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

Primary Purpose

Primary Open-angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LX7101 (0.125%)
LX7101 (0.25%)
LX7101 Vehicle
Sponsored by
Lexicon Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open-angle Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Low dose LX7101

High dose LX7101

LX7101 Vehicle

Arm Description

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)

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)

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)

Outcomes

Primary Outcome Measures

Number of subjects experiencing an adverse event

Secondary Outcome Measures

Mean Intraocular Pressure (IOP) in the study eye
Best Corrected Visual Acuity (BCVA)
Slit lamp biomicroscopy exam (SLE)

Full Information

First Posted
February 3, 2012
Last Updated
August 31, 2015
Sponsor
Lexicon Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01528111
Brief Title
Study to Evaluate the Safety, Tolerability, and Efficacy of LX7101 in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
Official Title
A Phase 1/2a, Randomized, Parallel-group, Double-masked, Vehicle-controlled, Dose-frequency Escalation Study to Evaluate the Safety, Tolerability, and Intraocular Pressure (IOP)-Lowering Efficacy of Topically Administered LX7101 in Subjects Diagnosed With Primary Open-angle Glaucoma (POAG) or Ocular Hypertension (OHT)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lexicon Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose LX7101
Arm Type
Experimental
Arm Description
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)
Arm Title
High dose LX7101
Arm Type
Experimental
Arm Description
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)
Arm Title
LX7101 Vehicle
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
LX7101 (0.125%)
Intervention Description
Subjects will receive 0.125% LX7101
Intervention Type
Drug
Intervention Name(s)
LX7101 (0.25%)
Intervention Description
Subjects will receive 0.25% LX7101
Intervention Type
Drug
Intervention Name(s)
LX7101 Vehicle
Intervention Description
Subjects will receive vehicle
Primary Outcome Measure Information:
Title
Number of subjects experiencing an adverse event
Time Frame
15 Days
Secondary Outcome Measure Information:
Title
Mean Intraocular Pressure (IOP) in the study eye
Time Frame
Days 1, 3, 7, 10, 14, 15
Title
Best Corrected Visual Acuity (BCVA)
Time Frame
Days 1, 3, 7, 10, 14, 15
Title
Slit lamp biomicroscopy exam (SLE)
Time Frame
Days 1, 3, 7, 10, 14, 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Freiman, M.D., MPH
Organizational Affiliation
Lexicon Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Lexicon Investigational Site
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Lexicon Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Lexicon Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Lexicon Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Lexicon Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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