Clinical Study Aimed At Evaluating the Safety and Efficacy of Tear Substitute Formulations in the Treatment of Dry Eye Disease.

Early Phase 1

Not yet recruiting

• Conditions: Dry Eye Disease (DED)
• Interventions: Drug: Two test formulations for the treatment of DED are being compared against the approved OTC formulation (Systane Ultra) and saline (placebo).

• Registration Number: NCT06633471
• Lead Sponsor: PS Therapy Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-01
• Study First Submitted QC: 2024-10-08
• Last Update Submitted: 2024-10-08
• Study First Posted: 2024-10-09
• Last Update Posted: 2024-10-09
• Study Start: 2024-11-04
• Primary Completion: 2025-02-28
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

Each subject must:

1. Be at least 18 years of age at the Screening Visit;

2. Of either gender and any race;

3. Be willing and able to follow all instructions and attend all study visits;

4. Have ALL of the following in the study eye1 at the Screening Visit:

   1. A corneal fluorescein staining score of ≥ 2 in at least one corneal region OR have a sum of ≥ 4 in all corneal regions
   2. A baseline Schirmer's Test (with topical anesthesia) Score of ≥ 2 millimeters (mm)/ and ≤ 10 mm/5 minutes
   3. A physician's diagnosis of Dry Eye Disease

5. Have normal lid/lash anatomy, blinking function and closure as determined by the Investigator;

6. Be literate and able to complete questionnaires independently;

7. Have sufficient hand strength, in the opinion of the Investigator, to be able to independently administer the study drug;

8. 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).

Exclusion Criteria

Each subject must not:

1. Have a known hypersensitivity to any of the procedural agents or study drug components, or have previously used the study drug;

2. Have clinically significant corneal epithelial defects at Visit 1, prior to performing Schirmer's Test;

3. 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;

4. Have had blepharoplasty in either eye;

5. Have had a corneal transplant in either eye;

6. Have used Restasis® or Xiidra® in the past 60 days;

7. 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.

8. Have used contact lenses within 7 days prior to Visit 1 or anticipate the use of contact lenses during the study treatment period;

9. Have any form of punctal or intracanalicular occlusion;

10. 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;

11. 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.);

12. Have active or uncontrolled, severe:

    • Systemic allergy
    • Chronic seasonal allergies at risk of being active during the study

13. 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;

14. 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;

15. Be a female who is currently pregnant, planning a pregnancy or lactating.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30 subjects assigned to receive Rain	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	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	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	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.

Primary Outcome Measures

Name	Time	Method
Schirmer's Test	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)	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	4 weeks	Mean change from Baseline in Corneal Fluorescein Staining at Visits 1 and 2
Conjunctival Staining	4 weeks	Mean change from Baseline in Conjunctival Staining at Visits 1 and 2
Ocular Redness	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

Secondary Outcome Measures

Name	Time	Method
Secondary Efficacy Parameters	4 weeks	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.
Adverse Events	4 weeks	Adverse Event (AE) Query
Slit Lamp Findings	4 weeks	Slit Lamp Biomicroscopy
IOP	4 weeks	Intraocular Pressure (IOP)
Fundoscopy	4 weeks	Dilated Fundoscopy

Trial Locations

Locations (1)

Warrens Eye Care Centre; 🇧🇧 Bridgetown, Barbados