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

Ocular Hypertension Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528111
• Other study ID #: LX7101.7-101-OAG
• Secondary ID: LX7101.101
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 3, 2012
• Last updated: August 31, 2015
• Start date: March 2012
• Est. completion date: June 2012

Study information

• Verified date: August 2015
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open-angle Glaucoma

Intervention

Drug:
• LX7101 (0.125%)
Subjects will receive 0.125% LX7101
• LX7101 (0.25%)
Subjects will receive 0.25% LX7101
• LX7101 Vehicle
Subjects will receive vehicle

Locations

Country	Name	City	State
United States	Lexicon Investigational Site	Austin	Texas
United States	Lexicon Investigational Site	Houston	Texas
United States	Lexicon Investigational Site	Memphis	Tennessee
United States	Lexicon Investigational Site	Morrow	Georgia
United States	Lexicon Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects experiencing an adverse event		15 Days	Yes
Secondary	Mean Intraocular Pressure (IOP) in the study eye		Days 1, 3, 7, 10, 14, 15	No
Secondary	Best Corrected Visual Acuity (BCVA)		Days 1, 3, 7, 10, 14, 15	No
Secondary	Slit lamp biomicroscopy exam (SLE)		Days 1, 3, 7, 10, 14, 15	No