Study of ST266 Given by Intranasal Delivery in Glaucoma Suspect Subjects (NCT03901781) | Clinical Trial Compass
CompletedPhase 1
Study of ST266 Given by Intranasal Delivery in Glaucoma Suspect Subjects
United States9 participantsStarted 2019-10-23
Plain-language summary
The primary objective of this trial is to assess the safety of ST266 given by non-invasive intranasal trans-cribriform delivery to glaucoma suspect subjects with ocular hypertension, optic nerve cupping, or family history of glaucoma.
Who can participate
Age range20 Years – 75 Years
SexALL
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Inclusion criteria
✓. Signed Informed Consent Form and HIPAA (Health Insurance Portability and Accountability Act) document.
✓. Male or Female, Ages 20-75 years.
✓. Must be clinically followed as a glaucoma suspect without evidence of glaucomatous damage.
✓. Must have one of the following: 1) IOP ≤ 28 mmHg and at least one (1) IOP measurement \> 21 mmHg, or 2) physiologic cupping of the optic nerve, or 3) a family history of glaucoma.
✓. Two (2) normal visual fields (VF) both Swedish Interactive Threshold Algorithm - Short-wavelength Automated Perimetry (SITA-SWAP) and 24-2 VF prior to subject enrollment at the Baseline Visit.
✓. Two (2) normal Ocular Coherence Tomography (OCT) (of macula and nerve fiber layer) prior to subject enrollment at the Baseline Visit.
✓. Gonioscopy open to at least scleral spur with normal iris configuration.
✓. Normal baseline neuro-cognitive testing.
Exclusion criteria
✕. Females of Child Bearing Potential (FOCBP) who are pregnant or lactating or who will not abstain from sexual activity for 14 days prior to Visit 1, and willing to remain so through 30 days following completion of the subject's first menstrual cycle following the End of Treatment (EOT) Visit. Alternatively, a WOCBP who will not remain abstinent must have been using one of the following acceptable methods of birth control for the times specified:
✕. Unwillingness to submit a urine pregnancy test at screening if of childbearing potential.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
✕. Male subjects who refuse to use one of the following birth control methods:
✕. IOP greater than 29 mmHg in either eye.
✕. Patients with high risk factors of ocular hypertension, such as thin central corneas, as identified by the Principal Investigator who may benefit from earlier treatment will be excluded.
✕. Evidence of Angle closure.
✕. Recent laser or incisional glaucoma surgery.
✕. Subjects who are currently taking glaucoma medications. Subject who can safely stop taking these medications during washout period (4-6 weeks) may be considered.