Ocular Hypertension, Primary Open-angle Glaucoma
Conditions
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.
Interventions
DRUGLX7101 (0.125%)
Subjects will receive 0.125% LX7101
DRUGLX7101 (0.25%)
Subjects will receive 0.25% LX7101
DRUGLX7101 Vehicle
Subjects will receive vehicle
Sponsors
Lexicon Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects experiencing an adverse event | 15 Days |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed