Who is sponsoring NCT02482129?

NCT02482129 is sponsored by Alcon Research.

What drugs are being tested in NCT02482129?

Interventions in NCT02482129: LME636 60 mg/mL ophthalmic solution, Dexamethasone 0.1% ophthalmic solution, LME636 Vehicle.

What condition does NCT02482129 study?

NCT02482129 studies Acute Anterior Uveitis.

Is NCT02482129 still recruiting?

NCT02482129 is currently completed. Last updated 2 July 2018.

Are results published for NCT02482129?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-07-02 · How we verify

NCT02482129

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 2 July 2018

What this trial tests

Phase 2 trial testing LME636 60 mg/mL ophthalmic solution in Acute Anterior Uveitis in 45 participants. Completed in 21 March 2016.

Timeline

17 July 2015

Primary endpoint
21 March 2016

21 March 2016

Quick facts

Lead sponsor	Alcon Research
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	45
Start date	17 July 2015
Primary completion	21 March 2016
Estimated completion	21 March 2016

Drugs / interventions tested

LME636 60 mg/mL ophthalmic solution — full drug profile →
Dexamethasone 0.1% ophthalmic solution
LME636 Vehicle — full drug profile →

Conditions studied

Acute Anterior Uveitis — all drugs for Acute Anterior Uveitis →

Sponsor

Alcon Research — full company profile →

Who can join

18 and older, any sex, with Acute Anterior Uveitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Responders at Day 15 Primary · 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.

Group	Value	95% CI
LME636	14
Dexamethasone	9

Mean Best Corrected Visual Acuity (BCVA) at Each Visit Primary · 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.

Baseline

Group	Value	95% CI
LME636	71.1	± 14.58
Dexamethasone	77.2	± 14.69

Day 4

Group	Value	95% CI
LME636	70.5	± 13.92
Dexamethasone	77.9	± 12.94

Day 8

Group	Value	95% CI
LME636	72.1	± 13.62
Dexamethasone	76.8	± 11.50

Day 15

Group	Value	95% CI
LME636	74.1	± 10.11
Dexamethasone	77.1	± 11.82

Day 22

Group	Value	95% CI
LME636	74.5	± 10.41
Dexamethasone	78.2	± 11.31

Day 29

Group	Value	95% CI
LME636	73.8	± 11.70
Dexamethasone	79.2	± 11.23

Mean Intraocular Pressure (IOP) at Each Visit Primary · 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.

Baseline (Day 1)

Group	Value	95% CI
LME636	15.2	± 5.09
Dexamethasone	15.5	± 4.12

Day 4

Group	Value	95% CI
LME636	14.8	± 3.74
Dexamethasone	15.3	± 3.47

Day 8

Group	Value	95% CI
LME636	14.1	± 3.40
Dexamethasone	16.1	± 3.51

Day 15

Group	Value	95% CI
LME636	14.0	± 3.38
Dexamethasone	16.0	± 5.06

Day 22

Group	Value	95% CI
LME636	14.6	± 3.14
Dexamethasone	17.0	± 4.57

Day 29

Group	Value	95% CI
LME636	15.5	± 4.72
Dexamethasone	16.3	± 4.40

Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit Primary · 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.

Aqueous Flare

Group	Value	95% CI
LME636	9
Dexamethasone	1

Aqueous Inflammatory Cell Grade

Group	Value	95% CI
LME636	4
Dexamethasone	1

Keratic Precipitates

Group	Value	95% CI
LME636	4
Dexamethasone	0

Lens

Group	Value	95% CI
LME636	0
Dexamethasone	0

Limbal Injection

Group	Value	95% CI
LME636	7
Dexamethasone	0

Status of Lens

Group	Value	95% CI
LME636	0
Dexamethasone	0

Peripheral Anterior Synechia

Group	Value	95% CI
LME636	1
Dexamethasone	1

Posterior Synechiae

Group	Value	95% CI
LME636	8
Dexamethasone	1

Number of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment Visit Primary · 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.

Macula

Group	Value	95% CI
LME636	2
Dexamethasone	0

Optic Nerve

Group	Value	95% CI
LME636	1
Dexamethasone	0

Retina

Group	Value	95% CI
LME636	1
Dexamethasone	0

Vitreous

Group	Value	95% CI
LME636	4
Dexamethasone	0

Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment Secondary · 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.

Increase > 30 mmHg

Group	Value	95% CI
LME636	0
Dexamethasone	0

Increase 11-30 mmHg

Group	Value	95% CI
LME636	1
Dexamethasone	0

Increase 6-10 mmHg

Group	Value	95% CI
LME636	0
Dexamethasone	2

-5 mmHg Decrease - 5 mmHg Increase

Group	Value	95% CI
LME636	25
Dexamethasone	8

Decrease 6-10 mmHg

Group	Value	95% CI
LME636	1
Dexamethasone	0

Decrease 11-30 mmHg

Group	Value	95% CI
LME636	2
Dexamethasone	0

Decrease > 30 mmHg

Group	Value	95% CI
LME636	0
Dexamethasone	0

Mean Change From Baseline in BCVA at Each Visit Secondary · 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.

