4 STUDY DESIGN
4.1 Study Overview
Insert a very short description of the study. For example:
This is a single center, double-blind, placebo-controlled, randomized, incomplete block, 3 period crossover trial. XX (number) of subjects are planned. Each subject will be administered a single dose of study drug three times, one week apart, consisting each time of various doses of active or placebo. Each subject will receive three of the four experimental treatments. Subjects will be assigned to the treatments in random order. Evaluations will be taken at baseline and 4 hours at each of the 3 study visits.
Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
The following treatment regimens will be used:
Experimental treatment XXX at the following doses 0.2%, 0.4% or 0.8%
Placebo or Comparator – XXXX
Total duration of subject participation will be three weeks. Total duration of the study is expected to be 10 weeks.
5 CRITERIA FOR EVALUATION
5.1 Primary Efficacy Endpoint
Enter primary endpoint - generally whatever the study was powered on. (May also want to include a brief statement about why the endpoint is appropriate.). Include the time course for which the endpoint will be assessed (i.e. from baseline to end of treatment)
5.2 Secondary Efficacy Endpoints
Enter all secondary efficacy endpoints (ditto on why endpoints are appropriate)
6 SUBJECT SELECTION
6.1 Study Population