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

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)

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Primary Open-angle Glaucoma
• Intervention / Treatment: Drug: LX7101 (0.125%); Drug: LX7101 (0.25%); Drug: LX7101 Vehicle

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Lexicon Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Lexicon Investigational Site
  • Texas
    • Austin, Texas, United States, 78731
      • Lexicon Investigational Site
    • Houston, Texas, United States, 77025
      • Lexicon Investigational Site
    • San Antonio, Texas, United States, 78209
      • Lexicon Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: LX7101 (0.125%); Subjects will receive 0.125% LX7101
Experimental: 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)	Drug: LX7101 (0.25%); Subjects will receive 0.25% LX7101
Placebo Comparator: 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)	Drug: LX7101 Vehicle; Subjects will receive vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of subjects experiencing an adverse event	15 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Lexicon Pharmaceuticals
• Investigators: Study Director: Joel Freiman, M.D., MPH, Lexicon Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: February 3, 2012
• First Submitted That Met QC Criteria: February 3, 2012
• First Posted (Estimate): February 7, 2012

Study Record Updates

• Last Update Posted (Estimate): September 14, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
• Other Study ID Numbers: LX7101.7-101-OAG; LX7101.101 (Other Identifier: Lexicon Pharmaceuticals, Inc.)