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OpenTrials
Completed

NCT Number: NCT01528111

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Lexicon Investigational Site, Morrow, Georgia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LX7101 (0.125%)

Drug

Subjects will receive 0.125% LX7101

LX7101 (0.25%)

Drug

Subjects will receive 0.25% LX7101

LX7101 Vehicle

Drug

Subjects will receive vehicle

Primary outcomes

  1. Number of subjects experiencing an adverse event

    Time frame: 15 Days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Lexicon Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 7, 2012
Registry last updated
Sep 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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