Raw Ground Truth
Inclusion Criteria:Provide written informed consentMale or female subjects aged 18 to 80 years, inclusiveHave a history of dry eye disease (DED) in both eyesBe on stable regimens of other needed medicationsHave a BCVA of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS)Have reported symptomsHave the following sings in at least one eye: Schirmer score without anesthesia of >1 and <10 mm at 5 minutes and staining of conjunctival and corneal areas of the eye.Have normal lid anatomyExclusion Criteria:Have undergone refractive eye surgery in the past 12 monthsHave undergone previous eyelid surgery in either eye (External blepharoplasty not resulting in exposure or abnormal blinking is allowed)Have lid irregularities or deformitiesHave a history of glaucoma, a history of an elevated lOP within the past year, or an lOP in either eye > 25 mmHg at the Screening Visit (Visit 1)Have any clinically significant, uncontrolled, or unstable medical or surgical conditions that could affect his or her ability to participateHave permanent punctal plugs, punctal occlusion, or history of nasolacrimal duct obstruction. Removable punctal plugs are allowed if they have been used regularly for at least 60 days prior to the screening visit. However, if a plug comes out during the study it must be promptly replaced.Have clinical findings of severe Meibomian Gland Dysfunction (MGD) in the Study EyeAre pregnant or breast feedingUse of any investigational product or device within 28 days prior to the Screening Visit or during the study
Raw Prediction
Amended Eligibility Criteria (version 3):
Inclusion Criteria:
- Provide written informed consent
- Male or female subjects aged 18 to 80 years, inclusive
- Have a history of dry eye disease (DED) in both eyes
- Be on stable regimens of other needed medications
- Have a BCVA of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS)
- Report symptoms
- Have a Schirmer score without anesthesia of >1 and <10 mm at 5 minutes in both eyes and have staining of conjunctival and corneal areas of the eye
- Have normal lid anatomy
- Have a serum potassium level at Screening Visit (Visit 1) of 1.1 times the normal upper limit
- Have any clinically significant, uncontrolled, or unstable medical or surgical conditions that could affect his or her ability to participate in the study or potentially compromise his or her well-being during the study
- Have not taken any of the excluded medications within 14 days of Screening or during the study
- Are not pregnant or breast feeding
- Use of any investigational product or device within 28 days prior to the Screening Visit or during the study
Exclusion Criteria:
- Have undergone refractive eye surgery
- Have undergone previous eyelid surgery in either eye
- Have lid irregularities or deformities
- Have a history of glaucoma, a history of an elevated IOP within the past year, or an IOP in either eye > 25 mmHg at the Screening Visit (Visit 1)
- Have any clinically significant, uncontrolled, or unstable medical or surgical conditions that could affect his or her ability to participate in the study
- Have permanent punctal plugs, punctal occlusion, or history of nasolacrimal duct obstruction. Removable punctal plugs are allowed if they have been used regularly for at least 60 days prior to the screening visit. However, if a plug comes out during the study it must be promptly replaced.
- Have clinical findings of severe Meibomian Gland Dysfunction (MGD) in the Study Eye
- Have required treatment with LipiFlow®, MeiboFlow®, or Blephex™ use within the past 3 months
- Have a history of Stevens-Johnson syndrome, ocular cicatricial pemphigoid (OCP), or other ocular cicatrizing disorders
- Have a history of exposure keratopathy, neurotrophic keratopathy, lagophthalmos, or trichiasis
- Have used contact lenses within 28 days of Visit 1 or anticipate needing to use contacts during the study
- Have used lid scrubs (including baby shampoos) in the past 28 days
- Have a known hypersensitivity or allergy to the study investigational medicinal product, or formulation excipients, including amiloride or related drugs
- Have taken within 14 days of Screening or will need to take any of the following medications during the study:
- Any topical prescription or over-the-counter (OTC) ocular medication including topical cyclosporine (e.g. Restasis®), lifitegrast (Xiidra®), or topical anti-glaucoma medications
- Ocular, intranasal or systemic corticosteroids or other immunomodulatory or immunosuppressive medications
- Topical ocular or systemic antibiotics, including doxycycline or tetracycline analogs
- Oral or topical secretagogues such as pilocarpine and cevimeline (Evoxac®)
- Systemic medications with known significant anticholinergic pharmacologic activity as referenced in the Prohibited Medication List for the study, such as tricyclic antidepressants. Selective Serotonin Re-uptake Inhibitors (SSRIs) are permitted if patient is on stable dose for 28 days prior to Visit 1 and during the study
- The following medications are explicitly excluded for 14 days prior to Randomization Visit and throughout the study:
- Nasal, ocular, or oral antihistamines
- NSAIDs (non-steroidal anti-inflammatory drugs) or aspirin use with the exception of low dose (81mg) aspirin per day
- Topical autologous serum
- Lubricant eye drops
