STUDY DESIGN


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