Dry Eye DiseasePhase 2NCT04268069
Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye
A Phase 2 study testing PL9643 Ophthalmic Solution in people with Dry Eye Disease, run by ORA, Inc. at 4 sites in United States.
Trial summary
Evaluation of safety and efficacy of PL9643 Ophthalmic Solution compared 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 Disease
- What is being tested?
- PL9643 Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Feb 2020to 5 Oct 2020
- 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.
- 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 symptoms
- Have corrected visual acuity greater than or equal to +0.7 in both eyes
Who cannot join
- Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal)
- Have any planned ocular and/or lid surgeries over the study period.
- 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
- Have a known allergy and/or sensitivity to the test article or its components.
Show all 9Show fewer
- 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
- Be unable or unwilling to follow instructions, including participation in all study assessments and visits
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Andover Eye Associates
Andover, Massachusetts, 01810
Total Eye Care, P.A.
Memphis, Tennessee, 38119
Andover Eye Associates
Raynham, Massachusetts, 02767
Vita Eye Clinc
Shelby, North Carolina, 28150
About this study
Official title: A Phase 2, Multi-center, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of PL9643 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye
Evaluation of safety and efficacy of PL9643 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye.
Read the detailed description
The clinical trial is a Phase 2, multi center, randomized, double masked and placebo controlled study.
During a 14-day study run-in period (for the purpose of subject selection) prior to randomization, all subjects will receive Placebo Ophthalmic Solution (vehicle) bilaterally. During the screening period, exposure to the CAE® will be conducted to ascertain eligibility to enter the study at Visit 1 and Visit 2. Those who qualify at Visit 2 will be randomized to receive study drug in a double-masked fashion for 12 weeks. The CAE® exposure will occur at all Visits.
- Conditions
- Dry Eye Disease
- Being tested
- PL9643 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.
PL9643 Ophthalmic SolutionDrug
PL9643 Ophthalmic Solution as topical ophthalmic drops administered bilaterally for 12 weeks.
Placebo Ophthalmic SolutionDrug
Placebo solution as topical ophthalmic drops administered bilaterally for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Ophthalmic Solution (vehicle) | Placebo comparator | vehicle Receives: Drug: Placebo Ophthalmic Solution |
| PL9643 Ophthalmic Solution | Active comparator | PL9643 Ophthalmic Solution Receives: Drug: PL9643 Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inferior Corneal Fluorescein Staining Using The Ora Calibra Scale
An assessment of corneal fluorescein staining using the 0 [none] to 4 [worst] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
Measured: Day 85
Ocular Discomfort Using The Ora Calibra Scale
A patient-reported subjective assessment of ocular discomfort using the 0 [none] to 4 [worst] Ora Calibra Scale recorded at each study visit throughout the treatment period
Measured: Day 85
Secondary outcomes (3)
Corneal Fluorescein Staining Using The Ora Calibra Scale
An assessment of corneal fluorescein staining using the 0 [none] to 4 [worst] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
Measured: 12 weeks
Conjunctival Lissamine Green Staining Using The Ora Calibra Scale
An assessment of conjunctival lissamine green staining using the 0 [none] to 4 [worst] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
Measured: 12 weeks
Conjunctival Redness Using The Ora Calibra Scale
An assessment of conjunctival redness using the 0 [none] to 4 [worst] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start14 Feb 2020
- Primary completion5 Oct 2020
- Study completion5 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- ORA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Palatin Technologies, Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268069
- Sponsor's protocol ID
- PL9643-201
- Status last verified
- Nov 2020
- First submitted
- 11 Feb 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Evans D, Kenyon K, Ousler G, Watson M, Vollmer P, McLaurin EB, Torkildsen G, Winters J, Dodd J, Jordan R, Wills ST, Spana C. Efficacy and Safety of the Melanocortin Pan-Agonist PL9643 in a Phase 2 Study of Patients with Dry Eye Disease. J Ocul Pharmacol Ther. 2023 Nov;39(9):600-610. doi: 10.1089/jop.2023.0056. Epub 2023 Sep 7.
PubMed 37677000
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-center, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of PL9643 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye
- ClinicalTrials.gov ID
- NCT04268069
- Acronym / sponsor ID
- PL9643-201
- Conditions
- Dry Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- ORA, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Palatin Technologies, Inc
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 5 Oct 2020 (actual)
- First posted
- 13 Feb 2020 (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.
Evaluation of safety and efficacy of PL9643 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye.
Detailed description
The clinical trial is a Phase 2, multi center, randomized, double masked and placebo controlled study.
During a 14-day study run-in period (for the purpose of subject selection) prior to randomization, all subjects will receive Placebo Ophthalmic Solution (vehicle) bilaterally. During the screening period, exposure to the CAE® will be conducted to ascertain eligibility to enter the study at Visit 1 and Visit 2. Those who qualify at Visit 2 will be randomized to receive study drug in a double-masked fashion for 12 weeks. The CAE® exposure will occur at all Visits.
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 |
|---|---|---|
| Placebo Ophthalmic Solution (vehicle) | Placebo comparator | Drug: Placebo Ophthalmic Solutionvehicle |
| PL9643 Ophthalmic Solution | Active comparator | Drug: PL9643 Ophthalmic SolutionPL9643 Ophthalmic Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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 symptoms
- Have corrected visual acuity greater than or equal to +0.7 in both eyes
Key exclusion criteria (9 listed)
- Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal)
- Have any planned ocular and/or lid surgeries over the study period.
- 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
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 |
|---|---|---|
| PL9643 Ophthalmic SolutionPL9643 Ophthalmic Solution as topical ophthalmic drops administered bilaterally for 12 weeks. | Drug | PL9643 Ophthalmic Solution |
| Placebo Ophthalmic SolutionPlacebo solution as topical ophthalmic drops administered bilaterally for 12 weeks. | Drug | Placebo Ophthalmic Solution (vehicle) |
Primary outcome
Inferior Corneal Fluorescein Staining Using The Ora Calibra Scale
Time frame: Day 85
An assessment of corneal fluorescein staining using the 0 [none] to 4 [worst] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
Ocular Discomfort Using The Ora Calibra Scale
Time frame: Day 85
A patient-reported subjective assessment of ocular discomfort using the 0 [none] to 4 [worst] Ora Calibra Scale recorded at each study visit throughout the treatment period
3 secondary outcomes
Corneal Fluorescein Staining Using The Ora Calibra Scale
Time frame: 12 weeks
Conjunctival Lissamine Green Staining Using The Ora Calibra Scale
Time frame: 12 weeks
Conjunctival Redness Using The Ora Calibra Scale
Time frame: 12 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 13 Nov 2020.
- Derived from this study: PubMed 37677000Evans D, Kenyon K, Ousler G, Watson M, Vollmer P, McLaurin EB, Torkildsen G, Winters J, Dodd J, Jordan R, Wills ST, Spana C. Efficacy and Safety of the Melanocortin Pan-Agonist PL9643 in a Phase 2 Study of Patients with Dry Eye Disease. J Ocul Pharmacol Ther. 2023 Nov;39(9):600-610. doi: 10.1089/jop.2023.0056. Epub 2023 Sep 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 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 PL9643 Ophthalmic Solution in people with Dry Eye Disease, run by ORA, Inc. at 4 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 5 inclusion and 9 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 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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?
Inferior Corneal Fluorescein Staining Using The Ora Calibra Scale (time frame: Day 85). 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?
On the ClinicalTrials.gov record for NCT04268069, which also lists 1 linked publication.
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 13 Nov 2020.