Dry Eye DiseasePhase 2NCT02824913
Study of the Pharmacodynamic Activity of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease
A Phase 2 study testing P-321 Ophthalmic Solution in people with Dry Eye Disease, run by Parion Sciences at 1 site in United States.
Trial summary
The purpose of this Phase 2a study is to assess changes in tear volume by the non-invasive techniques Ultra High Resolution Optical Coherence Tomography (UHR-OCT) following the administration of P-321 Ophthalmic Solution or Placebo in subjects with tear deficient dry eye disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- P-321 Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Mar 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent
- Male or female subjects aged 18 to 80 years
- Have a history of predominantly tear-deficient dry eye of mild to moderate severity, supported by a previous clinical diagnosis
- Have normal lid anatomy
- Subjects must:
- Remain on current medications for the duration of the study and have been on the current medication regimen at least during the past 28 days
Who cannot join
- Have undergone refractive eye surgery in either eye during the past 12 months
- Have undergone uncomplicated cataract surgery in either eye during the past 3 months
- Have undergone previous eyelid surgery in either eye (External blepharoplasty, not resulting in exposure or abnormal blinking is allowed)
- Have undergone botulinum toxin (BotoxTh1 or equivalent) injection in the periocular area within 3 months prior to Visit 1
- Subjects that have a systemic, multi-organ disease requiring active medical or surgical treatment are excluded with the exception of subjects with SS or GVHD
- Have punctal plugs, punctal occlusion, history of nasolacrimal duct obstruction or wear scleral lens.
- Past or present exposure keratopathy, neurotrophic keratopathy, lagophthalmos, or trichiasis
Trial locations and contacts
1 site in 1 country.
United States1 site
Bascom Palmer Eye Institute, University of Miami Health System
Plantation, Florida, 33324
About this study
Official title: Randomized, Crossover Study of the Pharmacodynamic Activity of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease Characterized by Low Tear Volume
The purpose of this Phase 2a study is to assess changes in tear volume by the non-invasive techniques Ultra High Resolution Optical Coherence Tomography (UHR-OCT) following the administration of P-321 Ophthalmic Solution or Placebo in subjects with tear deficient dry eye disease.
Read the detailed description
This is a single-center, randomized, cross-over placebo controlled study to evaluate the changes in tear volume by P-321 Ophthalmic Solution and Placebo. The study will enroll subjects with tear deficient dry eye disease to receive sequentially one of two treatment sequences: P-321 Ophthalmic Solution then Placebo or Placebo then P-321. The study will consist of two Phases: In each Phase, subjects will be treated with P-321 Ophthalmic Solution under the same study design.
Approximately twenty-four eligible subjects will complete the study with approximately 8 subjects participating in Phase 1 and the remainder of the 24 subjects participating in the phase 2. Decisions on the dose to be used in Phase 2 will be made based on Phase 1 data.
The study will consist of three study visits: a Screening Visit (Visit 1), and two treatment visits (Visit 2 and Visit 3). The primary and secondary outcome measures will be assessed at each treatment visit. Safety assessments include adverse events (AEs).
- Conditions
- Dry Eye Disease
- Being tested
- P-321 Ophthalmic Solution, P-321 Ophthalmic Solution placebo
- 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.
P-321 Ophthalmic SolutionDrug
Also called P-321
P-321 Ophthalmic Solution placeboDrug
Also called Placebo Comparator, Placebo
| Study group | Role | What they receive |
|---|---|---|
| P-321 Ophthalmic Solution | Experimental | 0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II Receives: Drug: P-321 Ophthalmic Solution |
| Drug: P-321 Ophthalmic Solution placebo | Placebo comparator | Placebo treatment administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II Receives: Drug: P-321 Ophthalmic Solution placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Tear Meniscus Volume Following the Administration of P-321 Ophthalmic Solution or Placebo
Tear meniscus volume, from measurements of tear meniscus area by UHR-OCT and the length of the eyelid was estimated over time (0 to 6 hours) following administration of placebo or P-321 Ophthalmic Solution.
Measured: Pre-dose and up to six hours after dose
Secondary outcomes (3)
Lower Tear Meniscus Height as Measured by the Keratograph 5M
Tear meniscus height of the inferior eyelid was measured with the Keratograph 5M over time (0 to 6 hours) following the administration of placebo or P-321 Ophthalmic Solution
Measured: Pre-dose and up to six hours after dose
Comparison of Lower Tear Meniscus Height Measurements Between UHR-OCT and Keratograph 5M
Tear meniscus height of the inferior eyelid was measured by UHR-OCT and Keratograph 5M over time (0 to 6 hours) following the administration of placebo or P-321 Ophthalmic Solution
Measured: Pre-dose and up to six hours after dose
Adverse Events
Number of patients experiencing adverse events comparing P-321 to placebo
Measured: 2 or 7 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parion Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Boyer, Study director, Parion Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824913
- Sponsor's protocol ID
- P-321-201
- Status last verified
- Dec 2017
- First submitted
- 1 Jul 2016
- Last updated
- 31 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- 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 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Crossover Study of the Pharmacodynamic Activity of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease Characterized by Low Tear Volume
- ClinicalTrials.gov ID
- NCT02824913
- Acronym / sponsor ID
- P-321-201
- Conditions
- Dry Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Parion SciencesIndustry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Posted 19 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this Phase 2a study is to assess changes in tear volume by the non-invasive techniques Ultra High Resolution Optical Coherence Tomography (UHR-OCT) following the administration of P-321 Ophthalmic Solution or Placebo in subjects with tear deficient dry eye disease.
Detailed description
This is a single-center, randomized, cross-over placebo controlled study to evaluate the changes in tear volume by P-321 Ophthalmic Solution and Placebo. The study will enroll subjects with tear deficient dry eye disease to receive sequentially one of two treatment sequences: P-321 Ophthalmic Solution then Placebo or Placebo then P-321. The study will consist of two Phases: In each Phase, subjects will be treated with P-321 Ophthalmic Solution under the same study design.
Approximately twenty-four eligible subjects will complete the study with approximately 8 subjects participating in Phase 1 and the remainder of the 24 subjects participating in the phase 2. Decisions on the dose to be used in Phase 2 will be made based on Phase 1 data.
The study will consist of three study visits: a Screening Visit (Visit 1), and two treatment visits (Visit 2 and Visit 3). The primary and secondary outcome measures will be assessed at each treatment visit. Safety assessments include adverse events (AEs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P-321 Ophthalmic Solution | Experimental | Drug: P-321 Ophthalmic Solution0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II |
| Drug: P-321 Ophthalmic Solution placebo | Placebo comparator | Drug: P-321 Ophthalmic Solution placeboPlacebo treatment administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provide written informed consent
- Male or female subjects aged 18 to 80 years
- Have a history of predominantly tear-deficient dry eye of mild to moderate severity, supported by a previous clinical diagnosis
- Have normal lid anatomy
- Subjects must:
Key exclusion criteria (7 listed)
- Have undergone refractive eye surgery in either eye during the past 12 months
- Have undergone uncomplicated cataract surgery in either eye during the past 3 months
- Have undergone previous eyelid surgery in either eye (External blepharoplasty, not resulting in exposure or abnormal blinking is allowed)
- Have undergone botulinum toxin (BotoxTh1 or equivalent) injection in the periocular area within 3 months prior to Visit 1
- Subjects that have a systemic, multi-organ disease requiring active medical or surgical treatment are excluded with the exception of subjects with SS or GVHD
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 |
|---|---|---|
| P-321 Ophthalmic SolutionAlso: P-321 | Drug | P-321 Ophthalmic Solution |
| P-321 Ophthalmic Solution placeboAlso: Placebo Comparator, Placebo | Drug | Drug: P-321 Ophthalmic Solution placebo |
Primary outcome
Change in Total Tear Meniscus Volume Following the Administration of P-321 Ophthalmic Solution or Placebo
Time frame: Pre-dose and up to six hours after dose
Tear meniscus volume, from measurements of tear meniscus area by UHR-OCT and the length of the eyelid was estimated over time (0 to 6 hours) following administration of placebo or P-321 Ophthalmic Solution.
3 secondary outcomes
Lower Tear Meniscus Height as Measured by the Keratograph 5M
Time frame: Pre-dose and up to six hours after dose
Comparison of Lower Tear Meniscus Height Measurements Between UHR-OCT and Keratograph 5M
Time frame: Pre-dose and up to six hours after dose
Adverse Events
Time frame: 2 or 7 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jose Boyer study director
Parion Sciences
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 P-321 Ophthalmic Solution in people with Dry Eye Disease, run by Parion Sciences 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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 31 Aug 2018. 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?
Yes. Results are posted in the registry (first posted 19 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Total Tear Meniscus Volume Following the Administration of P-321 Ophthalmic Solution or Placebo (time frame: Pre-dose and up to six hours after dose). 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 31 Aug 2018.