Primary Open-angle GlaucomaPhase 1/2NCT01528111
Study to Evaluate the Safety, Tolerability, and Efficacy of LX7101 in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
A Phase 1/2 study testing LX7101 (0.125%) and LX7101 (0.25%) in people with Primary Open-angle Glaucoma and Ocular Hypertension, run by Lexicon Pharmaceuticals at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open-angle Glaucoma, Ocular Hypertension
- What is being tested?
- LX7101 (0.125%) and LX7101 (0.25%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2012to Jun 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age
- Documented diagnosis of POAG or OHT, in both eyes
- Willing and able to provide written informed consent
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Lexicon Investigational Site
Austin, Texas, 78731
Lexicon Investigational Site
Houston, Texas, 77025
Lexicon Investigational Site
Memphis, Tennessee, 38119
Lexicon Investigational Site
Morrow, Georgia, 30260
Lexicon Investigational Site
San Antonio, Texas, 78209
About this study
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)
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.
- Conditions
- Primary Open-angle Glaucoma, Ocular Hypertension
- Being tested
- LX7101 (0.125%), LX7101 (0.25%), LX7101 Vehicle
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LX7101 (0.125%)Drug
Subjects will receive 0.125% LX7101
LX7101 (0.25%)Drug
Subjects will receive 0.25% LX7101
LX7101 VehicleDrug
Subjects will receive vehicle
| Study group | Role | What they receive |
|---|---|---|
| Low dose LX7101 | Experimental | 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) Receives: Drug: LX7101 (0.125%) |
| High dose LX7101 | Experimental | 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) Receives: Drug: LX7101 (0.25%) |
| LX7101 Vehicle | Placebo comparator | 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) Receives: Drug: LX7101 Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects experiencing an adverse event
Measured: 15 Days
Secondary outcomes (3)
Mean Intraocular Pressure (IOP) in the study eye
Measured: Days 1, 3, 7, 10, 14, 15
Best Corrected Visual Acuity (BCVA)
Measured: Days 1, 3, 7, 10, 14, 15
Slit lamp biomicroscopy exam (SLE)
Measured: Days 1, 3, 7, 10, 14, 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open-angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel Freiman, M.D., MPH, Study director, Lexicon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528111
- Sponsor's protocol ID
- LX7101.7-101-OAG
- Other IDs
- LX7101.101
- Status last verified
- Aug 2015
- First submitted
- 3 Feb 2012
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01528111
- Acronym / sponsor ID
- LX7101.7-101-OAG
- Conditions
- Primary Open-angle Glaucoma, Ocular Hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 7 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose LX7101 | Experimental | Drug: LX7101 (0.125%)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) |
| High dose LX7101 | Experimental | Drug: LX7101 (0.25%)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) |
| LX7101 Vehicle | Placebo comparator | Drug: LX7101 VehicleDays 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥18 years of age
- Documented diagnosis of POAG or OHT, in both eyes
- Willing and able to provide written informed consent
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LX7101 (0.125%)Subjects will receive 0.125% LX7101 | Drug | Low dose LX7101 |
| LX7101 (0.25%)Subjects will receive 0.25% LX7101 | Drug | High dose LX7101 |
| LX7101 VehicleSubjects will receive vehicle | Drug | LX7101 Vehicle |
Primary outcome
Number of subjects experiencing an adverse event
Time frame: 15 Days
3 secondary outcomes
Mean Intraocular Pressure (IOP) in the study eye
Time frame: Days 1, 3, 7, 10, 14, 15
Best Corrected Visual Acuity (BCVA)
Time frame: Days 1, 3, 7, 10, 14, 15
Slit lamp biomicroscopy exam (SLE)
Time frame: Days 1, 3, 7, 10, 14, 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Freiman, M.D., MPH study director
Lexicon Pharmaceuticals, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LX7101 (0.125%) and LX7101 (0.25%) in people with Primary Open-angle Glaucoma and Ocular Hypertension, run by Lexicon Pharmaceuticals at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects experiencing an adverse event (time frame: 15 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2015.