eye Institute
Columbus, Indiana, 47203
Axis Clinical
Dallas, Texas, 75243
Erie Retina Research, LLC
Erie, Pennsylvania, 16507
Bergstrom Eye research, LLC
Fargo, North Dakota, 58103
Global Research Management
Glendale, California, 91204
Advancing Vision Research
Goodlettsville, Tennessee, 37072
Michael Washburn Center for Ophthalmic Research, LLC
Indianapolis, Indiana, 46240
Center for Sight
Las Vegas, Nevada, 89052
Kentucky Eye Institute
Lexington, Kentucky, 40517
Butchertown Clinical Trials
Louisville, Kentucky, 40206
Total Eye Care, PA
Memphis, Tennessee, 38119
Mint Hill
Mint Hill, North Carolina, 28227
Eye Research Foundation
Newport Beach, California, 92663
Core, Inc
Shelby, North Carolina, 28150
Advancing Vision Research
Smyrna, Tennessee, 37167
East West Eye Institute
Torrance, California, 90505
About this study
Official title: A Phase 3, Multi-center, Randomized, Double-Masked and Vehicle-Controlled Study Evaluating the Efficacy and Safety of the Melanocortin, PL9643 Ophthalmic Solution, Compared to Vehicle in Subjects with Dry Eye
This is a multi-center, double-masked, randomized, vehicle-controlled study testing PL9643, an ophthalmic solution to determine if safe and efficacious for dry eye patients.
After a 2-week run-in period, patients will be randomized equally to the PL9643 ophthalmic solution or vehicle ophthalmic solution administered bilaterally three times a day for 12 weeks.
A Data Monitoring Committee was engaged to review interim data.
Read the detailed description
This is a multi-center, double-masked, randomized, vehicle-controlled study testing PL9643, an ophthalmic solution, to determine the safety and efficacy against a vehicle in dry eye patients.
During a 2-week/14-day study run-in period (for the purpose of subject selection) prior to randomization, all subjects will receive Vehicle Ophthalmic Solution (vehicle) bilaterally three times a day. Randomization will then occur in a 1:1 ratio where patients will be assigned to receive PL9643 ophthalmic solution given bilaterally three times a day or vehicle ophthalmic solution administered bilaterally three times a day. The treatment period is 12 weeks.
- Conditions
- Dry Eye, Dry Eye Syndromes
- Being tested
- Vehicle Ophthalmic Solution, PL9643 Ophthalmic Solution
- Keywords
- Dry eye, Ophthalmology, Eye diseases, Corneal diseases, Conjunctival diseases, Ophthalmic Solutions, Pharmaceutical Solutions
- Medical subject headings
- Dry Eye Syndromes, Eye Diseases, Corneal Diseases, Conjunctival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vehicle Ophthalmic SolutionDrug
Also called Control
Ophthalmic Solution
PL9643 Ophthalmic SolutionDrug
Also called Active study medication
Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| PL9643 Ophthalmic Solution | Experimental | PL9643 ophthalmic solution bilaterally three times a day. Receives: Drug: PL9643 Ophthalmic Solution |
| Vehicle Ophthalmic Solution | Active comparator | Vehicle ophthalmic solution bilaterally three times a day. Receives: Drug: Vehicle Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conjunctival Sum Lissamine Green Staining
Measured by the Ora Calibra® Scale. Change from Baseline to week 12.
Measured: Visit 6 (Day 85), Change from Pre-CAE to Post-CAE
Ocular Pain
As Measured by Visual Analog Scale (VAS). PL9643 versus Vehicle, in hyper-responder sub-population. Hyper-responder sub-population is defined as those patients achieving a VAS score of 4 or greater within the first 30 minutes of being challenged in the CAE® (clinical symptom) at Visit 2.
Measured: Change from Pre-CAE to Post-CAE at Visit 6 (Day 85)
Secondary outcomes (10)
Nasal Lissamine Green Staining in Study Eye
As measured by Ora Calibra Scale at Visit 6 (Day 85) in Study Eye
Measured: Change from Baseline to Visit 6 (Day 85), Pre-CAE
Tear Film Break-Up Time (TFBUT) in Study Eye
Change from Baseline Post-CAE® to Week 12 Post-CAE®
Measured: Change from Baseline to Visit 6 (Day 85), Post-CAE
Total Sum Lissamine Green Staining in Study Eye
As measured by Ora Calibra Scale at Visit 6 (Day 85) in Study Eye
Measured: Change from Baseline Pre-CAE® to Week 12 Pre-CAE
Ocular Pain for ITT
As Measured by Visual Analog Scale at Visit 6 (Day 85), PL9643 versus Vehicle, In ITT population
Measured: Visit 6 (Day 85), Change from Pre-CAE to Post-CAE
Inferior Fluorescein Staining in Study Eye
As Measured by Ora Calibra Scale at Visit 6 (Day 85) in Study Eye
Measured: Change from Baseline to Visit 6 (Day 85), Post-CAE
Inferior Corneal Fluorescein Staining in Study Eye
As measured by Ora Calibra Scale at Visit 6 (Day 85) in Study Eye
Measured: Change from Baseline to Visit 6 (Day 85), Pre-CAE
Foreign Body Sensation for Hyper-Responders
As Measured by Visual Analog Scale at Visit 6 (Day 85) for Hyper-Responders
Measured: Visit 6 (Day 85), Change from Pre-CAE to Post-CAE
Eye Dryness for Hyper-Responders versus Vehicle in hyper-responder sub-population
As Measured by Visual Analog Scale at Visit 6 (Day 85) for Hyper-Responders
Measured: Change from Baseline to Visit 6 (Day 85), Post-CAE
Unanesthetized Schirmer Test Result (mm) in Study Eye
Measured at Visit 6 (Day 85) in Study Eye
Measured: Change from Baseline to Visit 6 (Day 85), Pre-CAE
Eye Discomfort for Hyper-responders versus Vehicle in hyper-responder sub-population
As Measured by Visual Analog Scale at Visit 6 (Day 85) for Hyper-responders
Measured: Change from Baseline to Visit 6 (Day 85), Post-CAE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start30 Dec 2021
- Primary completion1 Sep 2023
- Study completion21 Nov 2023
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized 1:1 to either the PL9643 treatment group or to the vehicle control group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 575 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palatin Technologies, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Dodge, Study director, Palatin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201170
- Sponsor's protocol ID
- PL9643-301
- Acronym
- MELODY-1
- Status last verified
- Jan 2022
- First submitted
- 8 Jan 2022
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-center, Randomized, Double-Masked and Vehicle-Controlled Study Evaluating the Efficacy and Safety of the Melanocortin, PL9643 Ophthalmic Solution, Compared to Vehicle in Subjects with Dry Eye
- ClinicalTrials.gov ID
- NCT05201170
- Acronym / sponsor ID
- MELODY-1 / PL9643-301
- Conditions
- Dry Eye, Dry Eye Syndromes
- Keywords
- Dry eye, Ophthalmology, Eye diseases, Corneal diseases, Conjunctival diseases, Ophthalmic Solutions, Pharmaceutical Solutions
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 575 participants (actual)
- Lead sponsor
- Palatin Technologies, IncIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 21 Nov 2023 (actual)
- First posted
- 21 Jan 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.
This is a multi-center, double-masked, randomized, vehicle-controlled study testing PL9643, an ophthalmic solution to determine if safe and efficacious for dry eye patients.
After a 2-week run-in period, patients will be randomized equally to the PL9643 ophthalmic solution or vehicle ophthalmic solution administered bilaterally three times a day for 12 weeks.
A Data Monitoring Committee was engaged to review interim data.
Detailed description
This is a multi-center, double-masked, randomized, vehicle-controlled study testing PL9643, an ophthalmic solution, to determine the safety and efficacy against a vehicle in dry eye patients.
