Phase I Dose-Escalation Study to Evaluate Tolerability, Safety & PK of INO-8875 in Healthy Older-Adult Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Health

In brief

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.

Key facts

Study ID

NCT01123772

Run by

Inotek Pharmaceuticals Corporation

People needed

70

Starts

2010-05-01

Expected to finish

2011-02-01

Last updated by the study team

2012-04-30

Who can join

Age: 35 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Evansville, Indiana, United States

Full record on ClinicalTrials.gov

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