Dry Eye DiseasePhase 1NCT02242032
Study of the Safety and Tolerability of P 321 Ophthalmic Solution in Subjects With Dry Eye Disease
A Phase 1 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 study is to assess the safety and tolerability of P-321 Ophthalmic Solution in subjects with mild to moderate 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
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Mar 2015
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals of both genders and any race will be eligible for study participation if they:
- Provide written informed consent.
- Are 18 - 80 years of age.
- Corneal fluorescein staining score ≥2/15 on the NEI/Industry scale
- Conjunctival lissamine staining score of ≥ 2/18 on the NEI/Industry scale
- Schirmer <10mm/5min
Show all 11Show fewer
- Are willing and able to follow instructions and can be present for the required study visits for the duration of the study.
- Female patients of child bearing potential must have a negative urine pregnancy test at Screening and agree to use a medically acceptable form of birth control. Male subjects who are sexually active must be willing to use highly effective contraception (i.e., less than 1% failure rate) during heterosexual intercourse from Day 1 through completion of the study.
- Have a history of Dry Eye Disease in both eyes supported by a previous clinical diagnosis or have a self-reported history of subjective complaints for at least 4 months prior to Screening, low tear volume, and ocular staining.
- Have documented history of topical lubricants at least daily or the desire to use topical lubricants in the past 4 months.
- Have normal lid anatomy
Who cannot join
- Individuals are not eligible for study participation if:
- Have anterior segment eye disease except primary dry eye.
- Patients with an identifiable or suspected secondary dry eye, i.e., a documented or likely systemic, ocular, pharmacologic, post-traumatic, post-surgical, or external cause for dry eye symptoms or ocular surface staining.
- Patients with current punctal plugs, punctal occlusion, or history of nasolacrimal duct obstruction are excluded.
- Have a history of glaucoma or intraocular pressure (IOP) > 25 mmHg at the Screening Visit (Visit 1) or a history of elevated IOP within the past year prior to Visit 1
- Contact lenses wear in the previous 30 days or during the Treatment Phase of the study.
Show all 11Show fewer
- Use of lid scrubs (including baby shampoos)
- Known hypersensitivity to the study investigational medicinal product, or formulation excipients, including amiloride or related drugs or allergies to the components of the study drug.
- Any significant chronic illness that, in the opinion of the Principal Investigator (PI), could interfere with the study parameters.
- Use of any investigational product or device within 30 days prior to the Screening Visit or during the study.
- Those unable in the opinion of the PI to comply fully with the study requirements or complete the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sall Research Medical Center
Artesia, California, 90701
About this study
Official title: A Double-Masked, Randomized, Placebo-Controlled Dose Escalation Study of the Safety and Tolerability of P 321 Ophthalmic Solution in Subjects With Dry Eye Disease
The purpose of this study is to assess the safety and tolerability of P-321 Ophthalmic Solution in subjects with mild to moderate dry eye disease.
Read the detailed description
This is a single-center, dose escalation, randomized, double-masked, placebo-controlled, Phase 1/2a trial designed to evaluate the safety and tolerability of P-321 Ophthalmic Solution in subjects with mild to moderate dry eye for up to 4-weeks of treatment and up to 8 scheduled in clinic visits. This study will conduct a consecutive dose escalation of the following concentrations of P-321 Ophthalmic Solution given two times a day via ocular instillation: 0.0005% (Cohort 1), 0.0015% (Cohort 2), 0.005% (Cohort 3), and 0.01% (Cohort 4). Up to 48 subjects will be enrolled in four consecutive cohorts. Subjects will be randomized to P-321 Ophthalmic Solution or placebo in a 3:1 ratio.
Safety and tolerability assessments, drug plasma concentrations and drug urine concentrations will be evaluated throughout the study in all cohorts.
- Conditions
- Dry Eye Disease
- Being tested
- P-321 Ophthalmic Solution, P-321 Ophthalmic Solution placebo
- Keywords
- dry eye disease
- 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
Placebo to match P-321 Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| P-321 | Experimental | P-321 Ophthalmic Solution Receives: Drug: P-321 Ophthalmic Solution |
| P-321 Ophthalmic Solution Placebo | Placebo comparator | P-321 Ophthalmic Solution Placebo Receives: Drug: P-321 Ophthalmic Solution placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
One primary objective of this trial is to assess the safety of P-321 Ophthalmic Solution versus placebo in subjects with moderate dry eye disease at 14 days (Cohorts 1-4) and 28 days (Cohort 4 only).
