Study to Evaluate the Safety, Tolerability, and Efficacy of LX7101 in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-06-30

Brief Summary

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This Phase 1/2a study is intended to assess the safety, tolerability, and effects on intraocular pressure of two dose levels and two dose frequencies of LX7101 when administered topically in the eyes of patients diagnosed with primary open-angle glaucoma or ocular hypertension.

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Detailed Description

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Conditions

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Primary Open-angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Low dose LX7101

Days 1-3: once daily dose in study eye (eye with highest IOP); Days 4-7: once daily dose in study eye (eye with highest IOP) and fellow eye (other eye); Days 8-14: twice daily dose in study eye (eye with highest IOP) and fellow eye (other eye)

Group Type EXPERIMENTAL

LX7101 (0.125%)

Intervention Type DRUG

Subjects will receive 0.125% LX7101

High dose LX7101

Days 1-3: once daily dose in study eye (eye with highest IOP); Days 4-7: once daily dose in study eye (eye with highest IOP) and fellow eye (other eye); Days 8-14: twice daily dose in study eye (eye with highest IOP) and fellow eye (other eye)

Group Type EXPERIMENTAL

LX7101 (0.25%)

Intervention Type DRUG

Subjects will receive 0.25% LX7101

LX7101 Vehicle

Days 1-3: once daily dose in study eye (eye with highest IOP); Days 4-7: once daily dose in study eye (eye with highest IOP) and fellow eye (other eye); Days 8-14: twice daily dose in study eye (eye with highest IOP) and fellow eye (other eye)

Group Type PLACEBO_COMPARATOR

LX7101 Vehicle

Intervention Type DRUG

Subjects will receive vehicle

Interventions

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LX7101 (0.125%)

Subjects will receive 0.125% LX7101

Intervention Type DRUG

LX7101 (0.25%)

Subjects will receive 0.25% LX7101

Intervention Type DRUG

LX7101 Vehicle

Subjects will receive vehicle

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults ≥18 years of age
* Documented diagnosis of POAG or OHT, in both eyes
* Willing and able to provide written informed consent

Exclusion Criteria

* History of any form of glaucoma in either eye, other than POAG
* Subjects who are unwilling or unable to discontinue contact lens wear prior to and during study
* History of ocular trauma in either eye \<6 months prior to Screening
* History of ocular infection or ocular inflammation in either eye \<3 months prior to Screening
* History of chronic or recurrent severe inflammatory eye disease, any severe ocular pathology, or clinically relevant or progressive retinal diseases in either eye
* Clinically relevant, severe central visual field loss, or documented significant progression of a visual field defect within 6 months prior to Screening in either eye
* Use of any ocular hypertensive medications (if applicable), in either eye, during the washout period and for the duration of the study
* Use of any glucocorticoid medications \<2 weeks prior to Screening and throughout the duration of the study
* Use of any medication or substance on a chronic basis which has not been taken at a stable dose for at least 30 days prior to Screening
* Use of any nondiagnostic, topical, ophthalmic preparations, in either eye, other than artificial tears
* The presence of any concurrent condition or clinically significant laboratory findings at Screening that may interfere with any aspect of safety, study conduct, or interpretation of results
* Women who are pregnant or breast feeding
* Inability or difficulty instilling eye drops

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No