Trial · NCT02482129

Proof of Concept Study to Evaluate Safety and Efficacy of LME636 in the Treatment of Acute Anterior Uveitis

NCT02482129, Phase 2, Completed, Alcon Research; results first posted 2017-08-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Proof of Concept Study to Evaluate Safety and Efficacy of LME636 in the Treatment of Acute Anterior Uveitis. Trials, record NCT02482129. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02482129

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Proof of Concept Study to Evaluate Safety and Efficacy of LME636 in the Treatment of Acute Anterior Uveitis
NCT number: NCT02482129
Status: Completed
Phases: Phase 2
Enrollment: 45 participants, actual
Lead sponsor: Alcon Research
Conditions: Acute Anterior Uveitis
Interventions: LME636 60 mg/mL ophthalmic solution, Dexamethasone 0.1% ophthalmic solution, LME636 Vehicle
First posted: 2015-06-26
Last updated: 2018-07-02
Results first posted: 2017-08-28

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Responders at Day 15	Baseline (Day 1), Day 15	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).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Mean Best Corrected Visual Acuity (BCVA) at Each Visit	Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29	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.	letters	MEAN
PRIMARY	Mean Intraocular Pressure (IOP) at Each Visit	Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29	Safety Analysis Set. Number Analyzed is the number of subjects with data at visit.	mmHg	MEAN
PRIMARY	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	Safety Analysis Set	participants	NUMBER
PRIMARY	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	Safety Analysis Set	participants	NUMBER
SECONDARY	Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment	Baseline (Day 1), Up to Day 29	Safety Analysis Set	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mean Change From Baseline in BCVA at Each Visit	Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29	Safety Analysis Set. Number Analyzed is the number of subjects with data at visit.	letters	MEAN
SECONDARY	Time-to-Response	Baseline (Day 1), Up to Day 15	Per Protocol Analysis Set	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Use of Rescue Treatment	Day 4, Day 8, Day 15	Per Protocol Analysis Set	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mean Serum Concentration of Total LME636 at Each Visit	Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29	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.	ng/mL	MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group105

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Responders at Day 15	LME636		14		Participants
Number of Responders at Day 15	Dexamethasone		9		Participants
Mean Best Corrected Visual Acuity (BCVA) at Each Visit	LME636	Baseline	71.1	Standard Deviation 14.58	letters
Mean Best Corrected Visual Acuity (BCVA) at Each Visit	Dexamethasone	Baseline	77.2	Standard Deviation 14.69	letters
Mean Best Corrected Visual Acuity (BCVA) at Each Visit	LME636	Day 4	70.5	Standard Deviation 13.92	letters
Mean Best Corrected Visual Acuity (BCVA) at Each Visit	Dexamethasone	Day 4	77.9	Standard Deviation 12.94	letters
Mean Best Corrected Visual Acuity (BCVA) at Each Visit	LME636	Day 8	72.1	Standard Deviation 13.62	letters
Mean Best Corrected Visual Acuity (BCVA) at Each Visit	Dexamethasone	Day 8	76.8	Standard Deviation 11.50	letters
Mean Best Corrected Visual Acuity (BCVA) at Each Visit	LME636	Day 15	74.1	Standard Deviation 10.11	letters
Mean Best Corrected Visual Acuity (BCVA) at Each Visit	Dexamethasone	Day 15	77.1	Standard Deviation 11.82	letters

1 to 10 of 105Source ClinicalTrials.gov

See all 105 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	LME636	32
Overall Study	STARTED	Dexamethasone	11
Overall Study	Treated, as Randomized	LME636	30
Overall Study	Treated, as Randomized	Dexamethasone	9
Overall Study	COMPLETED	LME636	26
Overall Study	COMPLETED	Dexamethasone	9
Overall Study	NOT COMPLETED	LME636	6
Overall Study	NOT COMPLETED	Dexamethasone	2

Source ClinicalTrials.gov

Adverse events60

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anterior chamber cell	Eye disorders	Pretreatment	0	45
other	Anterior chamber cell	Eye disorders	LME636	4	29
other	Anterior chamber cell	Eye disorders	Dexamethasone	1	10
other	Anterior chamber cell	Eye disorders	Posttreatment	0	39
other	Anterior chamber flare	Eye disorders	Pretreatment	0	45
other	Anterior chamber flare	Eye disorders	LME636	3	29
other	Anterior chamber flare	Eye disorders	Dexamethasone	0	10
other	Anterior chamber flare	Eye disorders	Posttreatment	0	39
other	Ciliary muscle spasm	Eye disorders	Pretreatment	0	45
other	Ciliary muscle spasm	Eye disorders	LME636	0	29

1 to 10 of 60Source ClinicalTrials.gov

See all 60 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pretreatment	0	45
Total, all-cause mortality	LME636	0	29
Total, all-cause mortality	Dexamethasone	0	10
Total, all-cause mortality	Posttreatment	0	39
Total, other adverse events	Pretreatment	0	45
Total, other adverse events	LME636	13	29
Total, other adverse events	Dexamethasone	6	10
Total, other adverse events	Posttreatment	0	39
Total, serious adverse events	Pretreatment	0	45
Total, serious adverse events	LME636	1	29

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
LME636 vs Dexamethasone: Number of Responders at Day 15

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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