Acute Anterior UveitisPhase 2NCT02482129
Proof of Concept Study to Evaluate Safety and Efficacy of LME636 in the Treatment of Acute Anterior Uveitis
A Phase 2 study testing LME636 60 mg/mL ophthalmic solution and Dexamethasone 0.1% ophthalmic solution in people with Acute Anterior Uveitis, run by Alcon Research.
Trial summary
The purpose of the study is to determine whether topical ocular administration of LME636 60 mg/mL is efficacious in resolving the ocular inflammation in the anterior chamber (AC) associated with acute anterior uveitis (AAU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Anterior Uveitis
- What is being tested?
- LME636 60 mg/mL ophthalmic solution and Dexamethasone 0.1% ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 17 Jul 2015to 21 Mar 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Provide written informed consent.
- Diagnosis of non-infectious AAU in at least 1 eye.
- Anterior chamber cell score of 2+ or 3+ as per Standardization of Uveitis Nomenclature (SUN) in at least one eye.
- Able to communicate well with the Investigator, to understand and comply with the requirements of the study.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Women of child-bearing potential unwilling to use effective contraception methods as defined in the protocol.
- AC cell score of 4+ (SUN) or hypopyon.
- Onset of anterior uveitis more than 2 weeks prior to enrollment in the study.
- Presence of intermediate-, posterior-, or panuveitis in either eye.
- Administration of stable doses >10 mg daily systemic prednisone or corticosteroids as described in the protocol.
- Recurrent corneal abrasion or ulceration in either eye (past or present).
- Tuberculosis (past or present).
- Other protocol-specified exclusion criteria may apply.
About this study
Official title: A Multicenter, Randomized, Double-Masked, Active-Controlled Study to Evaluate the Safety and Efficacy of LME636 in Patients With Acute Anterior Uveitis
The purpose of the study is to determine whether topical ocular administration of LME636 60 mg/mL is efficacious in resolving the ocular inflammation in the anterior chamber (AC) associated with acute anterior uveitis (AAU).
Read the detailed description
Eligible subjects will be randomized to LME636 or Dexamethasone in a 3:1 ratio at the time they present to the trial site with the AAU flare and will enter treatment for 28 full days. Subjects with worsening disease from Visit 2/Day 4 onward or subjects without improvement after 14 days of treatment will be discontinued from treatment, unmasked and treated with a rescue regimen at the discretion of the investigator.
- Conditions
- Acute Anterior Uveitis
- Being tested
- LME636 60 mg/mL ophthalmic solution, Dexamethasone 0.1% ophthalmic solution, LME636 Vehicle
- Keywords
- Acute anterior uveitis, LME636
- Medical subject headings
- Uveitis, Anterior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LME636 60 mg/mL ophthalmic solutionDrug
Dexamethasone 0.1% ophthalmic solutionDrug
LME636 VehicleDrug
Inactive ingredients used for masking purposes
| Study group | Role | What they receive |
|---|---|---|
| LME636 | Experimental | LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4) Receives: Drug: LME636 60 mg/mL ophthalmic solution; Drug: LME636 Vehicle |
| Dexamethasone | Active comparator | Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4) Receives: Drug: Dexamethasone 0.1% ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Responders at Day 15
Response was defined as a two-step decrease or more from baseline in Anterior Chamber (AC) Cell Grade as per Standardization of Uveitis Nomenclature (SUN). Baseline was defined as the measurement taken before drug administration on Day 1. Subjects receiving rescue treatment on or before Day 15 were considered non-responders. Only one eye contributed to the analysis.
Measured: Baseline (Day 1), Day 15
Mean Best Corrected Visual Acuity (BCVA) at Each Visit
Visual Acuity (VA) with the subject's best spectacles or other visual corrective devices was measured using an Early Treatment of Diabetic Retinopathy Study (ETDRS) or Snellen visual acuity chart and reported in letters read correctly. An increase (gain) in letters read indicates improvement. Only one eye contributed to the analysis.
Measured: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
Mean Intraocular Pressure (IOP) at Each Visit
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry or Tonopen and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.
Measured: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit
Slit-lamp biomicroscopy (examination) was performed to evaluate the anterior segment of the eye, including lids/lashes, conjunctiva, cornea, anterior chamber (cells and flare), iris, and lens. Ocular signs were categorized as Aqueous Flare, Aqueous Inflammatory Cell Grade, Keratic Precipitates, Lens, Limbal Injection, Status of Lens, Peripheral Anterior Synechia, and Posterior Synechia. An increase indicates worsening. Only one eye contributed to the analysis.
Measured: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
Number of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment Visit
The dilated fundus examination was performed to evaluate the health of the vitreous, optic disc, retinal vessels, macula, and retinal periphery. An increase indicates worsening. Only one eye contributed to the analysis.
Measured: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
Secondary outcomes (6)
Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment
IOP was assessed using Goldmann applanation tonometry or Tonopen and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.
Measured: Baseline (Day 1), Up to Day 29
Mean Change From Baseline in BCVA at Each Visit
Visual Acuity (VA) was measured with the participant's best spectacles or other visual corrective device in place using an ETDRS or Snellen visual acuity chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. Only one eye contributed to the analysis.
Measured: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
Time-to-Response
Time-to-Response was defined as the number of days from baseline to the first scheduled visit when a two-step decrease or more from baseline in AC Cell Grade (as per SUN) was observed. Time-to-Response is reported as number of subjects presenting time-to-response by visit. Only one eye contributed to the analysis.
Measured: Baseline (Day 1), Up to Day 15
Use of Rescue Treatment
Use of rescue treatment is presented as the number of subjects with first use of rescue treatment by visit. Subjects receiving rescue medication were not considered withdrawn and the collection of data continued after discontinuation of study treatment. Only one eye contributed to the analysis.
Measured: Day 4, Day 8, Day 15
Mean Serum Concentration of Total LME636 at Each Visit
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. Concentrations below the limit of quantification (BLQ), defined as 0.25 ng/mL, were reported as NA with no imputation for missing data.
Measured: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
Number of Subjects With Anti-LME636 Antibodies Present at Each Visit
Serum samples were collected and assessed for anti-LME636 antibodies. Samples collected from subjects in the LME636 dose group were analyzed for anti-LME636 antibodies. For subjects in the dexamethasone group, only the samples collected on Day 1 (ie, prior to the start of treatment) were analyzed for anti-LME636 antibodies.
Measured: Day 1, Day 4, Day 8, Day 15, Day 22, Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study start17 Jul 2015
- Primary completion21 Mar 2016
- Study completion21 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Anterior UveitisStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Scientist NIBR, Alcon, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482129
- Sponsor's protocol ID
- LME636-2201
- Status last verified
- Jul 2017
- First submitted
- 23 Jun 2015
- Last updated
- 2 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Masked, Active-Controlled Study to Evaluate the Safety and Efficacy of LME636 in Patients With Acute Anterior Uveitis
- ClinicalTrials.gov ID
- NCT02482129
- Acronym / sponsor ID
- LME636-2201
- Conditions
- Acute Anterior Uveitis
- Keywords
- Acute anterior uveitis, LME636
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2015 (actual)
- Primary completion
- 21 Mar 2016 (actual)
- Study completion
- 21 Mar 2016 (actual)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Posted 28 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether topical ocular administration of LME636 60 mg/mL is efficacious in resolving the ocular inflammation in the anterior chamber (AC) associated with acute anterior uveitis (AAU).
Detailed description
Eligible subjects will be randomized to LME636 or Dexamethasone in a 3:1 ratio at the time they present to the trial site with the AAU flare and will enter treatment for 28 full days. Subjects with worsening disease from Visit 2/Day 4 onward or subjects without improvement after 14 days of treatment will be discontinued from treatment, unmasked and treated with a rescue regimen at the discretion of the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LME636 | Experimental | Drug: LME636 60 mg/mL ophthalmic solution, Drug: LME636 VehicleLME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4) |
| Dexamethasone | Active comparator | Drug: Dexamethasone 0.1% ophthalmic solutionDexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provide written informed consent.
- Diagnosis of non-infectious AAU in at least 1 eye.
- Anterior chamber cell score of 2+ or 3+ as per Standardization of Uveitis Nomenclature (SUN) in at least one eye.
- Able to communicate well with the Investigator, to understand and comply with the requirements of the study.
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (8 listed)
- Women of child-bearing potential unwilling to use effective contraception methods as defined in the protocol.
- AC cell score of 4+ (SUN) or hypopyon.
- Onset of anterior uveitis more than 2 weeks prior to enrollment in the study.
- Presence of intermediate-, posterior-, or panuveitis in either eye.
- Administration of stable doses >10 mg daily systemic prednisone or corticosteroids as described in the protocol.
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 |
|---|---|---|
| LME636 60 mg/mL ophthalmic solution | Drug | LME636 |
| Dexamethasone 0.1% ophthalmic solution | Drug | Dexamethasone |
| LME636 VehicleInactive ingredients used for masking purposes | Drug | LME636 |
Primary outcome
Number of Responders at Day 15
Time frame: Baseline (Day 1), Day 15
Response was defined as a two-step decrease or more from baseline in Anterior Chamber (AC) Cell Grade as per Standardization of Uveitis Nomenclature (SUN). Baseline was defined as the measurement taken before drug administration on Day 1. Subjects receiving rescue treatment on or before Day 15 were considered non-responders. Only one eye contributed to the analysis.
Mean Best Corrected Visual Acuity (BCVA) at Each Visit
Time frame: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
Visual Acuity (VA) with the subject's best spectacles or other visual corrective devices was measured using an Early Treatment of Diabetic Retinopathy Study (ETDRS) or Snellen visual acuity chart and reported in letters read correctly. An increase (gain) in letters read indicates improvement. Only one eye contributed to the analysis.
Mean Intraocular Pressure (IOP) at Each Visit
Time frame: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry or Tonopen and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.
Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit
Time frame: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
Slit-lamp biomicroscopy (examination) was performed to evaluate the anterior segment of the eye, including lids/lashes, conjunctiva, cornea, anterior chamber (cells and flare), iris, and lens. Ocular signs were categorized as Aqueous Flare, Aqueous Inflammatory Cell Grade, Keratic Precipitates, Lens, Limbal Injection, Status of Lens, Peripheral Anterior Synechia, and Posterior Synechia. An increase indicates worsening. Only one eye contributed to the analysis.
Number of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment Visit
Time frame: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
The dilated fundus examination was performed to evaluate the health of the vitreous, optic disc, retinal vessels, macula, and retinal periphery. An increase indicates worsening. Only one eye contributed to the analysis.
6 secondary outcomes
Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment
Time frame: Baseline (Day 1), Up to Day 29
Mean Change From Baseline in BCVA at Each Visit
Time frame: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
Time-to-Response
Time frame: Baseline (Day 1), Up to Day 15
Use of Rescue Treatment
Time frame: Day 4, Day 8, Day 15
Mean Serum Concentration of Total LME636 at Each Visit
Time frame: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
Number of Subjects With Anti-LME636 Antibodies Present at Each Visit
Time frame: Day 1, Day 4, Day 8, Day 15, Day 22, Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Scientist NIBR, Alcon study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LME636 60 mg/mL ophthalmic solution and Dexamethasone 0.1% ophthalmic solution in people with Acute Anterior Uveitis, run by Alcon Research.
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 5 inclusion and 8 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 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 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?
Yes. Results are posted in the registry (first posted 28 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Responders at Day 15 (time frame: Baseline (Day 1), Day 15). The study lists 5 primary outcomes in all. 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 2 Jul 2018; AzTrials last refreshed its copy on 6 Nov 2026.