A Study to Investigate the Effect of IOP-lowering With TO-O-1001 Eye Drops in Healthy Subjects and in Patients With Open-Angle Glaucoma or Ocular Hypertension
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Theratocular Biotek Co.
With
Novotech (Australia) Pty Limited
Age
18–59
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
For Healthy Subjects (Parts 1 \& 2)
1. 18 - 59-year-old healthy male or female subjects who are non-lactating and non-pregnant.
2. BMI 18.0\~32.0(kg/m2) and body weight more than 45kg.
3. Intraocular pressure between 10 - 21 mm Hg (inclusive) in each eye.
4. Best-corrected visual acuity (BCVA) in each eye of 20/40 ETRDS or better.
5. The informed consent form has been read, signed and dated by the subjects.
6. Able to communicate well with the investigator and comply with the requirements of the study.
For Patients (Part 3)
1. Must be 18 years of age or older.
2. Diagnosis of primary open angle glaucoma (POAG) or ocular hypertension (OHT).
3. Unmedicated or after washout intraocular pressure (IOP) \>20 mmHg and \< 30 mmHg in study eye at T0 (T0 = 08:00AM\~10:00 AM) of the first qualification visit (Day 1).
4. Best-corrected visual acuity (BCVA) equivalent to 20/200 ETRDS or better.
5. The informed consent form has been read, signed and dated by the subjects.
6. Able to communicate well with the investigator and comply with the requirements of the study
You may not be if
For Healthy Subjects (Parts 1 \& 2)
1. Subjects has chronic or acute ophthalmic disease including glaucoma, macular degeneration, and clinically significant cataract (primary or secondary).
2. Subjects has previous glaucoma intraocular surgery or glaucoma laser procedures within 3 years.
3. Subjects has refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.) within 5 years.
4. Subjects has ocular trauma within the past 6 months, or ocular surgery or laser treatment within the past three months (e.g., laser treatment for glaucoma or retina).
For Patients (Part 3)
1. Closed or very narrow angles (Grade 0-1) or those the investigator judges as occludable and/or with evidence of peripheral anterior synechiae (PAS) ≥ 180 degrees by gonioscopy within 6 months prior to Screening Visit in either eye. (Patent laser iridotomy with Grade 1-2 angles is acceptable in either eye, providing the PAS criteria are still met).
2. Previous glaucoma intraocular surgery in either eye. Prior laser trabeculoplasty (ALT or SLT) in either eye is allowed if performed more than 6 months prior to Screening Visit.
3. Any non-glaucoma intraocular surgery within 3 months prior to Screening Visit in either eye.
4. Participation in a clinical study with use of any investigational drug or treatment within 28 days prior to Baseline (Day 1).
5. Clinically significant abnormalities in: laboratory tests, physical examination, vital signs and/or ECG at Screening Visit. If in the investigator's judgment a subjects with clinically significant abnormalities is appropriate for enrollment in the study, a discussion between the investigator and the Medical Monitor must occur and be documented prior to enrollment of this subjects in the study.
Clareo Health | A Study to Investigate the Effect of IOP-lowering With TO-O-1001 Eye Drops in Healthy Subjects and in Patients With Open-Angle Glaucoma or Ocular Hypertension
