The Germinal Peptide Eye Drops in Healthy Volunteers in a Clinical Study (NCT03967548) | Clinical Trial Compass
CompletedPhase 1
The Germinal Peptide Eye Drops in Healthy Volunteers in a Clinical Study
China106 participantsStarted 2021-04-09
Plain-language summary
The subjects of this study were healthy subjects, who were given medicine in a single dose group: 0.004%.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. healthy volunteers aged between 18 and 45, both male and female in each group;
. body mass index between 19 and 26 kg/m2 (including critical value), male weight 50 kg, female weight 45 kg;
. target eye Schirmer Ⅰ test (Schirmer filter paper bending, clip next eyelid medial 1/3 conjunctival sac within 5 min) tear wet filter paper length or greater 10 mm;
. subjects will participate in the study voluntarily and sign the informed consent.
Exclusion criteria
. binocular corrected vision \< 1.0, abnormal intraocular pressure, slit lamp and fundus examination with clinical significance;
. those with abnormal physical examination, vital signs, electrocardiogram and laboratory examination before the test with clinical significance;
. patients with eye diseases, including history of inner eye surgery or laser surgery;
. a medical history of central nervous system, spirit, cardiovascular system, kidney, liver, respiratory system, metabolism system and skeletal muscle system, which may endanger the safety of subjects or affect the results of the study;
. positive test results of hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (hcv-ab), treponema pallidum specific antibody (tp-ab) or human immunodeficiency virus antibody (hiv-p24 /Ab);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. have a significant history of clinical allergy, especially drug allergy, especially allergic to any component of germinal peptide eye drops;
. smoking more than 5 cigarettes per day on average;
. those who are suspected or have alcohol dependence, and their alcohol intake is more than 2 units per day on average for 3 months (1 unit =10 mL ethanol, that is, 1 unit =200 mL beer with 5% alcohol or 25 mL spirit with 40% alcohol or 83 mL wine with 12% alcohol) or who have tested positive for alcohol;