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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


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
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