Dry Eye Disease (DED)Early Phase 1NCT06633471
Clinical Study Aimed At Evaluating the Safety and Efficacy of Tear Substitute Formulations in the Treatment of Dry Eye Disease.
A Early Phase 1 study of Dry Eye Disease (DED), run by PS Therapy Inc. at 1 site in Barbados.
Trial summary
This clinical study is aimed at evaluating the safety and effectiveness of 2 test formulations (Rain and Mist), against an approved over-the-counter formulation (Systane Ultra) and a placebo (saline), in the treatment of moderate dry eye disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dry Eye Disease (DED)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 1 siteBarbados
- Study dates
- 4 Nov 2024to 30 Apr 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Each subject must:
- Be at least 18 years of age at the Screening Visit;
- Of either gender and any race;
- Be willing and able to follow all instructions and attend all study visits;
- Have ALL of the following in the study eye1 at the Screening Visit:
- A corneal fluorescein staining score of ≥ 2 in at least one corneal region OR have a sum of ≥ 4 in all corneal regions
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- A baseline Schirmer's Test (with topical anesthesia) Score of ≥ 2 millimeters (mm)/ and ≤ 10 mm/5 minutes
- A physician's diagnosis of Dry Eye Disease
- Have normal lid/lash anatomy, blinking function and closure as determined by the Investigator;
- Be literate and able to complete questionnaires independently;
- Have sufficient hand strength, in the opinion of the Investigator, to be able to independently administer the study drug;
- For females capable of becoming pregnant, agree to have urine pregnancy testing performed at screening (must be negative) and exit visits; must not be lactating; and must agree to use a medically acceptable form of birth control throughout the study. Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months), or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).
Who cannot join
- Each subject must not:
- Have a known hypersensitivity to any of the procedural agents or study drug components, or have previously used the study drug;
- Have clinically significant corneal epithelial defects at Visit 1, prior to performing Schirmer's Test;
- Have had any intraocular surgery (such as cataract surgery) or extraocular surgery in either eye within three months, or refractive surgery (e.g., laser-assisted in-situ keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy or corneal implant) within twelve months of Visit 1;
- Have had blepharoplasty in either eye;
- Have had a corneal transplant in either eye;
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- Have used Restasis® or Xiidra® in the past 60 days;
- Be using any ocular medications, other than the study treatment, within 7 days prior to Visit 1 and throughout the study treatment period. This includes both therapeutic and lubricant eye drops that could potentially interfere with the study outcomes, by either exacerbating or alleviating the symptoms of dry eye disease.
- Have used contact lenses within 7 days prior to Visit 1 or anticipate the use of contact lenses during the study treatment period;
- Have any form of punctal or intracanalicular occlusion;
- Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with DED are allowed;
- Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study, or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.);
- Have active or uncontrolled, severe:
- Systemic allergy
- Chronic seasonal allergies at risk of being active during the study
- Have any condition or history that, in the opinion of the Investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject;
- Be currently enrolled in an investigational drug or device study, or have used an investigational drug or device within 30 days prior to Visit 1 and during the treatment period;
- Be a female who is currently pregnant, planning a pregnancy or lactating.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Barbados1 site
Warrens Eye Care Centre
Bridgetown
Nigel Barker, Dr., 246-230-4146, kerlach@yahoo.com
Nigel Barker, Dr.
About this study
Official title: A Single-Center, Double- Masked, Randomized Study Evaluating the Safety and Efficacy of PS Therapy (PST) Tear Substitute Formulations in the Treatment of the Signs and Symptoms of Moderate Dry Eye Disease.
This clinical study is aimed at evaluating the safety and effectiveness of 2 test formulations (Rain and Mist), against an approved over-the-counter formulation (Systane Ultra) and a placebo (saline), in the treatment of moderate dry eye disease.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- Two test formulations for the treatment of DED are being compared against the approved OTC formulation (Systane Ultra) and saline (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.
Two test formulations for the treatment of DED are being compared against the approved OTC formulation (Systane Ultra) and saline (placebo).Drug
Rain and Mist are the test formulations. Systane Ultra is an approved OTC formulation. Saline is the placebo.
| Study group | Role | What they receive |
|---|---|---|
| 30 subjects assigned to receive Rain | Experimental | Rain is one of the test formulations being evaluated for safety and efficacy in treating DED. Receives: Drug: Two test formulations for the treatment of DED are being compared against the approved OTC formulation (Systane Ultra) and saline (placebo). |
| 30 patients assigned to receive saline | Placebo comparator | Saline is the placebo in this study. Receives: Drug: Two test formulations for the treatment of DED are being compared against the approved OTC formulation (Systane Ultra) and saline (placebo). |
| 30 subjects assigned to receive Mist | Experimental | Mist is one of the test formulations being evaluated for safety and efficacy in treating DED. Receives: Drug: Two test formulations for the treatment of DED are being compared against the approved OTC formulation (Systane Ultra) and saline (placebo). |
| 30 patients assigned to receive Systane Ultra | Active comparator | Systane Ultra is the approved OTC formulation used to treat DED and the comparator for Rain and Mist. Receives: Drug: Two test formulations for the treatment of DED are being compared against the approved OTC formulation (Systane Ultra) and saline (placebo). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schirmer's Test
Mean change in Schirmer's Test Score (STS) from pre-instillation of IP to 5 minutes post-instillation of IP at Visits 1 and 2
Measured: 4 weeks
Tear Film Break Up Time (TFBUT)
Mean change in Tear Film Break Up Time (TFBUT) from baseline to post- instillation of IP at each of Visits 1 and 2
Measured: 4 weeks
Corneal Fluorescein Staining
Mean change from Baseline in Corneal Fluorescein Staining at Visits 1 and 2
Measured: 4 weeks
Conjunctival Staining
Mean change from Baseline in Conjunctival Staining at Visits 1 and 2
Measured: 4 weeks
Ocular Redness
Ocular redness, as evaluated by the Investigator, at Baseline at Visits 1 and 2 (0-4 unit scale, allowing half unit increments) assessed pre-dose at each visit
Measured: 4 weeks
Secondary outcomes (5)
Secondary Efficacy Parameters
Measurement of inflammatory markers using ELISA: Changes in the levels of specific inflammatory markers will be evaluated using Enzyme-Linked Immunosorbent Assay (ELISA) at specified timepoints (Visit 1 and 2) to assess the anti-inflammatory efficacy of the PST Tear formulations.
