Do You Have Glaucoma or Ocular Hypertension? Join a New Medication Study

A research study involving human subjects is designed to answer specific questions about the safety and/or efficacy of an intervention (drug, treatment, device, or other products), or new ways of using a known drug, treatment, device, or product before or during an investigational drug or product is made available to the public.

There are common assessments that are performed during most clinical studies. Here is what you can expect during this study:

1. Read and sign the Informed Consent Form (ICF)

• The ICF explains the study in more detail. The study doctor will explain the information in the ICF and answer any questions. 
• You must sign the ICF before receiving any study treatment or assessments. 
• Remember that taking part in the study is your choice. You can stop at any time. 

2. Confirm that you can join the study

Participants who would like to join the study will undergo screening to ensure they are a good fit. Study assessments/procedures may include: 

• Demographics: You will be asked to provide personal information, including date of birth, gender, ethnic origins, and race. 
• Medical History: You will be asked about your past and present health conditions, including glaucoma or ocular hypertension. You must provide accurate and complete information about your medical history and present health conditions. 
• Health Exams: You will have eye exams, pressure checks, vision tests, and eye imaging.

3. Health Assessments and Monitoring

At scheduled visits, the research team will:

• You’ll be given study eye drops in one eye only, with the other eye continuing its usual care.
• At visits, you’ll have eye exams, pressure checks, vision tests, and eye imaging.
• Doctors may also check your general health with blood work, blood pressure, and routine safety assessments.
• You may be asked to temporarily pause your current glaucoma drops during a short “washout period,” if your doctor says it’s safe

Clinic: Eye Surgery Associates – East Melbourne
Address: Level 2,232 Victoria Parade, East Melbourne VIC 3002

Clinic: Melbourne Eye Specialists
Address: Suite C27, Lvl 2, 41 Victoria Parade, Fitzroy VIC 3065

Clinic: Sydney Eye Surgeons

Addresses:

Park Place

Suite 606b, Level 6

3 Waverley St

Bondi Junction NSW 2022

Suite 12, Level 2

33 McMahon St

Hurstville NSW 2220

Level 1

629 Kingsway

Miranda NSW 2228

Study Duration

• The total study duration is approximately 4 to 6 weeks.
  The investigational eye drops or a comparison eye drop are administered once daily for 3 days in one eye only (the eye with lower vision, or the left eye if vision is the same).

Study Visits

• Screening Visit (before the study officially begins; includes eye exams and eligibility checks)
• Washout Period (for those currently taking eye pressure drops, 2–4 weeks long, if your doctor says it’s safe)
• Baseline Visit (Day 1, first dose)
• Treatment Period Visits (Days 2 and 3, with daily dosing and exams)
• End-of-Treatment/Exit Visit (Day 4)

Visits are scheduled closely together to allow researchers to carefully monitor eye health, treatment safety, and study results while minimizing the overall study length.

No, you do not have to pay to participate in a clinical study.

• It does not cost participants any money to join this clinical study, and they do not need health insurance to join.
• The study-related treatment and study visits will be of no cost to participants or their insurance companies.

Yes. You may decide to stop taking part in the study at any time and without providing any reason.