Study to Evaluate the Safety, Tolerability, and Efficacy of LX7101 in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
Primary Open-angle Glaucoma, Ocular Hypertension
About this trial
This is an interventional treatment trial for Primary Open-angle Glaucoma
Eligibility 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
Sites / Locations
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Low dose LX7101
High dose LX7101
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)
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)
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)