NCT00767793

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of INS117548 ophthalmic solution.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_1

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

Study Start

First participant enrolled

September 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 2, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 7, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

October 2, 2015

Status Verified

October 1, 2015

Enrollment Period

8 months

First QC Date

October 2, 2008

Last Update Submit

October 1, 2015

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (4)

  • Incidence of adverse events

    15

  • Rate of discontinuation

    15

  • Changes in: >Ophthalmic exam parameters >Corneal thickness >Intraocular pressure >Visual Acuity >Physical exam, vital signs and laboratory parameters

    15

  • Compliance

    15

Study Arms (4)

Arm 1

PLACEBO COMPARATOR

One drop in each eye every 12 hours for seven days

Drug: Placebo

Arm 2

EXPERIMENTAL

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

Drug: INS117548

Arm 3

EXPERIMENTAL

One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days

Drug: INS117548

Arm 4

EXPERIMENTAL

One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days

Drug: INS117548

Interventions

PlaceboDRUG

One drop in each eye every 12 hours for seven days

Arm 1
INS117548DRUG

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

Arm 2

Eligibility Criteria

Age18 Years - 80 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

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

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Reza Haque, MD, PhD

    Medical Monitor, Inspire

    STUDY DIRECTOR

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

October 2, 2008

First Posted

October 7, 2008

Study Start

September 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

October 2, 2015

Record last verified: 2015-10