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

Completed · Phase 1/Phase 2

Conditions studied: Primary Open-angle Glaucoma, Ocular Hypertension

In brief

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.

Key facts

Study ID

NCT01528111

Run by

Lexicon Pharmaceuticals

People needed

63

Starts

2012-03-01

Expected to finish

2012-06-01

Last updated by the study team

2015-09-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults ≥18 years of age
• Documented diagnosis of POAG or OHT, in both eyes
• Willing and able to provide written informed consent

You may not qualify if…

• 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

Where it is running

• Lexicon Investigational Site — Morrow, Georgia, United States
• Lexicon Investigational Site — Memphis, Tennessee, United States
• Lexicon Investigational Site — Austin, Texas, United States
• Lexicon Investigational Site — Houston, Texas, United States
• Lexicon Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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