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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Ocular Hypertension, Primary Open-angle Glaucoma

Intervention / Treatment
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* Drug: LX7101 (0.125%)
* Drug: LX7101 (0.25%)
* Drug: LX7101 Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose LX7101<br>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%)<br>* Subjects will receive 0.125% LX7101<br>|
| Experimental: High dose LX7101<br>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%)<br>* Subjects will receive 0.25% LX7101<br>|
| Placebo Comparator: LX7101 Vehicle<br>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<br>* Subjects will receive vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects experiencing an adverse event |  | 15 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |