NCT00443924

Brief Summary

The purpose of this trial is to evaluate the safety and tolerability of INS115644 Ophthalmic Solution in subjects with bilateral ocular hypertension or early primary open angle glaucoma and to investigate the intraocular pressure lowering effects of INS115644 Ophthalmic Solution.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2007

Typical duration for phase_1

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

2.1 years

First QC Date

March 5, 2007

Last Update Submit

January 19, 2015

Conditions

Ocular HypertensionOpen Angle Glaucoma

Keywords

Bilateral ocular hypertension or early primary open angle glaucoma

Outcome Measures

Primary Outcomes (2)

  • Safety and tolerability

    28 days

  • Changes in intraocular pressure

    28 days

Study Arms (5)

1

PLACEBO COMPARATOR

Arm 1

Drug: Placebo

2

EXPERIMENTAL

Arm 2

Drug: INS115644 Ophthalmic Solution

3

EXPERIMENTAL

Arm 3

Drug: INS115644 Ophthalmic Solution

4

EXPERIMENTAL

Arm 4

Drug: INS115644 Ophthalmic Solution

5

EXPERIMENTAL

Arm 5

Drug: INS115644 Ophthalmic Solution

Interventions

INS115644 Ophthalmic SolutionDRUG

One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for three days

2
PlaceboDRUG

One drop of placebo in each eye every 12 hours for three days

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a diagnosis of bilateral ocular hypertension or early primary open angle glaucoma
  • Have best corrected visual acuity in both eyes of at least +0.5 or better
  • Have normal endothelial cell counts and morphology

You may not qualify if:

  • Are diagnosed with closed angle glaucoma, exfoliation syndrome or exfoliation glaucoma, and pigment dispersion or secondary glaucoma
  • Have a history of any type of intraocular surgery, except for cataract surgery
  • Have had cataract surgery within three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ocular HypertensionGlaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Eye DiseasesGlaucoma

Study Design

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

Study Record Dates

First Submitted

March 5, 2007

First Posted

March 7, 2007

Study Start

March 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

January 21, 2015

Record last verified: 2015-01