| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02365519 | LME636 in the Relief of Persistent Ocular Discomfort in Subjects With Severe Dry Eye Disease | PHASE2 | COMPLETED | 514 | — | — | Mar 9, 2015 | Oct 16, 2015 | Jul 2, 2018 | - | — |
Discomfort frequency and severity (each graded on a separate 100-units scale) were assessed daily using a visual analog scale (VAS) displayed on a handheld digital Pad (electronic patient-reported outcome (ePRO)). Frequency score was in response to the question 'how often your eyes felt uncomfortable during the past 24 hours' ranging from 'Rarely' to 'All the time.' Severity score was in response to the question 'how uncomfortable your eyes felt during the past 24 hours' ranging from 'Very mildly uncomfortable' to 'Very severely uncomfortable.' The Global Ocular Discomfort Score, ranging from 0 to 100, was calculated for any given day, as the square root of the product of the discomfort frequency score multiplied by the discomfort severity score. Improvement results in a reduction of the discomfort frequency or severity, or both, translating into a reduction of the resulting Global Ocular Discomfort score as compared to baseline. A negative change from baseline indicates improvement.
Visual Acuity (VA) with the subject's best spectacles or other visual corrective devices was measured using an ETDRS visual acuity chart at 3 meters (10 feet) and reported in letters read correctly. An increase (gain) in letters read indicates improvement. Both eyes contributed to the analysis.
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry or Tonopen and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Both eyes contributed to the analysis.
Ocular signs (cornea, lens, and iris/anterior chamber) were assessed by slit-lamp biomicroscopy. An increase indicates worsening. Only one eye contributed to the analysis.
The dilated fundus examination was performed to evaluate the health of the vitreous, retina, macula, choroid, and optic nerve. An increase indicates worsening. Only one eye contributed to the analysis.
| Arm | Type | Description |
|---|---|---|
| LME636 | EXPERIMENTAL | LME636 ophthalmic solution, 1 drop (approx. 40 µL; 2.4 mg) administered topically in each eye 3 times a day (TID) for 6 weeks |
| Vehicle | PLACEBO_COMPARATOR | LME636 Vehicle, 1 drop administered topically in each eye TID for 6 weeks |
| Name | Type | Description |
|---|---|---|
| LME636 ophthalmic solution | BIOLOGICAL | - |
| LME636 Vehicle | BIOLOGICAL | Inactive ingredients used as a placebo comparator |
Inclusion Criteria: * Must sign written informed consent. * Physician diagnosis of DED of at least 6 months prior to Visit 1. * Must use artificial tears, gels, lubricants or re-wetting drops on a regular basis. * Respond as "often" or "constantly" to the question "How often do your eyes feel uncom...