- Are an employee of the site that is directly involved in the management, administration, or support of this study or be an immediate family member of the same
- Are unable in the opinion of the PI to comply fully with the study requirements or to complete the study
- Have taken within 14 days of Screening or will need to take any of the following medications during the study:
- Any topical prescription or OTC ocular medication including topical cyclosporine (e.g. Restasis®), lifitegrast (Xiidra®), or topical anti-glaucoma medications
- Ocular, intranasal or systemic corticosteroids or other immunomodulatory or immunosuppressive medications
- Topical ocular or systemic antibiotics, including doxycycline or tetracycline analogs
- Oral or topical secretagogues such as pilocarpine and cevimeline (Evoxac®)
- Systemic medications with known significant anticholinergic pharmacologic activity as referenced in the Prohibited Medication List for the study, such as tricyclic antidepressants. Selective Serotonin Re-uptake Inhibitors (SSRIs) are permitted if patient is on stable dose for 28 days prior to Visit 1 and during the study
- Have taken within 14 days of Screening or will need to take any of the following medications during the study:
- Any topical prescription or OTC ocular medication including topical cyclosporine (e.g. Restasis®), lifitegrast (Xiidra®), or topical anti-glaucoma medications
- Ocular, intranasal or systemic corticosteroids or other immunomodulatory or immunosuppressive medications
- Topical ocular or systemic antibiotics, including doxycycline or tetracycline analogs
- Oral or topical secretagogues such as pilocarpine and cevimeline (Evoxac®)
- Systemic medications with known significant anticholinergic pharmacologic activity as referenced in the Prohibited Medication List for the study, such as tricyclic antidepressants. Selective Serotonin Re-uptake Inhibitors (SSRIs) are permitted if patient is on stable dose for 28 days prior to Visit 1 and during the study
Processed Ground Truth
1. Provide written informed consentMale or female subjects aged 18 to 80 years, inclusiveHave a history of dry eye disease (DED) in both eyesBe on stable regimens of other needed medicationsHave a BCVA of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS)Have reported symptomsHave the following sings in at least one eye: Schirmer score without anesthesia of >1 and <10 mm at 5 minutes and staining of conjunctival and corneal areas of the eye.Have normal lid anatomyExclusion Criteria:Have undergone refractive eye surgery in the past 12 monthsHave undergone previous eyelid surgery in either eye (External blepharoplasty not resulting in exposure or abnormal blinking is allowed)Have lid irregularities or deformitiesHave a history of glaucoma, a history of an elevated lOP within the past year, or an lOP in either eye > 25 mmHg at the Screening Visit (Visit 1)Have any clinically significant, uncontrolled, or unstable medical or surgical conditions that could affect his or her ability to participateHave permanent punctal plugs, punctal occlusion, or history of nasolacrimal duct obstruction. Removable punctal plugs are allowed if they have been used regularly for at least 60 days prior to the screening visit. However, if a plug comes out during the study it must be promptly replaced.Have clinical findings of severe Meibomian Gland Dysfunction (MGD) in the Study EyeAre pregnant or breast feedingUse of any investigational product or device within 28 days prior to the Screening Visit or during the study
Processed Prediction
1. Amended Eligibility Criteria (version 3):
1. Provide written informed consent
2. Male or female subjects aged 18 to 80 years, inclusive
3. Have a history of dry eye disease (DED) in both eyes
4. Be on stable regimens of other needed medications
5. Have a BCVA of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS)
6. Report symptoms
7. Have a Schirmer score without anesthesia of >1 and <10 mm at 5 minutes in both eyes and have staining of conjunctival and corneal areas of the eye
8. Have normal lid anatomy
9. Have a serum potassium level at Screening Visit (Visit 1) of 1.1 times the normal upper limit
10. Have any clinically significant, uncontrolled, or unstable medical or surgical conditions that could affect his or her ability to participate in the study or potentially compromise his or her well-being during the study
11. Have not taken any of the excluded medications within 14 days of Screening or during the study
12. Are not pregnant or breast feeding
13. Use of any investigational product or device within 28 days prior to the Screening Visit or during the study
1. Have undergone refractive eye surgery
2. Have undergone previous eyelid surgery in either eye
3. Have lid irregularities or deformities
4. Have a history of glaucoma, a history of an elevated IOP within the past year, or an IOP in either eye > 25 mmHg at the Screening Visit (Visit 1)
5. Have any clinically significant, uncontrolled, or unstable medical or surgical conditions that could affect his or her ability to participate in the study
6. Have permanent punctal plugs, punctal occlusion, or history of nasolacrimal duct obstruction. Removable punctal plugs are allowed if they have been used regularly for at least 60 days prior to the screening visit. However, if a plug comes out during the study it must be promptly replaced.
7. Have clinical findings of severe Meibomian Gland Dysfunction (MGD) in the Study Eye
8. Have required treatment with LipiFlow®, MeiboFlow®, or Blephex™ use within the past 3 months
9. Have a history of Stevens-Johnson syndrome, ocular cicatricial pemphigoid (OCP), or other ocular cicatrizing disorders
10. Have a history of exposure keratopathy, neurotrophic keratopathy, lagophthalmos, or trichiasis
11. Have used contact lenses within 28 days of Visit 1 or anticipate needing to use contacts during the study
12. Have used lid scrubs (including baby shampoos) in the past 28 days
13. Have a known hypersensitivity or allergy to the study investigational medicinal product, or formulation excipients, including amiloride or related drugs
14. Have taken within 14 days of Screening or will need to take any of the following medications during the study:
15. Any topical prescription or over-the-counter (OTC) ocular medication including topical cyclosporine (e.g. Restasis®), lifitegrast (Xiidra®), or topical anti-glaucoma medications
16. Ocular, intranasal or systemic corticosteroids or other immunomodulatory or immunosuppressive medications
17. Topical ocular or systemic antibiotics, including doxycycline or tetracycline analogs
18. Oral or topical secretagogues such as pilocarpine and cevimeline (Evoxac®)
19. Systemic medications with known significant anticholinergic pharmacologic activity as referenced in the Prohibited Medication List for the study, such as tricyclic antidepressants. Selective Serotonin Re-uptake Inhibitors (SSRIs) are permitted if patient is on stable dose for 28 days prior to Visit 1 and during the study
20. The following medications are explicitly excluded for 14 days prior to Randomization Visit and throughout the study:
21. Nasal, ocular, or oral antihistamines
22. NSAIDs (non-steroidal anti-inflammatory drugs) or aspirin use with the exception of low dose (81mg) aspirin per day
23. Topical autologous serum
24. Lubricant eye drops
25. Are an employee of the site that is directly involved in the management, administration, or support of this study or be an immediate family member of the same
26. Are unable in the opinion of the PI to comply fully with the study requirements or to complete the study
27. Have taken within 14 days of Screening or will need to take any of the following medications during the study:
28. Any topical prescription or OTC ocular medication including topical cyclosporine (e.g. Restasis®), lifitegrast (Xiidra®), or topical anti-glaucoma medications
29. Ocular, intranasal or systemic corticosteroids or other immunomodulatory or immunosuppressive medications
30. Topical ocular or systemic antibiotics, including doxycycline or tetracycline analogs
31. Oral or topical secretagogues such as pilocarpine and cevimeline (Evoxac®)
32. Systemic medications with known significant anticholinergic pharmacologic activity as referenced in the Prohibited Medication List for the study, such as tricyclic antidepressants. Selective Serotonin Re-uptake Inhibitors (SSRIs) are permitted if patient is on stable dose for 28 days prior to Visit 1 and during the study
33. Have taken within 14 days of Screening or will need to take any of the following medications during the study:
34. Any topical prescription or OTC ocular medication including topical cyclosporine (e.g. Restasis®), lifitegrast (Xiidra®), or topical anti-glaucoma medications
35. Ocular, intranasal or systemic corticosteroids or other immunomodulatory or immunosuppressive medications
36. Topical ocular or systemic antibiotics, including doxycycline or tetracycline analogs
37. Oral or topical secretagogues such as pilocarpine and cevimeline (Evoxac®)
38. Systemic medications with known significant anticholinergic pharmacologic activity as referenced in the Prohibited Medication List for the study, such as tricyclic antidepressants. Selective Serotonin Re-uptake Inhibitors (SSRIs) are permitted if patient is on stable dose for 28 days prior to Visit 1 and during the study