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

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Ocular Hypertension; Primary Open-angle Glaucoma

Treatments: Drug: LX7101 (0.25%); Drug: LX7101 Vehicle; Drug: LX7101 (0.125%)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01528111

LX7101.101 (Other Identifier)

LX7101.7-101-OAG

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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63 participants in 3 patient groups, including a placebo group

Low dose LX7101

Experimental group

Description:

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)

Treatment:

Drug: LX7101 (0.125%)

High dose LX7101

Experimental group

Description:

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)

Treatment:

Drug: LX7101 (0.25%)

LX7101 Vehicle

Placebo Comparator group

Description:

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)

Treatment:

Drug: LX7101 Vehicle