NCT01123772

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2010

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 14, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

April 30, 2012

Status Verified

April 1, 2012

Enrollment Period

9 months

First QC Date

April 27, 2010

Last Update Submit

April 27, 2012

Conditions

Health

Keywords

adenosine agonisteye dropelderly volunteerolder healthy volunteer

Outcome Measures

Primary Outcomes (1)

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

    14 days

Study Arms (2)

Control

PLACEBO COMPARATOR

Vehicle control

Other: Placebo control

INO-8875

EXPERIMENTAL

Active drug

Drug: INO-8875

Interventions

INO-8875DRUG

eye drops for 14 days in one eye

INO-8875
Placebo controlOTHER

Matched placebo

Control

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Evansville, Indiana, United States

Location

MeSH Terms

Interventions

INO-8875

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2010

First Posted

May 14, 2010

Study Start

May 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

April 30, 2012

Record last verified: 2012-04

Locations

US(1)