| Contact Lenses are regulated by the Food and | | | | also pry a little more into the amount of drugs |
| Drug Administration (F.D.A.) as Class 3 Medical | | | | needed to be effective in treatment and what |
| Devices. Class 3 medical devices are defined by | | | | time intervals are needed to administer the |
| the FDA as those that support or sustain human | | | | medication. |
| life, are of substantial importance in preventing | | | | Phase 3 studies are what brings a new drug to |
| impairment of human health, or which present a | | | | the corner pharmacy. Phase 3 trials may base |
| potential, unreasonable risk of illness or injury. | | | | tentative approval on only several hundred |
| Class 3 medical devices require the highest level | | | | patients, and typically no more than 2000-3000 |
| of evidence for market approval which is a | | | | are in this phase. For you, that does mean a 1 in |
| process to evaluate safety and effectiveness | | | | 10,000 lethal effect may not be known initially, or |
| before the product can be brought to market. | | | | some other surprises may not be uncovered for |
| Clinical studies, scientific documentation, and | | | | several years. In Phase 3 patients are split into |
| reviews are required. There can also be post | | | | groups with one group receiving placebos (no |
| marketing surveillance studies after a new contact | | | | active medication) and another group receives the |
| lens is released to look for further problems. | | | | actual medication, Researchers typically don't |
| Prescription drugs require a similar but much more | | | | know who is getting what until the end of the |
| involved process before they reach the market | | | | study. Occasionally, it becomes so evident that a |
| place. | | | | drug is saving lives or vision that the study is |
| A press release from the National Eye Institute in | | | | stopped as it is not ethical to deprive the patients |
| 2008 stated a phase one gene therapy clinical trial | | | | receiving placebos of the full benefits of the new |
| showed promising results for a blinding disease | | | | drug. The Woman's Health Initiative study on |
| known as a congenital form (present at birth) of | | | | hormone replacement therapy for menopause |
| Optic Atrophy. The retinal pigment epithelium is | | | | was an example of this. The study was |
| the layer of the tissue lining the back of the eye, | | | | terminated early when it was determined that |
| the retina, that nourishes the rod and cone cells | | | | hormone therapy increased the risk of breast |
| we see with. A mutation in a retinal pigment | | | | cancer. |
| epithelium gene causes these cells to respond | | | | Phase 4 is where the good, the bad, and the ugly |
| very poorly to light and results in loss of vision. | | | | comes out. This is also called the Post Marketing |
| Frequently we see news on gene therapy and | | | | Surveillance Phase. Phase 4 trials involve the long |
| are led to believe everything will be cured by in | | | | term safety monitoring where the 1 in a million |
| short order. Patients in the study received a | | | | problems start to be seen over time. Also the |
| sub-retinal injection to replace the defective gene | | | | interactions with other medications may become |
| in areas of the retina that were still relatively | | | | more evident, and strange reactions specific to an |
| healthy. Each patient had visual impairment that | | | | individual may appear. Long term effects like the |
| had been present since birth due to the defective | | | | diet drug that caused heart problems may show |
| gene. Over a 90-day period there was significant | | | | up after a number of years. |
| improvement in vision. Day vision was improved | | | | Our Fort Collins office has taken part in several |
| by 50-fold and night vision by 63,000-fold | | | | optometrist clinical studies with contact lenses. |
| compared to levels prior to treatment. Restored | | | | These are somewhat like the phase 3 clinical trials |
| vision was localized to the area of treatment in | | | | for medications. A lens may be studied by eye |
| the eye that received the injection. We tend to | | | | doctors on 500-600 patients prior to approval. |
| think of new drugs and medical devices as | | | | While there is no such thing as a placebo lens, a |
| overnight miracles but researchers have been | | | | contact lenses that has been approved in the past |
| working for 15 years to get to this point. The | | | | can be used on one eye as a comparison control. |
| new generation of 30 day wear contact lenses | | | | It a lot of fun to be involved in these emerging |
| actually started with research done in the 1970's. | | | | contact lens products but also a lot of record |
| All new prescription drugs and medical devices | | | | keeping, and when patients don't keep their |
| face the funding and regulatory structures that | | | | appointments the stipulations are pretty rigid |
| are required to pass the requirements for | | | | about dropping them from the study. Generally |
| approval. While this process is frustrating and | | | | we do not expect the same type of serious |
| fraught with problems, if you spend a little time | | | | complications with contact lenses that can be |
| reading about the equivalent processes and | | | | seen with new medications. |
| equivalent oversight agency in China, you will gain | | | | One final bit of information. Sometimes things |
| a greater appreciation for the system we do | | | | works out in odd ways. While drugs may have |
| have in place. | | | | undergone all 4 phases and have approval for |
| Clinical trials for prescription drugs proceed in four | | | | specific conditions, that does not restrict doctors |
| phases over a period of years and millions of | | | | from using medications "off label" in ways they |
| dollars. Actually there is a new phase zero but | | | | have not been studied and approved for.The Food |
| since it is still in transition we will cover only the 4 | | | | and Drug Administration regulates drugs and |
| main phases. | | | | medical devices, not Doctors. Currently, the |
| The first testing of drugs in humans as referred | | | | standard of care for certain eye infections is "off |
| to as phase one. Typically this involves healthy | | | | label eye drops." It would be considered |
| individuals in a group less than 50. The main goal | | | | substandard care to use the FDA approved |
| of phase one trials are the to make sure there | | | | medication in these special cases. This a very |
| are no glaring safety issues and gain some | | | | uncommon occurrence indicative of some weak |
| understanding of how the drug works and is | | | | point in the system where clinical experience is |
| processed in the body. Normally, a small (20-50) | | | | ahead of the curve. Someday there will be a way |
| group of healthy volunteers will be selected. | | | | to account for these situations. Until then, we will |
| Phase 2 trials are mostly just an extension of | | | | continue to do the best with what we know |
| phase one with several hundred patients. They | | | | today. |