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

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ClinicalTrials.gov Identifier: NCT01528111
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : September 14, 2015
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE February 3, 2012
First Posted Date  ICMJE February 7, 2012
Last Update Posted Date September 14, 2015
Study Start Date  ICMJE March 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2012)
Number of subjects experiencing an adverse event [ Time Frame: 15 Days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2012)
  • Mean Intraocular Pressure (IOP) in the study eye [ Time Frame: Days 1, 3, 7, 10, 14, 15 ]
  • Best Corrected Visual Acuity (BCVA) [ Time Frame: Days 1, 3, 7, 10, 14, 15 ]
  • Slit lamp biomicroscopy exam (SLE) [ Time Frame: Days 1, 3, 7, 10, 14, 15 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety, Tolerability, and Efficacy of LX7101 in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Primary Open-angle Glaucoma
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: LX7101 (0.125%)
    Subjects will receive 0.125% LX7101
  • Drug: LX7101 (0.25%)
    Subjects will receive 0.25% LX7101
  • Drug: LX7101 Vehicle
    Subjects will receive vehicle
Study Arms  ICMJE
  • 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)
    Intervention: Drug: LX7101 (0.125%)
  • 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)
    Intervention: Drug: LX7101 (0.25%)
  • 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)
    Intervention: Drug: LX7101 Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2012)
63
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2012)
60
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01528111
Other Study ID Numbers  ICMJE LX7101.7-101-OAG
LX7101.101 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lexicon Pharmaceuticals
Study Sponsor  ICMJE Lexicon Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Joel Freiman, M.D., MPH Lexicon Pharmaceuticals, Inc.
PRS Account Lexicon Pharmaceuticals
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP