It requires a great deal of work, time and money to bring a new drug product to market. In fact, it takes on average 12 years and over $350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes around three and a half years of laboratory testing before an application is made to the U.S. Food and Drug Administration (FDA) to begin testing the drug in humans. Only one in a thousand of the compounds that enter laboratory testing ever make it to human testing. If the FDA gives the green light, the drug under investigation then enters three phases of clinical trials:

• Phase 1 uses 20-80 healthy volunteers to establish a drug's safety and profile. This process takes about a year.
• Phase 2 employs 100-300 patient volunteers to assess the drug's effectiveness. This process takes about two years.
• Phase 3 involves 1000-3000 patients in clinics and hospitals who are monitored carefully to determine the drug's effectiveness and identify adverse reactions. This process takes about three years.¹

Current clinical trials approved by the National Institutes of Health can be accessed at the NIH Clinical Trial website, http://clinicaltrials.gov. A recent search of that database using the term "dry eye" revealed there were 395 current trials related to dry eye disease. While that sounds like a large number, consider there are 8200 current studies in diabetes, 4444 studies in hypertension, and 20932 studies of cardiovascular disease, to name a few. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available.

Reviewing some of the dry eye clinical trials did show some interesting tidbits (as do the ARVO abstracts, which we'll talk about in a few months). There is a tremendous amount of work being done with oral nutritional supplements in dry eye. Twelve studies are currently underway assessing the effect of omega 3 supplements in dry eye. The same can be said for cyclosporine. There are 33 studies in the database evaluating cyclosporine, either alone or in concert with other medications. There are clinical trials underway using the current medications that are available to determine if one is better than another in the treatment of dry eye. Anti-inflammatories in the treatment of dry eye is another area of interest. There are 20 studies evaluating the use of both steroidal and non-steroidal anti-inflammatories in dry eye. Two studies are evaluating the use of autologous serum in treating the disease, and there was even a study that evaluates the use of acupuncture in the treatment of dry eye.²

Time does not permit me to discuss all the clinical trials underway, nor would you want that unless you are having trouble with insomnia. But from reviewing the clinical trials, I think a couple of points can be gleaned. First, dry eye is a huge clinical concern, one that continues to garner the attention of ophthalmic drug companies. And second, while pharmaceutical companies attempt to improve our current treatment modalities, we do have a tremendous number of treatment options at our disposal. Except acupuncture. I'll hold off recommending that until I see the results of the clinical trial!

REFERENCES
1. www.drugs.com. Accessed 4/4/2012.
2. Kim TH, Kim JI, Shin MS, et al. Acupuncture for dry eye: a randomized controlled trial protocol. Trials 2009; Dec 3;10:112.