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

• Sponsor: Lexicon Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01528111
• Collaborator: (none)
• Enrollment: 63
• Locations: 5
• Arms: 3
• Duration (Months): 3
• Patients Per Site: 12.6
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Open-angle Glaucoma; Ocular Hypertension	Drug: LX7101 (0.125%); Drug: LX7101 (0.25%); Drug: LX7101 Vehicle	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Mar 1, 2012
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low dose LX7101 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)	Drug: LX7101 (0.125%); Subjects will receive 0.125% LX7101
Experimental: High dose LX7101 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)	Drug: LX7101 (0.25%); Subjects will receive 0.25% LX7101
Placebo Comparator: LX7101 Vehicle 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)	Drug: LX7101 Vehicle; Subjects will receive vehicle

Outcome Measures

Primary Outcome Measures

1. Number of subjects experiencing an adverse event [15 Days]

Secondary Outcome Measures

1. Mean Intraocular Pressure (IOP) in the study eye [Days 1, 3, 7, 10, 14, 15]

2. Best Corrected Visual Acuity (BCVA) [Days 1, 3, 7, 10, 14, 15]

3. Slit lamp biomicroscopy exam (SLE) [Days 1, 3, 7, 10, 14, 15]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lexicon Investigational Site	Morrow	Georgia	United States	30260
2	Lexicon Investigational Site	Memphis	Tennessee	United States	38119
3	Lexicon Investigational Site	Austin	Texas	United States	78731
4	Lexicon Investigational Site	Houston	Texas	United States	77025
5	Lexicon Investigational Site	San Antonio	Texas	United States	78209

Sponsors and Collaborators

• Lexicon Pharmaceuticals

Investigators

• Study Director: Joel Freiman, M.D., MPH, Lexicon Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lexicon Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01528111
• Other Study ID Numbers: LX7101.7-101-OAG; LX7101.101
• First Posted: Feb 7, 2012
• Last Update Posted: Sep 14, 2015
• Last Verified: Aug 1, 2015

• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension

Study Results

No Results Posted as of Sep 14, 2015