Phase 2
N=43
Proof of Concept Study to Evaluate Safety and Efficacy of LME636 in the Treatment of Acute Anterior Uveitis
Acute Anterior Uveitis
Bottom Line
View on ClinicalTrials.gov: NCT02482129 ↗Enrolled (actual)
43
Serious AEs
0.8%
Results posted
Aug 2017
Primary outcome: Primary: Number of Responders at Day 15 — 14; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LME636 60 mg/mL ophthalmic solution (Drug); Dexamethasone 0.1% ophthalmic solution (Drug); LME636 Vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Responders at Day 15 |
14; 9 | — |
| PRIMARY Mean Best Corrected Visual Acuity (BCVA) at Each Visit |
71.1; 77.2; 70.5; 77.9; 72.1; 76.8 | — |
| PRIMARY Mean Intraocular Pressure (IOP) at Each Visit |
15.2; 15.5; 14.8; 15.3; 14.1; 16.1 | — |
| PRIMARY Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit |
9; 1; 4; 1; 4; 0 | — |
| PRIMARY Number of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment Visit |
2; 0; 1; 0; 1; 0 | — |
| SECONDARY Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment |
0; 0; 1; 0; 0; 2 | — |
| SECONDARY Mean Change From Baseline in BCVA at Each Visit |
71.1; 77.2; -0.1; 0.7; 0.0; -0.4 | — |
| SECONDARY Time-to-Response |
9; 7; 5; 2; 1; 0 | — |
| SECONDARY Use of Rescue Treatment |
3; 0; 3; 0; 0; 0 | — |
| SECONDARY Mean Serum Concentration of Total LME636 at Each Visit |
NA; NA; NA; NA; 0.2510; NA | — |
| SECONDARY Number of Subjects With Anti-LME636 Antibodies Present at Each Visit |
5; 3; 5; 6; 11; 17 | — |
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).
Eligibility Criteria
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 exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02482129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.