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OpenTrials
Completed

NCT Number: NCT01123772

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

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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Key information

Conditions

Health

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Evansville, Indiana, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INO-8875

Drug

eye drops for 14 days in one eye

Placebo control

Other

Matched placebo

Primary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Inotek Pharmaceuticals Corporation

Industry

Registry information

Official study title

Phase I, Randomized, Double-Masked, Placebo-Controlled, Dose-Escalation Study to Evaluate Tolerability, Safety & PK of BID Topical Ocular Application of INO-8875 in Healthy Older-Adult Volunteers

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 14, 2010
Registry last updated
Apr 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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