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

NCT02482129 | Completed Phase 2 Results

• 1 other identifier: LME636-2201
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Acute Anterior Uveitis

Keywords

Acute anterior uveitis; LME636

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline (Day 1), Day 15

• Mean Best Corrected Visual Acuity (BCVA) at Each Visit

  Visual Acuity (VA) with the subject's best spectacles or other visual corrective devices was measured using an Early Treatment of Diabetic Retinopathy Study (ETDRS) or Snellen visual acuity chart and reported in letters read correctly. An increase (gain) in letters read indicates improvement. Only one eye contributed to the analysis.

  Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29

• Mean Intraocular Pressure (IOP) at Each Visit

  IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry or Tonopen and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.

  Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29

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

  Slit-lamp biomicroscopy (examination) was performed to evaluate the anterior segment of the eye, including lids/lashes, conjunctiva, cornea, anterior chamber (cells and flare), iris, and lens. Ocular signs were categorized as Aqueous Flare, Aqueous Inflammatory Cell Grade, Keratic Precipitates, Lens, Limbal Injection, Status of Lens, Peripheral Anterior Synechia, and Posterior Synechia. An increase indicates worsening. Only one eye contributed to the analysis.

  Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29

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

  The dilated fundus examination was performed to evaluate the health of the vitreous, optic disc, retinal vessels, macula, and retinal periphery. An increase indicates worsening. Only one eye contributed to the analysis.

  Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29

Secondary Outcomes (6)

• Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment

  Baseline (Day 1), Up to Day 29

• Mean Change From Baseline in BCVA at Each Visit

  Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29

• Time-to-Response

  Baseline (Day 1), Up to Day 15

• Use of Rescue Treatment

  Day 4, Day 8, Day 15

• Mean Serum Concentration of Total LME636 at Each Visit

  Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29

Study Arms (2)

LME636

EXPERIMENTAL

LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)

Drug: LME636 60 mg/mL ophthalmic solution; Drug: LME636 Vehicle

Dexamethasone

ACTIVE COMPARATOR

Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)

Drug: Dexamethasone 0.1% ophthalmic solution

Interventions

LME636 60 mg/mL ophthalmic solution DRUG

LME636

Dexamethasone 0.1% ophthalmic solution DRUG

Dexamethasone

LME636 Vehicle DRUG

Inactive ingredients used for masking purposes

LME636

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Uveitis, Anterior

Interventions

Ophthalmic Solutions; Dexamethasone

Condition Hierarchy (Ancestors)

Panuveitis; Uveitis; Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Ophthalmology & Medical Lead, Translational Medicine, NIBR
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Scientist NIBR, Alcon

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: June 26, 2015
• Study Start: July 17, 2015
• Primary Completion: March 21, 2016
• Study Completion: March 21, 2016
• Last Updated: July 2, 2018
• Results First Posted: August 28, 2017

Record last verified: 2017-07