Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease

The OSDI is a questionnaire consisting of 12 questions assessing severity of dry eye using a 5-point scale where 0=none of the time to 4=all of the time. The total score is the sum of the individual scores normalized (standardized) to a severity scale of 0=no symptoms (best score) to 100=maximum severity (worst score). A negative change from Baseline indicated improvement.

The participant rated the severity of their dry eye symptom: dryness using a VAS scale. Participants put a mark on a 100 millimeter line where 0 (far left on the line)=no symptoms to 100 (far right on the line)=most severe symptoms.

Near Visual Acuity was determined using the number of letters read correctly on a low contrast eye chart (gray letters on a white background). An increase in the number of letters read correctly indicated improvement. Much Better is defined as an increase of 10 or more letters read correctly at Day 90 compared to the worse eye at Baseline. Better is defined as an increase of 5 to 9 letters read correctly at Day 90 compared to the worse eye at Baseline.

Near Visual Acuity was determined using the number of letters read correctly on a high contrast eye chart (black letters on a white background). An increase in the number of letters read correctly indicated improvement. Much Better is defined as an increase of 10 or more letters read correctly at Day 90 compared to the worse eye at Baseline. Better is defined as an increase of 5 to 9 letters read correctly at Day 90 compared to the worse eye at Baseline.

TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from Baseline indicated improvement.

The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale where 0=no staining to 5=severe staining over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative number change from baseline represented a decrease in corneal staining (improvement).

The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale where 0=no staining to 5=severe staining over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represented a decrease in the severity of conjunctival staining (improvement).

The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye where Normal=greater than or equal to 10 millimeters (mm) of tears and Dry Eye=less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicated an increase in tears (improvement).