Acute Anterior Uveitis
Conditions
Keywords
Acute anterior uveitis, LME636
Brief 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).
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.
Interventions
DRUGLME636 60 mg/mL ophthalmic solution
DRUGDexamethasone 0.1% ophthalmic solution
DRUGLME636 Vehicle
Inactive ingredients used for masking purposes
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Responders at Day 15 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment | Baseline (Day 1), Up to Day 29 | 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. |
| Mean Change From Baseline in BCVA at Each Visit | Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29 | 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. |
| Time-to-Response | Baseline (Day 1), Up to Day 15 | 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. |
| Use of Rescue Treatment | Day 4, Day 8, Day 15 | 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. |
| Mean Serum Concentration of Total LME636 at Each Visit | Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29 | 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. |
| Number of Subjects With Anti-LME636 Antibodies Present at Each Visit | Day 1, Day 4, Day 8, Day 15, Day 22, Day 29 | 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. |
Participant flow
Recruitment details
Subjects were recruited from 10 study centers located in the United States.
Pre-assignment details
Of the 45 enrolled, 2 subjects were exited as screen failures prior to randomization and 4 subjects were randomized, but not treated. This reporting group includes all randomized subjects, as treated. Note: One subject randomized to LME636 was treated with dexamethasone instead.
Participants by arm
| Arm | Count |
|---|---|
| LME636 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) | 29 |
| Dexamethasone Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4) | 10 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Adverse Event-prior to treatment | 0 | 1 |
| Overall Study | Criteria not met | 1 | 0 |
| Overall Study | Criteria not met-prior to treatment | 1 | 0 |
| Overall Study | Unable to draw blood-prior to treatment | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
| Overall Study | Withdrawal by subject-prior to treatment | 0 | 1 |
Baseline characteristics
| Characteristic | LME636 | Dexamethasone | Total |
|---|---|---|---|
| Age, Continuous | 54.1 years STANDARD_DEVIATION 17.2 | 55.6 years STANDARD_DEVIATION 16.02 | 54.5 years STANDARD_DEVIATION 16.71 |
| Sex: Female, Male Female | 17 Participants | 4 Participants | 21 Participants |
| Sex: Female, Male Male | 12 Participants | 6 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 29 | 0 / 10 | 0 / 39 |
| other Total, other adverse events | 0 / 45 | 13 / 29 | 6 / 10 | 0 / 39 |
| serious Total, serious adverse events | 0 / 45 | 1 / 29 | 0 / 10 | 0 / 39 |
Outcome results
Primary
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.
Time frame: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
Population: This analysis population includes all subjects who received any study drug (Safety Analysis Set). Number Analyzed is the number of subjects with data at visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LME636 | Mean Best Corrected Visual Acuity (BCVA) at Each Visit | Baseline | 71.1 letters | Standard Deviation 14.58 |
| LME636 | Mean Best Corrected Visual Acuity (BCVA) at Each Visit | Day 4 | 70.5 letters | Standard Deviation 13.92 |
| LME636 | Mean Best Corrected Visual Acuity (BCVA) at Each Visit | Day 8 | 72.1 letters | Standard Deviation 13.62 |
| LME636 | Mean Best Corrected Visual Acuity (BCVA) at Each Visit | Day 15 | 74.1 letters | Standard Deviation 10.11 |
| LME636 | Mean Best Corrected Visual Acuity (BCVA) at Each Visit | Day 22 | 74.5 letters | Standard Deviation 10.41 |
| LME636 | Mean Best Corrected Visual Acuity (BCVA) at Each Visit | Day 29 | 73.8 letters | Standard Deviation 11.7 |
| Dexamethasone | Mean Best Corrected Visual Acuity (BCVA) at Each Visit | Day 22 | 78.2 letters | Standard Deviation 11.31 |
| Dexamethasone | Mean Best Corrected Visual Acuity (BCVA) at Each Visit | Baseline | 77.2 letters | Standard Deviation 14.69 |
| Dexamethasone | Mean Best Corrected Visual Acuity (BCVA) at Each Visit | Day 15 | 77.1 letters | Standard Deviation 11.82 |
| Dexamethasone | Mean Best Corrected Visual Acuity (BCVA) at Each Visit | Day 4 | 77.9 letters | Standard Deviation 12.94 |
| Dexamethasone | Mean Best Corrected Visual Acuity (BCVA) at Each Visit | Day 29 | 79.2 letters | Standard Deviation 11.23 |
| Dexamethasone | Mean Best Corrected Visual Acuity (BCVA) at Each Visit | Day 8 | 76.8 letters | Standard Deviation 11.5 |
Primary
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.
Time frame: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
Population: Safety Analysis Set. Number Analyzed is the number of subjects with data at visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LME636 | Mean Intraocular Pressure (IOP) at Each Visit | Baseline (Day 1) | 15.2 mmHg | Standard Deviation 5.09 |
| LME636 | Mean Intraocular Pressure (IOP) at Each Visit | Day 4 | 14.8 mmHg | Standard Deviation 3.74 |
| LME636 | Mean Intraocular Pressure (IOP) at Each Visit | Day 8 | 14.1 mmHg | Standard Deviation 3.4 |
| LME636 | Mean Intraocular Pressure (IOP) at Each Visit | Day 15 | 14.0 mmHg | Standard Deviation 3.38 |
| LME636 | Mean Intraocular Pressure (IOP) at Each Visit | Day 22 | 14.6 mmHg | Standard Deviation 3.14 |
| LME636 | Mean Intraocular Pressure (IOP) at Each Visit | Day 29 | 15.5 mmHg | Standard Deviation 4.72 |
| Dexamethasone | Mean Intraocular Pressure (IOP) at Each Visit | Day 22 | 17.0 mmHg | Standard Deviation 4.57 |
| Dexamethasone | Mean Intraocular Pressure (IOP) at Each Visit | Baseline (Day 1) | 15.5 mmHg | Standard Deviation 4.12 |
| Dexamethasone | Mean Intraocular Pressure (IOP) at Each Visit | Day 15 | 16.0 mmHg | Standard Deviation 5.06 |
| Dexamethasone | Mean Intraocular Pressure (IOP) at Each Visit | Day 4 | 15.3 mmHg | Standard Deviation 3.47 |
| Dexamethasone | Mean Intraocular Pressure (IOP) at Each Visit | Day 29 | 16.3 mmHg | Standard Deviation 4.4 |
| Dexamethasone | Mean Intraocular Pressure (IOP) at Each Visit | Day 8 | 16.1 mmHg | Standard Deviation 3.51 |
Primary
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.
Time frame: Baseline (Day 1), Day 15
Population: This analysis population includes all subjects who received any study drug, had at least 1 post-baseline efficacy assessment, had no critical protocol deviations, and had a valid determination of response status for the primary endpoint (Per Protocol Analysis Set).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LME636 | Number of Responders at Day 15 | 14 Participants |
| Dexamethasone | Number of Responders at Day 15 | 9 Participants |
Primary
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.
Time frame: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LME636 | Number of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment Visit | Macula | 2 participants |
| LME636 | Number of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment Visit | Optic Nerve | 1 participants |
| LME636 | Number of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment Visit | Retina | 1 participants |
| LME636 | Number of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment Visit | Vitreous | 4 participants |
| Dexamethasone | Number of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment Visit | Vitreous | 0 participants |
| Dexamethasone | Number of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment Visit | Macula | 0 participants |
| Dexamethasone | Number of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment Visit | Retina | 0 participants |
| Dexamethasone | Number of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment Visit | Optic Nerve | 0 participants |
Primary
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.
