A Multicenter, Randomized, Double-blind Phase Ⅲ Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group 12 Weeks After Treatment in Moderate to Severe Dry Eye Disease
The purpose of this clinical Study is Tisporin Eye Drops 0.05%(Cyclosporine ophthalmic solution) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group 12 weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety in Moderate to Severe Dry Eye Disease. \- Corneal staining test, Ocular surface disease index (OSDI), Tear break up time (TBUT), Non-anesthetic Schirmer test
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
1 drop twice/day for 12 weeks to both eyes
The catholic university of Korea seoul st. Mary's hospital
Seoul, Seocho-Ku, South Korea
Corneal staining test
The degree of staining of the cornea after blue fluorescein staining under the slit lamp illumination of a cobalt blue light source using a yellow filter was evaluated on a 6 point scale according to the oxford grading system
Time frame: Administered 12 weeks after
Tear break up time (TBUT)
After blinking blue fluorescein staining of the cobalt blue light source using a yellow filter, it was observed from the blinking point that there was a black spot, a streak pattern or a fluorine defect in the fluorescein-tear layer Was measured in seconds. The measurement results were repeated three times and average values were used.
Time frame: Administered 4, 8, 12 weeks after
Corneal staining test
Corneal staining was performed at each visit. The degree of staining of the cornea after blue fluorescein staining under the slit lamp illumination of a cobalt blue light source using a yellow filter was evaluated on a 6 point scale according to the oxford grading system
Time frame: Administered 4, 8 weeks after
Ocular surface disease index (OSDI)
The ocular surface disease index was assessed for ocular surface disease, including visual function (five items), eye symptoms (four items), and environmental factors (three items) , 0 point for no symptoms, 1 point for occasional symptoms, 2 points for symptoms of half a day, 3 points for most symptoms, and 4 points for symptoms during the whole day.
Time frame: Administered 4, 8, 12 weeks after
Non-anesthetic Schirmer test
After the eyes were examined, the eyes were wiped and the Schirmer test paper was inserted into the right eye at 1/3 of the lower eyelid without eye anesthesia and inserted into the left eye. After 5 minutes with the eyes closed, the Schirmer test paper was removed from the right side in the order of insertion and the left side removed. The wet length was measured in millimeters and the length of the midpoint was measured when the wet border was oblique.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Administered 4, 8, 12 weeks after
Conjunctival staining
After lysamine green staining under slit lamps, the conjunctiva was divided into the nasal side and the lateral side, and the degree of nasal conjunctiva and bilateral conjunctival staining was evaluated on a 6-point scale according to the oxford grading system
Time frame: Administered 4, 8, 12 weeks after