During a 2-week/14-day study run-in period (for the purpose of subject selection) prior to randomization, all subjects will receive Vehicle Ophthalmic Solution (vehicle) bilaterally three times a day. Randomization will then occur in a 1:1 ratio where patients will be assigned to receive PL9643 ophthalmic solution given bilaterally three times a day or vehicle ophthalmic solution administered bilaterally three times a day. The treatment period is 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized 1:1 to either the PL9643 treatment group or to the vehicle control group.
| Arm | Type | Receives |
|---|---|---|
| PL9643 Ophthalmic Solution | Experimental | Drug: PL9643 Ophthalmic SolutionPL9643 ophthalmic solution bilaterally three times a day. |
| Vehicle Ophthalmic Solution | Active comparator | Drug: Vehicle Ophthalmic SolutionVehicle ophthalmic solution bilaterally three times a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Be at least 18 years of age;
- Provide written informed consent;
- Be willing and able to comply with all study procedures;
- Have a patient-reported history of dry eye for at least 5 years prior to Visit 1;
- Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;
Key exclusion criteria (23 listed)
- Have any clinically significant slit-lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the Investigator may interfere with study parameters;
- Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1 or Visit 2;
- Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
- Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
- Have used Restasis®, Xiidra®, Cequa®, or Eysuvis® within 60 days of Visit 1;
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 |
|---|---|---|
| Vehicle Ophthalmic SolutionAlso: ControlOphthalmic Solution | Drug | Vehicle Ophthalmic Solution |
| PL9643 Ophthalmic SolutionAlso: Active study medicationOphthalmic Solution | Drug | PL9643 Ophthalmic Solution |
Primary outcome
Conjunctival Sum Lissamine Green Staining
Time frame: Visit 6 (Day 85), Change from Pre-CAE to Post-CAE
Measured by the Ora Calibra® Scale. Change from Baseline to week 12.
Ocular Pain
Time frame: Change from Pre-CAE to Post-CAE at Visit 6 (Day 85)
As Measured by Visual Analog Scale (VAS). PL9643 versus Vehicle, in hyper-responder sub-population. Hyper-responder sub-population is defined as those patients achieving a VAS score of 4 or greater within the first 30 minutes of being challenged in the CAE® (clinical symptom) at Visit 2.
10 secondary outcomes
Nasal Lissamine Green Staining in Study Eye
Time frame: Change from Baseline to Visit 6 (Day 85), Pre-CAE
Tear Film Break-Up Time (TFBUT) in Study Eye
Time frame: Change from Baseline to Visit 6 (Day 85), Post-CAE
Total Sum Lissamine Green Staining in Study Eye
Time frame: Change from Baseline Pre-CAE® to Week 12 Pre-CAE
Ocular Pain for ITT
Time frame: Visit 6 (Day 85), Change from Pre-CAE to Post-CAE
Inferior Fluorescein Staining in Study Eye
Time frame: Change from Baseline to Visit 6 (Day 85), Post-CAE
Inferior Corneal Fluorescein Staining in Study Eye
Time frame: Change from Baseline to Visit 6 (Day 85), Pre-CAE
Foreign Body Sensation for Hyper-Responders
Time frame: Visit 6 (Day 85), Change from Pre-CAE to Post-CAE
Eye Dryness for Hyper-Responders versus Vehicle in hyper-responder sub-population
Time frame: Change from Baseline to Visit 6 (Day 85), Post-CAE
Unanesthetized Schirmer Test Result (mm) in Study Eye
Time frame: Change from Baseline to Visit 6 (Day 85), Pre-CAE
Eye Discomfort for Hyper-responders versus Vehicle in hyper-responder sub-population
Time frame: Change from Baseline to Visit 6 (Day 85), Post-CAE
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 17 Oct 2024.
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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.
Brian Dodge study director
Palatin
18 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 PL9643 Ophthalmic Solution in people with Dry Eye and Dry Eye Syndromes, run by Palatin Technologies, Inc at 18 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 17 inclusion and 23 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 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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. 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?
Conjunctival Sum Lissamine Green Staining (time frame: Visit 6 (Day 85), Change from Pre-CAE to Post-CAE). 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 17 Oct 2024.