Time frame: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LME636 | Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit | Lens | 0 participants |
| LME636 | Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit | Posterior Synechiae | 8 participants |
| LME636 | Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit | Status of Lens | 0 participants |
| LME636 | Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit | Aqueous Flare | 9 participants |
| LME636 | Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit | Limbal Injection | 7 participants |
| LME636 | Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit | Aqueous Inflammatory Cell Grade | 4 participants |
| LME636 | Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit | Peripheral Anterior Synechia | 1 participants |
| LME636 | Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit | Keratic Precipitates | 4 participants |
| Dexamethasone | Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit | Peripheral Anterior Synechia | 1 participants |
| Dexamethasone | Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit | Lens | 0 participants |
| Dexamethasone | Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit | Limbal Injection | 0 participants |
| Dexamethasone | Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit | Status of Lens | 0 participants |
| Dexamethasone | Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit | Keratic Precipitates | 0 participants |
| Dexamethasone | Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit | Posterior Synechiae | 1 participants |
| Dexamethasone | Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit | Aqueous Flare | 1 participants |
| Dexamethasone | Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit | Aqueous Inflammatory Cell Grade | 1 participants |
Secondary
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.
Time frame: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
Population: Safety Analysis Set. Number Analyzed is the number of subjects with data at visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LME636 | Mean Change From Baseline in BCVA at Each Visit | Baseline (BL) | 71.1 letters | Standard Deviation 14.58 |
| LME636 | Mean Change From Baseline in BCVA at Each Visit | Change from BL at Day 4 | -0.1 letters | Standard Deviation 9.74 |
| LME636 | Mean Change From Baseline in BCVA at Each Visit | Change from BL at Day 8 | 0.0 letters | Standard Deviation 12.84 |
| LME636 | Mean Change From Baseline in BCVA at Each Visit | Change from BL at Day 15 | 2.1 letters | Standard Deviation 9.53 |
| LME636 | Mean Change From Baseline in BCVA at Each Visit | Change from BL at Day 22 | 2.8 letters | Standard Deviation 9.1 |
| LME636 | Mean Change From Baseline in BCVA at Each Visit | Change from BL at Day 29 | 2.1 letters | Standard Deviation 10.36 |
| Dexamethasone | Mean Change From Baseline in BCVA at Each Visit | Change from BL at Day 22 | 1.0 letters | Standard Deviation 5.06 |
| Dexamethasone | Mean Change From Baseline in BCVA at Each Visit | Baseline (BL) | 77.2 letters | Standard Deviation 14.69 |
| Dexamethasone | Mean Change From Baseline in BCVA at Each Visit | Change from BL at Day 15 | -0.1 letters | Standard Deviation 3.73 |
| Dexamethasone | Mean Change From Baseline in BCVA at Each Visit | Change from BL at Day 4 | 0.7 letters | Standard Deviation 5.4 |
| Dexamethasone | Mean Change From Baseline in BCVA at Each Visit | Change from BL at Day 29 | 2.0 letters | Standard Deviation 5.37 |
| Dexamethasone | Mean Change From Baseline in BCVA at Each Visit | Change from BL at Day 8 | -0.4 letters | Standard Deviation 6.19 |
Secondary
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.
Time frame: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
Population: This analysis population includes all subjects who received investigative product (IP) and had at least 1 evaluable serum sample following IP exposure.(Pharmacokinetics Analysis Set). Number Analyzed is the number of subjects with data at visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LME636 | Mean Serum Concentration of Total LME636 at Each Visit | Day 1 | NA ng/mL | — |
| LME636 | Mean Serum Concentration of Total LME636 at Each Visit | Day 4 | NA ng/mL | — |
| LME636 | Mean Serum Concentration of Total LME636 at Each Visit | Day 8 | NA ng/mL | — |
| LME636 | Mean Serum Concentration of Total LME636 at Each Visit | Day 15 | NA ng/mL | — |
| LME636 | Mean Serum Concentration of Total LME636 at Each Visit | Day 22 | 0.2510 ng/mL | Standard Deviation 0.31237 |
| LME636 | Mean Serum Concentration of Total LME636 at Each Visit | Day 29 | NA ng/mL | — |
Secondary
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.
Time frame: Day 1, Day 4, Day 8, Day 15, Day 22, Day 29
Population: This analysis population includes all subjects with available immunogenicity data and no protocol deviations with relevant impact on the data (Immunogenicity Set).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LME636 | Number of Subjects With Anti-LME636 Antibodies Present at Each Visit | Day 8 | 6 Participants |
| LME636 | Number of Subjects With Anti-LME636 Antibodies Present at Each Visit | Day 29 | 18 Participants |
| LME636 | Number of Subjects With Anti-LME636 Antibodies Present at Each Visit | Day 4 | 5 Participants |
| LME636 | Number of Subjects With Anti-LME636 Antibodies Present at Each Visit | Day 1 | 5 Participants |
| LME636 | Number of Subjects With Anti-LME636 Antibodies Present at Each Visit | Day 15 | 11 Participants |
| LME636 | Number of Subjects With Anti-LME636 Antibodies Present at Each Visit | Day 22 | 17 Participants |
| Dexamethasone | Number of Subjects With Anti-LME636 Antibodies Present at Each Visit | Day 1 | 3 Participants |
Secondary
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.
Time frame: Baseline (Day 1), Up to Day 29
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LME636 | Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment | Increase 6-10 mmHg | 0 Participants |
| LME636 | Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment | Decrease 6-10 mmHg | 1 Participants |
| LME636 | Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment | Increase 11-30 mmHg | 1 Participants |
| LME636 | Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment | Decrease 11-30 mmHg | 2 Participants |
| LME636 | Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment | -5 mmHg Decrease - 5 mmHg Increase | 25 Participants |
| LME636 | Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment | Decrease > 30 mmHg | 0 Participants |
| LME636 | Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment | Increase > 30 mmHg | 0 Participants |
| Dexamethasone | Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment | Decrease > 30 mmHg | 0 Participants |
| Dexamethasone | Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment | Increase > 30 mmHg | 0 Participants |
| Dexamethasone | Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment | Increase 11-30 mmHg | 0 Participants |
| Dexamethasone | Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment | Increase 6-10 mmHg | 2 Participants |
| Dexamethasone | Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment | -5 mmHg Decrease - 5 mmHg Increase | 8 Participants |
| Dexamethasone | Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment | Decrease 6-10 mmHg | 0 Participants |
| Dexamethasone | Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment | Decrease 11-30 mmHg | 0 Participants |
Secondary
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.
Time frame: Baseline (Day 1), Up to Day 15
Population: Per Protocol Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LME636 | Time-to-Response | Day 4 | 9 Participants |
| LME636 | Time-to-Response | Day 8 | 5 Participants |
| LME636 | Time-to-Response | Day 15 | 1 Participants |
| LME636 | Time-to-Response | Non-Responder | 10 Participants |
| Dexamethasone | Time-to-Response | Non-Responder | 1 Participants |
| Dexamethasone | Time-to-Response | Day 4 | 7 Participants |
| Dexamethasone | Time-to-Response | Day 15 | 0 Participants |
| Dexamethasone | Time-to-Response | Day 8 | 2 Participants |
Secondary
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.
Time frame: Day 4, Day 8, Day 15
Population: Per Protocol Analysis Set
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LME636 | Use of Rescue Treatment | Day 4 | 3 Participants |
| LME636 | Use of Rescue Treatment | Day 8 | 3 Participants |
| LME636 | Use of Rescue Treatment | Day 15 | 0 Participants |
| LME636 | Use of Rescue Treatment | No Rescue | 19 Participants |
| Dexamethasone | Use of Rescue Treatment | No Rescue | 10 Participants |
| Dexamethasone | Use of Rescue Treatment | Day 4 | 0 Participants |
| Dexamethasone | Use of Rescue Treatment | Day 15 | 0 Participants |
| Dexamethasone | Use of Rescue Treatment | Day 8 | 0 Participants |