Measured: Days 0, 1, 2, 8, 15, 22 and 28
Changes from baseline in 14 days in visual acuity.
Change from baseline at 14 days in visual acuity.
Measured: Change from baseline at 14 days.
Change from baseline at 28 days in visual acuity for Cohort 4 only.
Change from baseline at 28 days in visual acuity for Cohort 4 only.
Measured: Change from baseline at 28 days in visual acuity.
Changes from baseline at 14 days in corneal staining.
Changes from baseline at 14 days in corneal staining.
Measured: Changes from baseline at 14 days.
Changes from baseline at 28 days in corneal staining for cohort 4 only.
Changes from baseline at 28 days in corneal staining for cohort 4 only.
Measured: Changes from baseline at 28 days.
Changes from baseline at 14 days in conjunctival staining.
Changes from baseline at 14 days in conjunctival staining.
Measured: Changes from baseline at 14 days
Changes from baseline at 28 days in conjunctival staining for Cohort 4 only.
Changes from baseline at 28 days in conjunctival staining for Cohort 4 only.
Measured: Changes from baseline at 28 days
Changes from baseline at 14 days in intraocular pressure.
Changes from baseline at 14 days in intraocular pressure.
Measured: Changes from baseline at 14 days.
Changes from baseline at 28 days in intraocular pressure. for Cohort 4 only.
Changes from baseline at 28 days in intraocular pressure. for Cohort 4 only.
Measured: Changes from baseline at 28 days
Changes from baseline at 14 days in ophthalmoscopy.
Changes from baseline at 14 days in ophthalmoscopy.
Measured: Changes from baseline at 14 days
Changes from baseline at 28 days in ophthalmoscopy for Cohort 4 only.
Changes from baseline at 28 days in ophthalmoscopy for Cohort 4 only.
Measured: Changes from baseline at 28 days
Secondary outcomes (6)
Measure plasma P-321 concentrations
Drug plasma concentrations will be evaluated pre-dose 0.5, 1, 2, 4, and 6 hours post dosing on Days 1 and 15 and pre-dose on Day 8.
Measured: Pre-dose 0.5, 1, 2, 4, and 6 hours post dosing on Days 1 and Day 15 and pre-dose on Day 8.
Measure urine concentrations of P-321
Drug urine concentrations will be evaluated at Day 1 and Day 15.
Measured: At multiple timepoints throughout the study
Measure tear concentrations of P-321
Drug tear concentrations will be evaluated at all visits post dose.
Measured: pre-dose 0.5, 1, 2, 4, and 6 hours post dosing on Day 1 and Day 15 and pre-dose on Day 8.
Measure plasma P-321 concentrations in Cohort 4
Measure plasma P-321 concentrations in Cohort 4
Measured: pre-dose on Day 8 and Day 22, and pre-dose, 0.5, 1, 2, 4, 6, 8, and 24 hours post-dose on Day 28
Measure urine concentrations of P-321 in Cohort 4
Measure urine concentrations of P-321 in Cohort 4
Measured: Day 28
Measure tear concentrations of P-321 in Cohort 4
Measure tear concentrations of P-321 in Cohort 4
Measured: pre-dose on Day 8 and Day 22, and pre-dose, 0.5, 1, 2, 4, 6, 8, and 24 hours post-dose on Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parion Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth Sall, MD, Principal investigator, Sall Research Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242032
- Sponsor's protocol ID
- P-321-101
- Status last verified
- May 2015
- First submitted
- 28 Aug 2014
- Last updated
- 4 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Masked, Randomized, Placebo-Controlled Dose Escalation Study of the Safety and Tolerability of P 321 Ophthalmic Solution in Subjects With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT02242032
- Acronym / sponsor ID
- P-321-101
- Conditions
- Dry Eye Disease
- Keywords
- dry eye disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Parion SciencesIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 16 Sep 2014 (estimated)
- 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.
The purpose of this study is to assess the safety and tolerability of P-321 Ophthalmic Solution in subjects with mild to moderate dry eye disease.
Detailed description
This is a single-center, dose escalation, randomized, double-masked, placebo-controlled, Phase 1/2a trial designed to evaluate the safety and tolerability of P-321 Ophthalmic Solution in subjects with mild to moderate dry eye for up to 4-weeks of treatment and up to 8 scheduled in clinic visits. This study will conduct a consecutive dose escalation of the following concentrations of P-321 Ophthalmic Solution given two times a day via ocular instillation: 0.0005% (Cohort 1), 0.0015% (Cohort 2), 0.005% (Cohort 3), and 0.01% (Cohort 4). Up to 48 subjects will be enrolled in four consecutive cohorts. Subjects will be randomized to P-321 Ophthalmic Solution or placebo in a 3:1 ratio.
