Study to Evaluate the Safety, Tolerability, and Efficacy of LX7101 in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
Status: | Completed |
---|---|
Conditions: | High Blood Pressure (Hypertension), Ocular |
Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | March 2012 |
End Date: | June 2012 |
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)
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.
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.
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
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