NCT01528111

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

5 active sites

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

February 3, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2012

Completed
23 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 14, 2015

Status Verified

August 1, 2015

Enrollment Period

3 months

First QC Date

February 3, 2012

Last Update Submit

August 31, 2015

Conditions

Primary Open-angle GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Number of subjects experiencing an adverse event

    15 Days

Secondary Outcomes (3)

  • Mean Intraocular Pressure (IOP) in the study eye

    Days 1, 3, 7, 10, 14, 15

  • Best Corrected Visual Acuity (BCVA)

    Days 1, 3, 7, 10, 14, 15

  • Slit lamp biomicroscopy exam (SLE)

    Days 1, 3, 7, 10, 14, 15

Study Arms (3)

Low dose LX7101

EXPERIMENTAL

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)

Drug: LX7101 (0.125%)

High dose LX7101

EXPERIMENTAL

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)

Drug: LX7101 (0.25%)

LX7101 Vehicle

PLACEBO COMPARATOR

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)

Drug: LX7101 Vehicle

Interventions

LX7101 (0.125%)DRUG

Subjects will receive 0.125% LX7101

Low dose LX7101
LX7101 (0.25%)DRUG

Subjects will receive 0.25% LX7101

High dose LX7101
LX7101 VehicleDRUG

Subjects will receive vehicle

LX7101 Vehicle

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Lexicon Investigational Site

Morrow, Georgia, 30260, United States

Location

Lexicon Investigational Site

Memphis, Tennessee, 38119, United States

Location

Lexicon Investigational Site

Austin, Texas, 78731, United States

Location

Lexicon Investigational Site

Houston, Texas, 77025, United States

Location

Lexicon Investigational Site

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

LX-7101

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Study Officials

  • Joel Freiman, M.D., MPH

    Lexicon Pharmaceuticals, Inc.

    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

February 3, 2012

First Posted

February 7, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 14, 2015

Record last verified: 2015-08

Locations

US(5)