Important: Models were tasked with extracting evidence from documents. Some outputs may be low quality and should be scored accordingly.
Your task: Compare the model-generated prediction (right panel) against the ground truth criteria (left panel).
Evaluation scale (0-4):
Consider both content accuracy and completeness. Some predictions may be technically "correct" but incomplete or out of order.
INCLUSION CRITERIA 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. 2. Have normal lid anatomy EXCLUSION CRITERIA 1. 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. 2. Removable punctal plugs are allowed if they have been used regularly for at least 60 days prior to the screening visit. 3. However, if a plug comes out during the study it must be promptly replaced. 4. 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
Amended Eligibility Criteria (version 3): INCLUSION CRITERIA 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 EXCLUSION CRITERIA 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