A Randomized Phase I Dose-Escalation Study Designed to Evaluate the Tolerability, Safety, and PK of Topical Ocular INO-8875 in Healthy Older-Adult Volunteers - NCT01123772-(Clinical Trial 650112)
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Evansville |
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IN |
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| Conditions: |
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Health |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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 |
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| Study is available at: |
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Evansville, IN
United States
Primary Contact:
Tiffany Crowell
Email: tcrowell@inotekcorp.com
Phone: 781-676-2100 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
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