Clinical trial NCT01528111: Study to Evaluate the Safety, Tolerability, and Efficacy of LX7101 in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Primary Open-angle Glaucoma
Ocular Hypertension
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-02-07
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects experiencing an adverse event
timeFrame: 15 Days
Secondary outcomes:
measure: Mean Intraocular Pressure (IOP) in the study eye
timeFrame: Days 1, 3, 7, 10, 14, 15
measure: Best Corrected Visual Acuity (BCVA)
timeFrame: Days 1, 3, 7, 10, 14, 15
measure: Slit lamp biomicroscopy exam (SLE)
timeFrame: Days 1, 3, 7, 10, 14, 15
Other outcomes:
Locations:
city: Morrow
country: United States
facility: Lexicon Investigational Site
state: Georgia
city: Memphis
country: United States
facility: Lexicon Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Houston
country: United States
facility: Lexicon Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Lexicon Investigational Site
state: Texas
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Joel Freiman, M.D., MPH
role: STUDY_DIRECTOR
References: