Phase I Dose-Escalation Study to Evaluate Tolerability, Safety & PK of INO-8875 in Healthy Older-Adult Volunteers
- Registration Number
- NCT01123772
- Lead Sponsor
- Inotek Pharmaceuticals Corporation
- Brief Summary
The purpose of this study is to evaluate how tolerable and safe it is to give INO-8875 eye drops at different concentrations to normal older healthy adult volunteers for two weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
- male, or a female with a negative pregnancy test and without childbearing potential
- aged 35 to 65 years
- body weight is ≥50 kg and ≤115 kg
Exclusion Criteria
- Subject has glaucoma or any active ophthalmologic disease including conjunctivitis
- Subject has a central retinal vein occlusion in either eye at any time in the past
- Subject is currently on any drug that might affect IOP including oral or ocular glucocorticoids or ephedrine
- Subject has history of ocular trauma or surgery (except for non-incisional surgery performed at least 3 months prior to the Screening visit)
- Subject has a prosthetic eye or any ocular abnormality precluding reliable applanation tonometry in either eye including an immobile pupil.
- Subject is not able to refrain from use of contact lenses during the Treatment Period
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Placebo control Vehicle control INO-8875 INO-8875 Active drug
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events as a Measure of Safety and Tolerability 14 days
- Secondary Outcome Measures
Name Time Method