Baseline (BL)

Group	Value	95% CI
LME636	71.1	± 14.58
Dexamethasone	77.2	± 14.69

Change from BL at Day 4

Group	Value	95% CI
LME636	-0.1	± 9.74
Dexamethasone	0.7	± 5.40

Change from BL at Day 8

Group	Value	95% CI
LME636	0.0	± 12.84
Dexamethasone	-0.4	± 6.19

Change from BL at Day 15

Group	Value	95% CI
LME636	2.1	± 9.53
Dexamethasone	-0.1	± 3.73

Change from BL at Day 22

Group	Value	95% CI
LME636	2.8	± 9.10
Dexamethasone	1.0	± 5.06

Change from BL at Day 29

Group	Value	95% CI
LME636	2.1	± 10.36
Dexamethasone	2.0	± 5.37

Time-to-Response Secondary · 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.

Day 4

Group	Value	95% CI
LME636	9
Dexamethasone	7

Day 8

Group	Value	95% CI
LME636	5
Dexamethasone	2

Day 15

Group	Value	95% CI
LME636	1
Dexamethasone	0

Non-Responder

Group	Value	95% CI
LME636	10
Dexamethasone	1

Use of Rescue Treatment Secondary · 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.

Group	Value	95% CI
LME636	3
Dexamethasone	0
LME636	3
Dexamethasone	0
LME636	0
Dexamethasone	0
LME636	19
Dexamethasone	10

Mean Serum Concentration of Total LME636 at Each Visit Secondary · 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.

Day 1

Group	Value	95% CI
LME636	NA	± NA

Day 4

Group	Value	95% CI
LME636	NA	± NA

Day 8

Group	Value	95% CI
LME636	NA	± NA

Day 15

Group	Value	95% CI
LME636	NA	± NA

Day 22

Group	Value	95% CI
LME636	0.2510	± 0.31237

Day 29

Group	Value	95% CI
LME636	NA	± NA

Number of Subjects With Anti-LME636 Antibodies Present at Each Visit Secondary · 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.

Day 1

Group	Value	95% CI
LME636	5
Dexamethasone	3

Day 4

Group	Value	95% CI
LME636	5

Day 8

Group	Value	95% CI
LME636	6

Day 15

Group	Value	95% CI
LME636	11

Day 22

Group	Value	95% CI
LME636	17

Day 29

Group	Value	95% CI
LME636	18

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pretreatment

Serious: 0/45 (0%)

Deaths: 0/45

LME636

Serious: 1/29 (3%)

Deaths: 0/29

Dexamethasone

Serious: 0/10 (0%)

Deaths: 0/10

Posttreatment

Serious: 0/39 (0%)

Deaths: 0/39

Serious adverse events (1 terms)

Reaction	System	Pretreatment	LME636	Dexamethasone	Posttreatment
Multiple sclerosis	Nervous system disorders	—	—	—	—

Other adverse events (14 terms — click to expand)

Reaction	System	Pretreatment	LME636	Dexamethasone	Posttreatment
Anterior chamber cell	Eye disorders	—	—	—	—
Eye pain	Eye disorders	—	—	—	—
Anterior chamber flare	Eye disorders	—	—	—	—
Iridocyclitis	Eye disorders	—	—	—	—
Iris adhesions	Eye disorders	—	—	—	—
Photophobia	Eye disorders	—	—	—	—
Eye irritation	Eye disorders	—	—	—	—
Intraocular pressure increased	Investigations	—	—	—	—
Ciliary muscle spasm	Eye disorders	—	—	—	—
Iritis	Eye disorders	—	—	—	—
Lacrimation increased	Eye disorders	—	—	—	—
Vitreous detachment	Eye disorders	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—

Most-reported serious reactions: Multiple sclerosis.

Data from ClinicalTrials.gov NCT02482129 adverse events section.

Sponsor's own description

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).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Corticosteroid implants for chronic non-infectious uveitis.
Brady CJ, Villanti AC, Law HA, Rahimy E, et al · · 2016 · cited 31× · PMID 26866343 · DOI 10.1002/14651858.cd010469.pub2
Corticosteroid implants for chronic non-infectious uveitis.
Reddy A, Liu SH, Brady CJ, Sieving PC, et al · · 2023 · cited 5× · PMID 37642198 · DOI 10.1002/14651858.cd010469.pub4
Corticosteroid implants for chronic non-infectious uveitis.
Reddy A, Liu SH, Brady CJ, Sieving PC, et al · · 2023 · cited 5× · PMID 36645716 · DOI 10.1002/14651858.cd010469.pub3
Topical Ocular Anti-TNFα Agent Licaminlimab in the Treatment of Acute Anterior Uveitis: A Randomized Phase II Pilot Study.
Pasquali TA, Toyos MM, Abrams DB, Scales DK, et al · · 2022 · cited 1× · PMID 35704329 · DOI 10.1167/tvst.11.6.14

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02482129 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alcon Research
Last refreshed: 2 July 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02482129.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02482129

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other Alcon Research trials

Verify against primary sources