Keratoconjunctivitis Sicca
Conditions
Keywords
Dry Eye
Brief summary
The purpose of this study is to assess the safety and efficacy of Tavilermide Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye disease.
Interventions
1% Tavilermide BID Dosing
DRUGPlacebo Ophthalmic Solution
Vehicle Ophthalmic Solution
Sponsors
Mimetogen Pharmaceuticals USA, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years of age. * Provided written informed consent. * Have a reported history of dry eye Have a history of use or desire to use eye drops for dry eye
Exclusion criteria
* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) at Visit 1. * Be diagnosed with ocular rosacea, or any viral or bacterial disease of the cornea or conjunctiva, within the last 12 months. * Have any planned ocular and/or lid surgeries over the study period. * Have corrected visual acuity greater than or equal to +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit . * Have an uncontrolled systemic disease. * Be a woman who is pregnant, nursing or planning a pregnancy. * 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 which 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 within 45 days of Visit 1 Be unable or unwilling to follow instructions, including participation in all study assessments and visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Corneal Fluorescein Staining Using The Ora Calibra Scale | Day 57 | An assessment of the total corneal fluorescein staining using the Ora Calibra Scale both immediately prior to and immediately following exposure to a challenge in a controlled adverse environment (CAE) |
| Ocular Discomfort Using The Ora Calibra Scale | Day 57 | A patient-reported subjective assessment of ocular discomfort recorded at each of the 5 office visits throughout the treatment period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Corneal Fluorescein Staining Using The Ora Calibra Scale | Day 15 | An assessment of the total corneal fluorescein staining using the Ora Calibra Scale both immediately prior to and immediately following exposure to a challenge in a controlled adverse environment (CAE) |
| Ocular Surface Disease Index | Day 57 | — |
| Ocular Dryness Using The Ora Calibra Scale | 8 weeks | A patient-reported subjective assessment of ocular dryness recorded twice daily over the complete treatment period. |
Countries
United States
Outcome results
None listed