Trial Outcomes & Findings for Proof of Concept Study to Evaluate Safety and Efficacy of LME636 in the Treatment of Acute Anterior Uveitis (NCT NCT02482129)
NCT ID: NCT02482129
Last Updated: 2018-07-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Baseline (Day 1), Day 15
Results posted on
2018-07-02
Participant Flow
Subjects were recruited from 10 study centers located in the United States.
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.
Participant milestones
| Measure |
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)
|
Dexamethasone
Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
11
|
|
Overall Study
Treated, as Randomized
|
30
|
9
|
|
Overall Study
COMPLETED
|
26
|
9
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
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)
|
Dexamethasone
Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
|
|---|---|---|
|
Overall Study
Adverse Event-prior to treatment
|
0
|
1
|
|
Overall Study
Withdrawal by subject-prior to treatment
|
0
|
1
|
|
Overall Study
Unable to draw blood-prior to treatment
|
1
|
0
|
|
Overall Study
Criteria not met-prior to treatment
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Criteria not met
|
1
|
0
|
Baseline Characteristics
Proof of Concept Study to Evaluate Safety and Efficacy of LME636 in the Treatment of Acute Anterior Uveitis
Baseline characteristics by cohort
| Measure |
LME636
n=29 Participants
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)
|
Dexamethasone
n=10 Participants
Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 17.20 • n=93 Participants
|
55.6 years
STANDARD_DEVIATION 16.02 • n=4 Participants
|
54.5 years
STANDARD_DEVIATION 16.71 • n=27 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 15Population: 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).
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.
Outcome measures
| Measure |
LME636
n=25 Participants
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)
|
Dexamethasone
n=10 Participants
Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
|
|---|---|---|
|
Number of Responders at Day 15
|
14 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29Population: 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.
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.
Outcome measures
| Measure |
LME636
n=29 Participants
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)
|
Dexamethasone
n=10 Participants
Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
|
|---|---|---|
|
Mean Best Corrected Visual Acuity (BCVA) at Each Visit
Baseline
|
71.1 letters
Standard Deviation 14.58
|
77.2 letters
Standard Deviation 14.69
|
|
Mean Best Corrected Visual Acuity (BCVA) at Each Visit
Day 4
|
70.5 letters
Standard Deviation 13.92
|
77.9 letters
Standard Deviation 12.94
|
|
Mean Best Corrected Visual Acuity (BCVA) at Each Visit
Day 8
|
72.1 letters
Standard Deviation 13.62
|
76.8 letters
Standard Deviation 11.50
|
|
Mean Best Corrected Visual Acuity (BCVA) at Each Visit
Day 22
|
74.5 letters
Standard Deviation 10.41
|
78.2 letters
Standard Deviation 11.31
|
|
Mean Best Corrected Visual Acuity (BCVA) at Each Visit
Day 29
|
73.8 letters
Standard Deviation 11.70
|
79.2 letters
Standard Deviation 11.23
|
|
Mean Best Corrected Visual Acuity (BCVA) at Each Visit
Day 15
|
74.1 letters
Standard Deviation 10.11
|
77.1 letters
Standard Deviation 11.82
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29Population: Safety Analysis Set. Number Analyzed is the number of subjects with data at 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.
Outcome measures
| Measure |
LME636
n=29 Participants
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)
|
Dexamethasone
n=10 Participants
Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
|
|---|---|---|
|
Mean Intraocular Pressure (IOP) at Each Visit
Baseline (Day 1)
|
15.2 mmHg
Standard Deviation 5.09
|
15.5 mmHg
Standard Deviation 4.12
|
|
Mean Intraocular Pressure (IOP) at Each Visit
Day 4
|
14.8 mmHg
Standard Deviation 3.74
|
15.3 mmHg
Standard Deviation 3.47
|
|
Mean Intraocular Pressure (IOP) at Each Visit
Day 8
|
14.1 mmHg
Standard Deviation 3.40
|
16.1 mmHg
Standard Deviation 3.51
|
|
Mean Intraocular Pressure (IOP) at Each Visit
Day 15
|
14.0 mmHg
Standard Deviation 3.38
|
16.0 mmHg
Standard Deviation 5.06
|
|
Mean Intraocular Pressure (IOP) at Each Visit
Day 22
|
14.6 mmHg
Standard Deviation 3.14
|
17.0 mmHg
Standard Deviation 4.57
|
|
Mean Intraocular Pressure (IOP) at Each Visit
Day 29
|
15.5 mmHg
Standard Deviation 4.72
|
16.3 mmHg
Standard Deviation 4.40
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29Population: Safety Analysis Set
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.
Outcome measures
| Measure |
LME636
n=29 Participants
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)
|
Dexamethasone
n=10 Participants
Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
|
|---|---|---|
|
Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit
Posterior Synechiae
|
8 participants
|
1 participants
|
|
Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit
Aqueous Flare
|
9 participants
|
1 participants
|
|
Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit
Aqueous Inflammatory Cell Grade
|
4 participants
|
1 participants
|
|
Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit
Keratic Precipitates
|
4 participants
|
0 participants
|
|
Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit
Lens
|
0 participants
|
0 participants
|
|
Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit
Limbal Injection
|
7 participants
|
0 participants
|
|
Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit
Status of Lens
|
0 participants
|
0 participants
|
|
Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit
Peripheral Anterior Synechia
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29Population: Safety Analysis Set
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.
Outcome measures
| Measure |
LME636
n=29 Participants
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)
|
Dexamethasone
n=10 Participants
Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
|
|---|---|---|
|
Number of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment Visit
Macula
|
2 participants
|
0 participants
|
|
Number of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment Visit
Optic Nerve
|
1 participants
|
0 participants
|
|
Number of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment Visit
Retina
|
1 participants
|
0 participants
|
|
Number of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment Visit
Vitreous
|
4 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Up to Day 29Population: Safety Analysis Set
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.
Outcome measures
| Measure |
LME636
n=29 Participants
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)
|
Dexamethasone
n=10 Participants
Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
|
|---|---|---|
|
Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment
Increase > 30 mmHg
|
0 Participants
|
0 Participants
|
|
Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment
Increase 11-30 mmHg
|
1 Participants
|
0 Participants
|
|
Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment
Increase 6-10 mmHg
|
0 Participants
|
2 Participants
|
|
Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment
-5 mmHg Decrease - 5 mmHg Increase
|
25 Participants
|
8 Participants
|
|
Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment
Decrease 6-10 mmHg
|
1 Participants
|
0 Participants
|
|
Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment
Decrease 11-30 mmHg
|
2 Participants
|
0 Participants
|
|
Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment
Decrease > 30 mmHg
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29Population: Safety Analysis Set. Number Analyzed is the number of subjects with data at 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.
Outcome measures
| Measure |
LME636
n=29 Participants
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)
|
Dexamethasone
n=10 Participants
Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
|
|---|---|---|
|
Mean Change From Baseline in BCVA at Each Visit
Baseline (BL)
|
71.1 letters
Standard Deviation 14.58
|
77.2 letters
Standard Deviation 14.69
|
|
Mean Change From Baseline in BCVA at Each Visit
Change from BL at Day 4
|
-0.1 letters
Standard Deviation 9.74
|
0.7 letters
Standard Deviation 5.40
|
|
Mean Change From Baseline in BCVA at Each Visit
Change from BL at Day 8
|
0.0 letters
Standard Deviation 12.84
|
-0.4 letters
Standard Deviation 6.19
|
|
Mean Change From Baseline in BCVA at Each Visit
Change from BL at Day 15
|
2.1 letters
Standard Deviation 9.53
|
-0.1 letters
Standard Deviation 3.73
|
|
Mean Change From Baseline in BCVA at Each Visit
Change from BL at Day 22
|
2.8 letters
Standard Deviation 9.10
|
1.0 letters
Standard Deviation 5.06
|
|
Mean Change From Baseline in BCVA at Each Visit
Change from BL at Day 29
|
2.1 letters
Standard Deviation 10.36
|
2.0 letters
Standard Deviation 5.37
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Up to Day 15Population: Per Protocol Analysis Set
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.
Outcome measures
| Measure |
LME636
n=25 Participants
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)
|
Dexamethasone
n=10 Participants
Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
|
|---|---|---|
|
Time-to-Response
Day 4
|
9 Participants
|
7 Participants
|
|
Time-to-Response
Day 8
|
5 Participants
|
2 Participants
|
|
Time-to-Response
Day 15
|
1 Participants
|
0 Participants
|
|
Time-to-Response
Non-Responder
|
10 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 4, Day 8, Day 15Population: Per Protocol Analysis Set
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.
Outcome measures
| Measure |
LME636
n=25 Participants
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)
|
Dexamethasone
n=10 Participants
Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
|
|---|---|---|
|
Use of Rescue Treatment
Day 4
|
3 Participants
|
0 Participants
|
|
Use of Rescue Treatment
Day 8
|
3 Participants
|
0 Participants
|
|
Use of Rescue Treatment
Day 15
|
0 Participants
|
0 Participants
|
|
Use of Rescue Treatment
No Rescue
|
19 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29Population: 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.
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.
Outcome measures
| Measure |
LME636
n=29 Participants
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)
|
Dexamethasone
Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
|
|---|---|---|
|
Mean Serum Concentration of Total LME636 at Each Visit
Day 1
|
NA ng/mL
Standard Deviation NA
Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.
|
—
|
|
Mean Serum Concentration of Total LME636 at Each Visit
Day 4
|
NA ng/mL
Standard Deviation NA
Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.
|
—
|
|
Mean Serum Concentration of Total LME636 at Each Visit
Day 8
|
NA ng/mL
Standard Deviation NA
Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.
|
—
|
|
Mean Serum Concentration of Total LME636 at Each Visit
Day 15
|
NA ng/mL
Standard Deviation NA
Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.
|
—
|
|
Mean Serum Concentration of Total LME636 at Each Visit
Day 22
|
0.2510 ng/mL
Standard Deviation 0.31237
|
—
|
|
Mean Serum Concentration of Total LME636 at Each Visit
Day 29
|
NA ng/mL
Standard Deviation NA
Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 4, Day 8, Day 15, Day 22, Day 29Population: This analysis population includes all subjects with available immunogenicity data and no protocol deviations with relevant impact on the data (Immunogenicity Set).
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.
Outcome measures
| Measure |
LME636
n=29 Participants
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)
|
Dexamethasone
n=10 Participants
Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
|
|---|---|---|
|
Number of Subjects With Anti-LME636 Antibodies Present at Each Visit
Day 1
|
5 Participants
|
3 Participants
|
|
Number of Subjects With Anti-LME636 Antibodies Present at Each Visit
Day 4
|
5 Participants
|
—
|
|
Number of Subjects With Anti-LME636 Antibodies Present at Each Visit
Day 8
|
6 Participants
|
—
|
|
Number of Subjects With Anti-LME636 Antibodies Present at Each Visit
Day 15
|
11 Participants
|
—
|
|
Number of Subjects With Anti-LME636 Antibodies Present at Each Visit
Day 22
|
17 Participants
|
—
|
|
Number of Subjects With Anti-LME636 Antibodies Present at Each Visit
Day 29
|
18 Participants
|
—
|
Adverse Events
Pretreatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LME636
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Dexamethasone
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Posttreatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pretreatment
n=45 participants at risk
All subjects who consented to participate in the study prior to initiation of study treatment
|
LME636
n=29 participants at risk
All subjects exposed to LME636 ophthalmic solution
|
Dexamethasone
n=10 participants at risk
All subjects exposed to Dexamethasone ophthalmic solution
|
Posttreatment
n=39 participants at risk
All subjects from the conclusion of treatment until exit from the study
|
|---|---|---|---|---|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
3.4%
1/29 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/39 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
Other adverse events
| Measure |
Pretreatment
n=45 participants at risk
All subjects who consented to participate in the study prior to initiation of study treatment
|
LME636
n=29 participants at risk
All subjects exposed to LME636 ophthalmic solution
|
Dexamethasone
n=10 participants at risk
All subjects exposed to Dexamethasone ophthalmic solution
|
Posttreatment
n=39 participants at risk
All subjects from the conclusion of treatment until exit from the study
|
|---|---|---|---|---|
|
Eye disorders
Anterior chamber cell
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
13.8%
4/29 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/39 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Anterior chamber flare
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
10.3%
3/29 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/39 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Ciliary muscle spasm
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/29 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/39 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Eye irritation
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
6.9%
2/29 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/39 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Eye pain
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
13.8%
4/29 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/39 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
10.3%
3/29 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/39 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Iris adhesions
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
10.3%
3/29 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/39 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Iritis
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/29 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/39 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/29 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/39 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Photophobia
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
10.3%
3/29 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/39 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/29 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/39 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
6.9%
2/29 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/10 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/39 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/29 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/39 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
|
Nervous system disorders
Headache
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
3.4%
1/29 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
10.0%
1/10 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/39 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pretreatment, treatment-emergent, and posttreatment.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
|
Additional Information
Ophthalmology & Medical Lead, Translational Medicine, NIBR
Alcon, A Novartis Division
Phone: 1-888-451-3937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER