Keratoconjunctivitis SiccaPhase 1NCT00851734
A Dose-Escalation Study to Assess the Safety and Tolerability of LX214 Ophthalmic Solution in Healthy Volunteers, Followed by an Open-Label Evaluation of LX214 in Patients With Keratoconjunctivitis Sicca (KCS)
A Phase 1 study testing voclosporin ophthalmic solution in people with Keratoconjunctivitis Sicca, run by Lux Biosciences, Inc. at 1 site in United States.
Trial summary
This is a first-in-man study for the purpose of determining the safety and tolerability of LX214 ophthalmic solution in healthy volunteers and in patients with dry eye syndrome. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratoconjunctivitis Sicca
- What is being tested?
- voclosporin ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Apr 2009
- Phase
- Phase 1
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No systemic disease as determined by a physical examination, clinical laboratory evaluation, and an ECG
- Schirmer's I Test ≥ 10mm/5 minutes with anesthesia
- Corrected Snellen acuity of 20/40 or better in both eyes
Who cannot join
- Subjects diagnosed with any ocular disease other than refraction error
- Subjects with intraocular pressure >21 mmHg
- Use of a contact lens within 7 days prior to administration of the first dose
- Subjects with history of ocular surgery
- Subjects with a history of laser refractive surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Product Investigations
Conshohocken, Pennsylvania, 19428
About this study
Official title: A Phase 1 Dose-Escalation Study To Assess the Safety and Tolerability of LX214 Ophthalmic Solution in Healthy Volunteers, Followed By an Open-Label Evaluation of LX214 Ophthalmic Solution in Patients With Keratoconjunctivitis Sicca
This is a first-in-man study for the purpose of determining the safety and tolerability of LX214 ophthalmic solution in healthy volunteers and in patients with dry eye syndrome.
- Conditions
- Keratoconjunctivitis Sicca
- Being tested
- voclosporin ophthalmic solution
- Medical subject headings
- Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
voclosporin ophthalmic solutionDrug
0.02%, 0.2% t.i.d. or b.i.d.
| Study group | Role | What they receive |
|---|---|---|
| LX214 0.02% | Experimental | LX214 ophthalmic solution 0.02% Receives: Drug: voclosporin ophthalmic solution |
| LX214 0.2% | Experimental | Not described Receives: Drug: voclosporin ophthalmic solution |
| placebo | Placebo comparator | placebo Receives: Drug: voclosporin ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
ocular irritation
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratoconjunctivitis SiccaStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lux Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851734
- Sponsor's protocol ID
- LX214-01
- Status last verified
- Jun 2012
- First submitted
- 24 Feb 2009
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-Escalation Study To Assess the Safety and Tolerability of LX214 Ophthalmic Solution in Healthy Volunteers, Followed By an Open-Label Evaluation of LX214 Ophthalmic Solution in Patients With Keratoconjunctivitis Sicca
- ClinicalTrials.gov ID
- NCT00851734
- Acronym / sponsor ID
- LX214-01
- Conditions
- Keratoconjunctivitis Sicca
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Lux Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 26 Feb 2009 (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 is a first-in-man study for the purpose of determining the safety and tolerability of LX214 ophthalmic solution in healthy volunteers and in patients with dry eye syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LX214 0.02% | Experimental | Drug: voclosporin ophthalmic solutionLX214 ophthalmic solution 0.02% |
| LX214 0.2% | Experimental | Drug: voclosporin ophthalmic solution |
| placebo | Placebo comparator | Drug: voclosporin ophthalmic solutionplacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- No systemic disease as determined by a physical examination, clinical laboratory evaluation, and an ECG
- Schirmer's I Test ≥ 10mm/5 minutes with anesthesia
- Corrected Snellen acuity of 20/40 or better in both eyes
Key exclusion criteria (5 listed)
- Subjects diagnosed with any ocular disease other than refraction error
- Subjects with intraocular pressure >21 mmHg
- Use of a contact lens within 7 days prior to administration of the first dose
- Subjects with history of ocular surgery
- Subjects with a history of laser refractive surgery
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 |
|---|---|---|
| voclosporin ophthalmic solution0.02%, 0.2% t.i.d. or b.i.d. | Drug | LX214 0.02%, LX214 0.2%, placebo |
Primary outcome
ocular irritation
Time frame: 12 hours
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 22 Jun 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing voclosporin ophthalmic solution in people with Keratoconjunctivitis Sicca, run by Lux Biosciences, Inc. at 1 site 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 5 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 22 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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?
ocular irritation (time frame: 12 hours). 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 22 Jun 2012.