• The study compound is an eye drop solution that may potentially be used for the treatment of severe eye surface inflammatory diseases These conditions are caused by strong immune responses (for example, following a stem cell transplant). This can lead to dryness, redness, irritation, blurred vision, and ultimately even scarring or permanent loss of vision. It is thought that the study compound can reduce inflammation and subsequently cause relief of the eye symptoms of these diseases.
• The first entry in the research center will be preceded by one short visit. During this short visit, an eye examination (which is a part of the medical screening) will be conducted. The eye examination will be repeated during your stay in the research center and at the follow-up visit.

Tested more frequently:

The compound has already been tested in healthy individuals and patients as an oral solution. In these clinical trials, the following side-effects were observed most often: stomach pain, mouth sores, acid reflux, nausea, headaches and dizziness. During this trial, the compound will be tested in humans for the first time in the form of eye drops. Close attention will therefore be paid to how participants respond to the eye drops.  The eye drop solution has been extensively tested in the laboratory and on animals. There have been no observed side effects in animal testing using the study compound as an eye drop solution.

You may also experience other, yet unknown, side effects. Prior to the medical screening, you will receive written information about the trial, which also describes the possible side effects. This information will also be discussed with you at the start of the medical screening. You can then ask the screening physician or nurse any questions you may have. Once everything is clear to you, you can decide whether to give written consent to participate in the trial. The medical screening will only take place after you have given written consent to participate in the trial. We want to emphasize that even after giving written consent, participation in any clinical trial is voluntary. You can decide at any time not to participate or to stop the medical screening or the trial. You do not need to provide a reason for why you no longer wish to participate.

• You are a healthy male or female.
• You are at least 18 and at most 55 years old.
• Your weight is at least 50 kg and at most 110 kg and your Body Mass Index (BMI) is at least 18.5 and at most 29.9 kg/m². 
• Both non-smokers and light smokers or occasional smokers (max 5 cigarettes per day) are allowed to participate in this clinical trial. During your stay in our research facility, you are not allowed to smoke.
• You can only participate in this trial when you have good vision in both eyes. This can be with or without glasses. In addition, it is important that you have not undergone any eye surgeries, have any previous or ongoing eye conditions and that you do not have blurred or partial vision in either eye. You are not allowed to use contact lenses until after the follow-up visit of the trial.

• As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:
  • You are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones) in combination with a condom;
  • You are using a copper intra-uterine device in combination with a condom;
  • You have passed the menopause (no periods for at least 12 months);
  • You have been sterilized or your male partner has been sterilized;
  • You are only sexually active with a partner of the same sex;
  • You are not sexually active according to your lifestyle.
• As a male you can only participate if you meet one of the following conditions:
  • You are using a condom in combination with an additional contraception method used by your female partner;
  • You have been sterilized or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
  • You are only sexually active with a partner of the same sex;
  • You are not sexually active according to your lifestyle.

Note:

• You cannot participate in the trial if you have participated in another clinical trial in the 2 months prior to the first compound administration in this clinical trial (counting from the follow-up visit from the previous trial).
• To determine if you are suitable to participate in this trial, you will undergo a medical screening. Depending on availability, this can be performed in Groningen or in Utrecht.

The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 17 days (16 nights).

The follow-up visit will take place between 4 and 8 days after your departure from the research facility.

Note: You must be available for all dates to be able to participate in this clinical trial.