Measured: 4 weeks
Adverse Events
Adverse Event (AE) Query
Measured: 4 weeks
Slit Lamp Findings
Slit Lamp Biomicroscopy
Measured: 4 weeks
IOP
Intraocular Pressure (IOP)
Measured: 4 weeks
Fundoscopy
Dilated Fundoscopy
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start4 Nov 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PS Therapy Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633471
- Sponsor's protocol ID
- CL001
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 9 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 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Double- Masked, Randomized Study Evaluating the Safety and Efficacy of PS Therapy (PST) Tear Substitute Formulations in the Treatment of the Signs and Symptoms of Moderate Dry Eye Disease.
- ClinicalTrials.gov ID
- NCT06633471
- Acronym / sponsor ID
- CL001
- Conditions
- Dry Eye Disease (DED)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- PS Therapy Inc.University, hospital or other
- Study start
- 4 Nov 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 9 Oct 2024 (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 clinical study is aimed at evaluating the safety and effectiveness of 2 test formulations (Rain and Mist), against an approved over-the-counter formulation (Systane Ultra) and a placebo (saline), in the treatment of moderate dry eye disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 30 subjects assigned to receive Rain | Experimental | Drug: Two test formulations for the treatment of DED are being compared against the approved OTC formulation (Systane Ultra) and saline (placebo).Rain is one of the test formulations being evaluated for safety and efficacy in treating DED. |
| 30 patients assigned to receive saline | Placebo comparator | Drug: Two test formulations for the treatment of DED are being compared against the approved OTC formulation (Systane Ultra) and saline (placebo).Saline is the placebo in this study. |
| 30 subjects assigned to receive Mist | Experimental | Drug: Two test formulations for the treatment of DED are being compared against the approved OTC formulation (Systane Ultra) and saline (placebo).Mist is one of the test formulations being evaluated for safety and efficacy in treating DED. |
| 30 patients assigned to receive Systane Ultra | Active comparator | Drug: Two test formulations for the treatment of DED are being compared against the approved OTC formulation (Systane Ultra) and saline (placebo).Systane Ultra is the approved OTC formulation used to treat DED and the comparator for Rain and Mist. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Be at least 18 years of age at the Screening Visit;
- Of either gender and any race;
- Be willing and able to follow all instructions and attend all study visits;
- Have ALL of the following in the study eye1 at the Screening Visit:
- Have normal lid/lash anatomy, blinking function and closure as determined by the Investigator;
Key exclusion criteria (18 listed)
- Have a known hypersensitivity to any of the procedural agents or study drug components, or have previously used the study drug;
- Have clinically significant corneal epithelial defects at Visit 1, prior to performing Schirmer's Test;
- Have had any intraocular surgery (such as cataract surgery) or extraocular surgery in either eye within three months, or refractive surgery (e.g., laser-assisted in-situ keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy or corneal implant) within twelve months of Visit 1;
- Have had blepharoplasty in either eye;
- Have had a corneal transplant in either eye;
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 |
|---|---|---|
| Two test formulations for the treatment of DED are being compared against the approved OTC formulation (Systane Ultra) and saline (placebo).Rain and Mist are the test formulations. Systane Ultra is an approved OTC formulation. Saline is the placebo. | Drug | 30 patients assigned to receive Systane Ultra, 30 patients assigned to receive saline, 30 subjects assigned to receive Mist, 30 subjects assigned to receive Rain |
Primary outcome
Schirmer's Test
Time frame: 4 weeks
Mean change in Schirmer's Test Score (STS) from pre-instillation of IP to 5 minutes post-instillation of IP at Visits 1 and 2
Tear Film Break Up Time (TFBUT)
Time frame: 4 weeks
Mean change in Tear Film Break Up Time (TFBUT) from baseline to post- instillation of IP at each of Visits 1 and 2
Corneal Fluorescein Staining
Time frame: 4 weeks
Mean change from Baseline in Corneal Fluorescein Staining at Visits 1 and 2
Conjunctival Staining
Time frame: 4 weeks
Mean change from Baseline in Conjunctival Staining at Visits 1 and 2
Ocular Redness
Time frame: 4 weeks
Ocular redness, as evaluated by the Investigator, at Baseline at Visits 1 and 2 (0-4 unit scale, allowing half unit increments) assessed pre-dose at each visit
5 secondary outcomes
Secondary Efficacy Parameters
Time frame: 4 weeks
Adverse Events
Time frame: 4 weeks
Slit Lamp Findings
Time frame: 4 weeks
IOP
Time frame: 4 weeks
Fundoscopy
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study of Dry Eye Disease (DED), run by PS Therapy Inc. at 1 site in Barbados.
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 12 inclusion and 18 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: opening soon, as of the sponsor's last update on 9 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 1 site in Barbados. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nigel Barker, Dr. (246-230-4146, kerlach@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Schirmer's Test (time frame: 4 weeks). The study lists 5 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 9 Oct 2024.