Dry Eye DiseasePhase 2NCT02831387
Evaluation 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 7 sites in United States.
Trial summary
The purpose of this study is to evaluate the effect of treatment with 0.017% P-321 on Dry Eye Symptoms. 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
- 47 participants
- Where
- 7 sitesUnited States
- Study dates
- Jul 2016to Jun 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, inclusive
- Have a history of dry eye disease (DED) in both eyes
- Be on stable regimens of other needed medications
- Have a BCVA of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS)
- Have reported symptoms
- Have the following signs in at least one eye: Schirmer score without anesthesia of >1 and <10 mm at 5 minutes and staining of conjunctival and corneal areas of the eye.
- Have normal lid anatomy
Who cannot join
- Have undergone refractive eye surgery in the past 12 months
- Have undergone previous eyelid surgery in either eye (External blepharoplasty not resulting in exposure or abnormal blinking is allowed)
- Have lid irregularities or deformities
- Have a history of glaucoma, a history of an elevated lOP within the past year, or an lOP in either eye > 25 mmHg at the Screening Visit (Visit 1)
- Have any clinically significant, uncontrolled, or unstable medical or surgical conditions that could affect his or her ability to participate
- Have permanent punctal plugs, punctal occlusion, or history of nasolacrimal duct obstruction. Removable punctal plugs are allowed if they have been used regularly for at least 60 days prior to the screening visit. However, if a plug comes out during the study it must be promptly replaced.
Show all 9Show fewer
- Have clinical findings of severe Meibomian Gland Dysfunction (MGD) in the Study Eye
- Are pregnant or breast feeding
- Use of any investigational product or device within 28 days prior to the Screening Visit or during the study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Sall Research Medical Center
Artesia, California, 90701
UNC Kittner Eye Center
Chapel Hill, North Carolina, 27517
Ocular Surface Center, Baylor College of Medicine
Houston, Texas, 77030
Tauber Eye Center
Kansas City, Missouri, 64111
Virginia Eye Consultants
Norfolk, Virginia, 23502
Ophthalmology Associates
St Louis, Missouri, 63131
Comprehensive Eye Care, Ltd.
Washington, Missouri, 63090
About this study
Official title: Randomized, Double-Masked, Parallel Group Study of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease Assessing Safety and Efficacy Over 28 Days
The purpose of this study is to evaluate the effect of treatment with 0.017% P-321 on Dry Eye Symptoms.
Read the detailed description
This is a multi-center, randomized, double-masked, placebo-controlled, parallel group Phase 2b trial designed to evaluate symptoms and signs in subjects with mild to moderate dry eye disease. Eligible patients, will be treated with placebo during 2-week placebo run-in period. Subjects will then be randomly assigned in a double-masked, 1:1 ratio to either 0.017% P-321 Ophthalmic Solution or placebo TID for 28 days. This study is designed to evaluate the changes in symptoms. Safety will be assessed throughout the study by adverse events.
- 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 0.017%
P-321 Ophthalmic Solution placeboDrug
Also called Placebo
Placebo to match P-321 Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| 0.017% P-321 Ophthalmic Solution | Experimental | 0.017% P-321 Ophthalmic Solution TID for 28 days. Receives: Drug: P-321 Ophthalmic Solution |
| Placebo | Placebo comparator | P-321 Ophthalmic Solution Placebo TID for 28 days. 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 From Baseline (Visit 2) to Day 29 (Visit 4) in the Subject-reported Dry Eye Symptom Questionnaire.
Dry Eye symptoms were obtained using the Symptom Assessment in Dry Eye (SANDE) questionnaire. The questionnaire utilizes separate Visual Analog Scales (VAS) for the frequency and the Severity of symptoms. The scores range from 0 to 100 where 0 = Rarely or Very Mild, and 100 = All the Time or Very Severe for the Frequency and Severity of the symptoms, respectively. The Global Score as reported in the Primary Outcome is obtained by taking the square root of the product of the frequency score multiplied by the severity score. Negative change from baseline indicates improvement.
Measured: Baseline to Day 29
Secondary outcomes (6)
Change From Baseline (Visit 2) to Day 29 in Symptom Frequency Scores
Dry Eye symptom frequency was obtained using the Symptom Assessment in Dry Eye (SANDE) questionnaire. The questionnaire utilizes a 100 mm horizontal Visual Analog Scale (VAS). The scores range from 0 to 100 where 0 = Rarely and 100 = All the Time. A negative change from baseline indicates improvement.
Measured: Baseline to Day 29
Change From Baseline (Visit 2) to Day 29 in Symptom Severity Scores
Dry Eye symptom severity was obtained using the Symptom Assessment in Dry Eye (SANDE) questionnaire. The questionnaire utilizes a 100 mm horizontal Visual Analog Scales (VAS). The scores range from 0 to 100 where 0 = Very Mild and 100 = Very Severe. A negative change from baseline indicates improvement.
Measured: Baseline to Day 29
Change From Baseline to Day 29 in Fluorescein Staining of the Cornea.
Corneal staining was performed to grade the corneal epithelial cell injury as measured by fluorescence using slit lamp examination. The staining was graded with the NEI scale. The corneal surface is divided into 5 corneal regions (1, Central; 2, Inferior; 3, Nasal; 4, Temporal; 5, Superior). The scores for each of these 5 regions ranged from 0 to 3 (0=no staining; 1=staining with low density; 2=staining with moderate density; 3=staining with severe density). The total staining score (sum of all regions, maximal score =15) is reported. A negative change from baseline indicates improvement.
Measured: Baseline to Day 29
Change From Baseline to Day 29 in Lissamine Green Staining of the Conjunctiva.
Conjunctival staining was performed to grade the conjunctival epithelial cell injury as measured by Lissamine Green using slit-lamp examination. The staining was graded with the NEI scale. The bulbar conjunctival surface is divided into 6 regions (1, Temporal; 2 Temporal Superior; 3, Temporal Inferior; 4, Nasal Superior; 5, Nasal Inferior; 6, Nasal). The scores for each of these 6 regions ranged from 0 to 3 (0=no staining; 1=staining with low density; 2=staining with moderate density; 3=staining with severe density). The total staining score (sum of all regions, maximal score =18) is reported. A negative change from baseline indicates improvement.
Measured: Baseline to Day 29
Number of Participants With at Least 20% Improvement in Symptoms From Baseline to Day 29
Improvement in symptoms was evaluated using the Symptom Assessment in Dry Eye (SANDE) questionnaire. The questionnaire utilizes separate Visual Analog Scales (VAS) for the frequency and the Severity of symptoms. The scores range from 0 to 100 where 0 = Rarely or Very Mild, and 100 = All the Time or Very Severe for the Frequency and Severity of the symptoms, respectively. The Global Score is obtained by taking the square root of the product of the frequency score multiplied by the severity score. Lower scores indicate improvement in symptoms.
Measured: Baseline to Day 29
Change From Baseline (Visit 2) to Day 15 (Visit 3) in the Subject-reported Dry Eye Symptom Score.
Dry Eye symptoms were obtained using the Symptom Assessment in Dry Eye (SANDE) questionnaire. The questionnaire utilizes separate Visual Analog Scales (VAS) for the frequency and the Severity of symptoms. The scores range from 0 to 100 where 0 = Rarely or Very Mild, and 100 = All the Time or Very Severe for the Frequency and Severity of the symptoms, respectively. The Global Score as reported in the Primary Outcome is obtained by taking the square root of the product of the frequency score multiplied by the severity score. A negative change from baseline indicates improvement.
Measured: Baseline to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2017
- Study completionJun 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 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
- NCT02831387
- Sponsor's protocol ID
- P-321-202
- Status last verified
- Aug 2017
- First submitted
- 1 Jul 2016
- Last updated
- 11 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Masked, Parallel Group Study of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease Assessing Safety and Efficacy Over 28 Days
- ClinicalTrials.gov ID
- NCT02831387
- Acronym / sponsor ID
- P-321-202
- Conditions
- Dry Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Parion SciencesIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 13 Jul 2016 (estimated)
- Results
- Posted 11 Oct 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 study is to evaluate the effect of treatment with 0.017% P-321 on Dry Eye Symptoms.
Detailed description
This is a multi-center, randomized, double-masked, placebo-controlled, parallel group Phase 2b trial designed to evaluate symptoms and signs in subjects with mild to moderate dry eye disease. Eligible patients, will be treated with placebo during 2-week placebo run-in period. Subjects will then be randomly assigned in a double-masked, 1:1 ratio to either 0.017% P-321 Ophthalmic Solution or placebo TID for 28 days. This study is designed to evaluate the changes in symptoms. Safety will be assessed throughout the study by adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.017% P-321 Ophthalmic Solution | Experimental | Drug: P-321 Ophthalmic Solution0.017% P-321 Ophthalmic Solution TID for 28 days. |
| Placebo | Placebo comparator | Drug: P-321 Ophthalmic Solution placeboP-321 Ophthalmic Solution Placebo TID for 28 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provide written informed consent
- Male or female subjects aged 18 to 80 years, inclusive
- Have a history of dry eye disease (DED) in both eyes
- Be on stable regimens of other needed medications
- Have a BCVA of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS)
Key exclusion criteria (9 listed)
- Have undergone refractive eye surgery in the past 12 months
- Have undergone previous eyelid surgery in either eye (External blepharoplasty not resulting in exposure or abnormal blinking is allowed)
- Have lid irregularities or deformities
- Have a history of glaucoma, a history of an elevated lOP within the past year, or an lOP in either eye > 25 mmHg at the Screening Visit (Visit 1)
- Have any clinically significant, uncontrolled, or unstable medical or surgical conditions that could affect his or her ability to participate
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-321P-321 Ophthalmic Solution 0.017% | Drug | 0.017% P-321 Ophthalmic Solution |
| P-321 Ophthalmic Solution placeboAlso: PlaceboPlacebo to match P-321 Ophthalmic Solution | Drug | Placebo |
Primary outcome
Change From Baseline (Visit 2) to Day 29 (Visit 4) in the Subject-reported Dry Eye Symptom Questionnaire.
Time frame: Baseline to Day 29
Dry Eye symptoms were obtained using the Symptom Assessment in Dry Eye (SANDE) questionnaire. The questionnaire utilizes separate Visual Analog Scales (VAS) for the frequency and the Severity of symptoms. The scores range from 0 to 100 where 0 = Rarely or Very Mild, and 100 = All the Time or Very Severe for the Frequency and Severity of the symptoms, respectively. The Global Score as reported in the Primary Outcome is obtained by taking the square root of the product of the frequency score multiplied by the severity score. Negative change from baseline indicates improvement.
6 secondary outcomes
Change From Baseline (Visit 2) to Day 29 in Symptom Frequency Scores
Time frame: Baseline to Day 29
Change From Baseline (Visit 2) to Day 29 in Symptom Severity Scores
Time frame: Baseline to Day 29
Change From Baseline to Day 29 in Fluorescein Staining of the Cornea.
Time frame: Baseline to Day 29
Change From Baseline to Day 29 in Lissamine Green Staining of the Conjunctiva.
Time frame: Baseline to Day 29
Number of Participants With at Least 20% Improvement in Symptoms From Baseline to Day 29
Time frame: Baseline to Day 29
Change From Baseline (Visit 2) to Day 15 (Visit 3) in the Subject-reported Dry Eye Symptom Score.
Time frame: Baseline to Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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
7 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 P-321 Ophthalmic Solution in people with Dry Eye Disease, run by Parion Sciences at 7 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 8 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: stopped early, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Yes. Results are posted in the registry (first posted 11 Oct 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 From Baseline (Visit 2) to Day 29 (Visit 4) in the Subject-reported Dry Eye Symptom Questionnaire. (time frame: Baseline to Day 29). 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 11 Oct 2018.