Assess the Safety and Efficacy of CsA Ophthalmic Gel in Subjects With Dry Eye (NCT03676335) | Clinical Trial Compass
CompletedPhase 2
Assess the Safety and Efficacy of CsA Ophthalmic Gel in Subjects With Dry Eye
China240 participantsStarted 2018-05-09
Plain-language summary
The purpose of this study is to explore the efficacy and safety of CsA ophthalmic gel in the treatment of moderate to severe tear deficiency dry eye with different dosage, frequency and concentration, and to preliminarily determine the optimal dosage, frequency and concentration, so as to provide a theoretical basis for the design of follow-up clinical studies.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Age ā„18, both male and female;
ā. Pregnancy tests were negative for women of childbearing age and contraceptive measures (including abstinence, intrauterine devices, diaphragms and spermicides) were taken during the trial. Men are willing to use approved contraceptive methods (possibly using condoms and spermicides or oral contraceptives, implants or injections of contraceptives, intrauterine devices, diaphragms and spermicides) or sexual partner infertility;
ā. According to the symptoms and signs and ophthalmologic examinations, the patients were diagnosed as moderate to severe dry eye;
ā. EDS score is more than 40 points;
ā. BUT is less than 10 s;
ā. Schirmer test result is less than 10mm/5 min;
ā. In any area, corneal fluorescein staining was more than 2 points.
ā. The anatomy of the eyelids is normal and has normal blinking function;
Exclusion criteria
ā. Allergy to CsA, fluorescein or any component of the drug is known;
ā. Severe dry eye patients requiring surgical treatment;
ā. Glaucoma patients;
ā. Unwilling to avoid wearing contact lenses;
ā
What they're measuring
1
The EDS score at the NO.5 visit was compared with the baseline EDS score (binocular)