Dry Eye Syndromes
Conditions
Brief summary
The purpose of this study is to assess the safety and efficacy of MIM-D3 Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye.
Interventions
1% MIM-D3 dosed BID
DRUGVehicle
Vehicle dosed BID
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), or active ocular inflammation (e.g. follicular conjunctivitis) at Visit 1, or have been 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 1 * 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; acceptable methods of contraception include: hormonal - oral, implantable, injectable, or transdermal contraceptives; mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom; IUD; or surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use adequate birth control as defined above for the remainder of the study * 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 |
|---|---|---|
| Corneal Fluorescein Staining | Day 29 | — |
| Ocular Dryness | 28 Days | Patient-derived, daily dryness symptoms for the 28 day time period will be be averaged to obtain a dryness score for the entire 28-day period. Average dryness scores over the 28-day treatment period will be compared between 1% MIM-D3 and placebo using t-tests. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Ocular Fluorescein Staining | Day 29 | — |
| Ocular Discomfort | 28 Days | Patient-derived daily diary ocular discomfort symptoms for the 28 day time period will be averaged to obtain an ocular discomfort score for the entire 28-day period. Average ocular discomfort scores over the 28-day treatment period will be compared between 1% MIM-D3 and placebo using t-tests. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fluorescein staining (Ora CalibraTM Scale) | Day 15, 29 and 57 | Fluorescein Staining, (pre and post-CAESM; by individual region: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total), by both grade and clearance of staining; |
| Lissamine green staining (Ora CalibraTM Scale,) | Day 15, 29 and 57 | Lissamine green staining (pre and post-CAESM; regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total) |
| Subject diary individual symptoms | 28-day and 56-day treatment periods | — |
| Tear film break-up time | Day 15, 29 and 57 | Tear film break-up time (pre and post-CAESM); |
Countries
United States
Outcome results
None listed