Study of INS115644 Ophthalmic Solution in Subjects With Ocular Hypertension or Glaucoma

A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Ascending Dose Study of INS115644 Ophthalmic Solution in Subjects With Bilateral Ocular Hypertension or Early Primary Open Angle Glaucoma

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00443924

Enrollment

Registered

2007-03-07

Start date

2007-03-31

Completion date

2009-04-30

Last updated

2015-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Open Angle Glaucoma

Keywords

Bilateral ocular hypertension or early primary open angle glaucoma

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.

Interventions

DRUGINS115644 Ophthalmic Solution

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability	28 days
Changes in intraocular pressure	28 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026