NCT01123785

Brief Summary

The purpose of this study is to evaluate how tolerable, safe, and effective it is to give INO-8875 eye drops to adults with glaucoma or ocular hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

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
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

October 15, 2012

Status Verified

October 1, 2012

Enrollment Period

1.6 years

First QC Date

April 27, 2010

Last Update Submit

October 11, 2012

Conditions

GlaucomaOcular Hypertension

Keywords

glaucomaocular hypertensionadenosine agonisteye dropprimary open angle glaucoma

Outcome Measures

Primary Outcomes (1)

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

    14 days

Secondary Outcomes (1)

  • Number of Participants with decreased Intra-ocular pressure

    14 days

Study Arms (2)

Control

PLACEBO COMPARATOR

Matched vehicle-control

Drug: Placebo

INO-8875

EXPERIMENTAL

Adenosine agonist eye drop

Drug: INO-8875

Interventions

INO-8875DRUG

eye drops for 14 days in one eye

INO-8875
PlaceboDRUG

Matched vehicle-control

Control

Eligibility Criteria

Age18 Years - 77 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG).
  • Aged 18 to 75 years.
  • Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg.

You may not qualify if:

  • No significant visual field loss or any new field loss within the past year.
  • Cup-to-disc ratio ≥0.8
  • Central corneal thickness \<500 µm or \>600 µm
  • History of adult asthma or chronic obstructive pulmonary disease
  • A recent (acute) or chronic medical condition that might obfuscate the Subject's study data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lugene Eye Institute

Glendale, California, 91205, United States

Location

MeSH Terms

Conditions

GlaucomaOcular HypertensionGlaucoma, Open-Angle

Interventions

INO-8875

Condition Hierarchy (Ancestors)

Eye Diseases

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

December 1, 2011

Study Completion

January 1, 2012

Last Updated

October 15, 2012

Record last verified: 2012-10

Locations

US(1)