Safety and tolerability assessments, drug plasma concentrations and drug urine concentrations will be evaluated throughout the study in all cohorts.
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 |
|---|---|---|
| P-321 | Experimental | Drug: P-321 Ophthalmic SolutionP-321 Ophthalmic Solution |
| P-321 Ophthalmic Solution Placebo | Placebo comparator | Drug: P-321 Ophthalmic Solution placeboP-321 Ophthalmic Solution Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Individuals of both genders and any race will be eligible for study participation if they:
Key exclusion criteria (11 listed)
- Individuals are not eligible for study participation if:
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 |
| P-321 Ophthalmic Solution placeboAlso: placeboPlacebo to match P-321 Ophthalmic Solution | Drug | P-321 Ophthalmic Solution Placebo |
Primary outcome
Number of subjects with adverse events
Time frame: Days 0, 1, 2, 8, 15, 22 and 28
One primary objective of this trial is to assess the safety of P-321 Ophthalmic Solution versus placebo in subjects with moderate dry eye disease at 14 days (Cohorts 1-4) and 28 days (Cohort 4 only).
Changes from baseline in 14 days in visual acuity.
Time frame: Change from baseline at 14 days.
Change from baseline at 14 days in visual acuity.
Change from baseline at 28 days in visual acuity for Cohort 4 only.
Time frame: Change from baseline at 28 days in visual acuity.
Change from baseline at 28 days in visual acuity for Cohort 4 only.
Changes from baseline at 14 days in corneal staining.
Time frame: Changes from baseline at 14 days.
Changes from baseline at 14 days in corneal staining.
Changes from baseline at 28 days in corneal staining for cohort 4 only.
Time frame: Changes from baseline at 28 days.
Changes from baseline at 28 days in corneal staining for cohort 4 only.
Changes from baseline at 14 days in conjunctival staining.
Time frame: Changes from baseline at 14 days
Changes from baseline at 14 days in conjunctival staining.
Changes from baseline at 28 days in conjunctival staining for Cohort 4 only.
Time frame: Changes from baseline at 28 days
Changes from baseline at 28 days in conjunctival staining for Cohort 4 only.
Changes from baseline at 14 days in intraocular pressure.
Time frame: Changes from baseline at 14 days.
Changes from baseline at 14 days in intraocular pressure.
Changes from baseline at 28 days in intraocular pressure. for Cohort 4 only.
Time frame: Changes from baseline at 28 days
Changes from baseline at 28 days in intraocular pressure. for Cohort 4 only.
Changes from baseline at 14 days in ophthalmoscopy.
Time frame: Changes from baseline at 14 days
Changes from baseline at 14 days in ophthalmoscopy.
Changes from baseline at 28 days in ophthalmoscopy for Cohort 4 only.
Time frame: Changes from baseline at 28 days
Changes from baseline at 28 days in ophthalmoscopy for Cohort 4 only.
6 secondary outcomes
Measure plasma P-321 concentrations
Time frame: Pre-dose 0.5, 1, 2, 4, and 6 hours post dosing on Days 1 and Day 15 and pre-dose on Day 8.
Measure urine concentrations of P-321
Time frame: At multiple timepoints throughout the study
Measure tear concentrations of P-321
Time frame: pre-dose 0.5, 1, 2, 4, and 6 hours post dosing on Day 1 and Day 15 and pre-dose on Day 8.
Measure plasma P-321 concentrations in Cohort 4
Time frame: pre-dose on Day 8 and Day 22, and pre-dose, 0.5, 1, 2, 4, 6, 8, and 24 hours post-dose on Day 28
Measure urine concentrations of P-321 in Cohort 4
Time frame: Day 28
Measure tear concentrations of P-321 in Cohort 4
Time frame: pre-dose on Day 8 and Day 22, and pre-dose, 0.5, 1, 2, 4, 6, 8, and 24 hours post-dose on Day 28
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 4 May 2015.
Related trials for Dry Eye Disease
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
Recruiting
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
Dry Eye Disease
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
Dry Eye Disease (DED), Contact Lens Discomfort (CLD)
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.
Kenneth Sall, MD principal investigator
Sall Research Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 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 11 inclusion and 11 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 4 May 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of subjects with adverse events (time frame: Days 0, 1, 2, 8, 15, 22 and 28). The study lists 11 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 4 May 2015; AzTrials last refreshed its copy on 8 Nov 2026.