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

Phase 1

Completed

Interventions: Drug: LX7101 Vehicle
Drug: LX7101 (0.125%)
Drug: LX7101 (0.25%)

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
LX7101 Vehicle	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)
Low dose LX7101	LX7101 (0.125%)	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)
High dose LX7101	LX7101 (0.25%)	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)

Primary Outcome Measures

Name	Time	Method
Number of subjects experiencing an adverse event	15 Days

Secondary Outcome Measures

Name	Time	Method
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