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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

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.

Condition or disease Intervention/treatment Phase
Primary Open-angle Glaucoma Ocular Hypertension Drug: LX7101 (0.125%) Drug: LX7101 (0.25%) Drug: LX7101 Vehicle Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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




Primary Outcome Measures :
  1. Number of subjects experiencing an adverse event [ Time Frame: 15 Days ]

Secondary Outcome Measures :
  1. Mean Intraocular Pressure (IOP) in the study eye [ Time Frame: Days 1, 3, 7, 10, 14, 15 ]
  2. Best Corrected Visual Acuity (BCVA) [ Time Frame: Days 1, 3, 7, 10, 14, 15 ]
  3. Slit lamp biomicroscopy exam (SLE) [ Time Frame: Days 1, 3, 7, 10, 14, 15 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01528111


Locations
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United States, Georgia
Lexicon Investigational Site
Morrow, Georgia, United States, 30260
United States, Tennessee
Lexicon Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Lexicon Investigational Site
Austin, Texas, United States, 78731
Lexicon Investigational Site
Houston, Texas, United States, 77025
Lexicon Investigational Site
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
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Study Director: Joel Freiman, M.D., MPH Lexicon Pharmaceuticals, Inc.

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Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01528111     History of Changes
Other Study ID Numbers: LX7101.7-101-OAG
LX7101.101 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
First Posted: February 7, 2012    Key Record Dates
Last Update Posted: September 14, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases