Dry Eye Disease Clinical Trial
Official title:
A Phase 2 Multi-Center, Randomized, Double Masked, Placebo Controlled Study to Assess the Safety and Efficacy of ST-100 Ophthalmic Solution in Subjects Diagnosed With Dry Eye Disease
Verified date | February 2024 |
Source | Stuart Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to compare the safety and efficacy of two different concentrations of ST-100 Ophthalmic Solution to placebo (vehicle) for the treatment of the signs and symptoms of dry eye.
Status | Completed |
Enrollment | 160 |
Est. completion date | October 11, 2021 |
Est. primary completion date | October 11, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Be at least 18 years of age; - Provide written informed consent; - Have a subject reported history of dry eye; - Have a history of use of eye drops for dry eye symptoms; - Have symptoms of dry eye as determined by Ocular Discomfort & 4-symptom questionnaire; - Have a Schirmer's Test score of = 10 mm and = 1 mm; - Have conjunctival redness; - Have corneal fluorescein staining; - Have lissamine green conjunctival staining; - Have signs and symptoms responses to Controlled Adverse Environment (CAE®); Exclusion Criteria: - Have any clinically significant slit lamp findings; - Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation ; - Have worn contact lenses; - Have used any eye drops; - Have previously had laser-assisted in situ keratomileusis (LASIK) surgery - Have used Restasis, Xiidra, or Cequa ophthalmic solutions - Have any planned ocular and/or lid surgeries or any ocular surgery; - Have used, are using or anticipate using permanent or temporary punctal plugs during the study; - Be currently taking any topical ophthalmic prescription; - Be currently taking or have taken Omega-3 supplements; - Be unable to read an eye chart; - Be a woman who is pregnant, nursing, or planning a pregnancy; - Be unwilling to submit a urine pregnancy test (or early termination visit) if of childbearing potential; - Be a woman of childbearing potential who is not using an acceptable means of birth control; - Have a known allergy and/or sensitivity to the test article or its components; - Have a condition or be in a situation that the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study; - Be currently enrolled in an investigational drug or device study or have used an investigational drug or device; - Be currently using any medication known to cause ocular drying that is not used on a stable dosing regimen; - Have a known history of meibomian gland procedures (e.g., LipiFlow, LPI, probing, etc.); - Be unable or unwilling to follow instructions, including participation in all study assessments and visits. |
Country | Name | City | State |
---|---|---|---|
United States | Andover Eye Associates | Andover | Massachusetts |
United States | Total Eye Care, P.A. | Memphis | Tennessee |
United States | Andover Eye Associates - Raynham | Raynham | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Stuart Therapeutics, Inc. | ORA, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline of Total Corneal Fluorescein Staining (Ora Calibra® Scale) in the Study Eye at Visit 7 (Day 29) Pre-Controlled Adverse Environment (Pre-CAE) | The fluorescein staining is graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The scale is used to evaluate 3 corneal regions. Staining in each region is graded 0 to 4 where 0 means no staining, and 4 means worst staining. Higher score indicates more staining. The scoring reported ranges from 0-12. Mean change from baseline was calculated. | Visit 2 (Day 1) to Visit 7 (Day 29) | |
Primary | Change From Baseline of Ocular Discomfort in the Study Eye at Visit 7 (Day 29) Pre-CAE | Ocular Discomfort Scale is graded using the Ora Calibra Ocular Discomfort Scale (ODS). The scale ranges from 0 means no discomfort to 4 means worst discomfort. Higher score indicates more discomfort. | Visit 2 (Day 1) to Visit 7 (Day 29) | |
Secondary | Unanesthetized Schirmer's Responder Rate | The Schirmer's test strip is placed in the lower temporal lid margin of each eye. After 5 minutes, the test strip is removed and the length of the moistened area will be recorded in millimeters (mm) for each eye. The percentage of responders who had = 10 mm increase from baseline in study eye in unanesthetized Schirmer's test was recorded. | Visit 7 (Day 29), Pre-CAE | |
Secondary | Change From Baseline of Best-Corrected Visual Acuity (ETDRS) - logMAR (Fellow Eye) at Visit 3 (Day 2) | LogMAR visual acuity (VA) is assessed using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The last line in which a letter is read correctly will be taken as the base logMAR reading. To this value will be added the number "N x 0.02" where 'N' represents the total number of letters missed up to and included in the last line read. This total sum represents the logMAR VA for that eye. | Visit 3 (Day 2) | |
Secondary | Change From Baseline to Visit 4 (Day 4) in Ocular Surface Disease Index (Blurred Vision) | Ocular Surface Disease Index (OSDI) Questions 4: Have you experienced blurred vision during the last week? on 0-4 Scale where 4 is the worst at pre-CAE® | Visit 4 (Day 4), Non-CAE | |
Secondary | Change From Baseline to Visit 6 (Day 15) in Ocular Surface Disease Index (Pain) | Ocular Surface Disease Index (OSDI) Questions 3: Have you experienced painful or sore eyes during the last week? on 0-4 Scale where 4 is the worst at pre-CAE® | Visit 6 (Day 15) Pre-CAE | |
Secondary | Change From Baseline in Ocular Discomfort Assessed by 4-Symptom Questionnaire | The Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire is used, which includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Each symptom rating ranges from 0 to 5, where 0 = None and 5 = Worst. Higher score means worse symptom. Min score = 0, max score = 25. | Visit 6 (Day 15) Pre-CAE |
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