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

ConditionDry Eye Disease (DED)

Trial statusNot yet recruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorPS Therapy Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

A corneal fluorescein staining score of ≥ 2 in at least one corneal region OR have a sum of ≥ 4 in all corneal regions

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

175 Participants

are divided into 4 treatment groups

Group A: 30 subjects assigned to receive RainExperimental treatment 1 intervention

Group B: 30 patients assigned to receive salinePlacebo comparator 1 intervention

Group C: 30 subjects assigned to receive MistExperimental treatment 1 intervention

Group D: 30 patients assigned to receive Systane UltraActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

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

Time frame

4 weeks

Corneal Fluorescein Staining

Mean change from Baseline in Corneal Fluorescein Staining at Visits 1 and 2

Time frame

4 weeks

Conjunctival Staining

Mean change from Baseline in Conjunctival Staining at Visits 1 and 2

Time frame

4 weeks

Secondary outcomes

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.

Time frame

4 weeks

Adverse Events

Adverse Event (AE) Query

Time frame

4 weeks

Slit Lamp Findings

Slit Lamp Biomicroscopy

Time frame

4 weeks

IOP

Intraocular Pressure (IOP)

Time frame

4 weeks

Other outcomes

Tolerability Measures

Drop comfort assessment (0-10 unit scale) assessed by subject immediately upon instillation, at 1 minute, 3 minutes, and 5 minutes post-instillation at Visit 1 and Visit 2.

Time frame

4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PS Therapy Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: