Clinical Trial 44450

Andover, MA 01810


Summary:

The purpose of this study is to see how safe an investigational eyedrop OCS-01 (Dexamethasone 1.5%) is and the time it takes for the investigational eye drop to leave your blood stream when given in three different treatment regimens, either 1 time per day, 3 times per day, or 6 times per day. Investigational means that OCS-01 has not been approved by the U.S. Food and Drug Administration (FDA). If you qualify for the study and you decide to join, you will receive OCS-01 eye drops in one eye.

This study consists of 4 office and overnight visits over a period of approximately 6 to 36 days.
Visit 1 may take up to 3 ½ hours
Visit 2 through 4 may take up to 72 hours total (under observation)
 



Each subject must:
1. Be at least 18 and no older than 55 years of age.
2. Be willing able able to provide written informed consent and sign the HIPAA form.
3. Be able and willing to follow all study instructions and attend all study visits.
4. Have good eye health and vision.

5. Must not use illicit drugs.

6. Must not have HIV, Hepatitis B or Hepatitis C.
7.  Have a body weight within 15% of ideal weight.

8. Must not be pregnant or nursing or planning a pregnancy. 

9. Must not have any sensitivities or contraindications (reasons you cannot use the study eye drop) to the use of the study medication or any other medications used in the study (eye drops used for dilation or pressure).

10. Must not have any active systemic or ocular disorder other than refractive disorder.

11. Must not have you had any eye surgeries within three (3) months of Visit 1.

12. Does not have an intraocular lens implant.

13. Have had prior (within 5 days of beginning study treatment), current or anticipated use of contact lenses during study participation.

14. Must not have any abnormality of the lids, ocular surface, or lacrimal (tear) duct system that could affect eye drop absorption.

15. Must be able to comply with a controlled diet during the study period.

16. Must not anticipate an inability to stay at a hotel on required study days.

17. Must not have used any prescription or non-prescription drugs (including vitamins, herbal and dietary supplements, and artificial tears [such as Systane, Blink, etc.]) within 14 days of Visit 1 or anticipate using them.

18. Must not have a history of chronic alcohol consumption exceeding 15 drinks/week for male subjects and 8 drinks/week for female subjects.

19. Must not have a history of drug addiction in the past year or currently using any of the following drugs.


Qualified Participants May Receive:

Up to $2,000 for their time and participation. All meals are provided.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.