A Dose-Escalation Study to Assess the Safety and Tolerability of LX214 Ophthalmic Solution in Healthy Volunteers, Followed by an Open-Label Evaluation of LX214 in Patients With Keratoconjunctivitis Sicca (KCS)

Lux Biosciences

Status and phase: Completed; Phase 1

Conditions: Keratoconjunctivitis Sicca

Treatments: Drug: voclosporin ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00851734

LX214-01

Details and patient eligibility

About

This is a first-in-man study for the purpose of determining the safety and tolerability of LX214 ophthalmic solution in healthy volunteers and in patients with dry eye syndrome.

Enrollment: 35 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• No systemic disease as determined by a physical examination, clinical laboratory evaluation, and an ECG
• Schirmer's I Test ≥ 10mm/5 minutes with anesthesia
• Corrected Snellen acuity of 20/40 or better in both eyes

Exclusion criteria

• Subjects diagnosed with any ocular disease other than refraction error
• Subjects with intraocular pressure >21 mmHg
• Use of a contact lens within 7 days prior to administration of the first dose
• Subjects with history of ocular surgery
• Subjects with a history of laser refractive surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 3 patient groups, including a placebo group

LX214 0.02%

Experimental group

Description:

LX214 ophthalmic solution 0.02%

Treatment:

Drug: voclosporin ophthalmic solution

LX214 0.2%

Experimental group

Treatment:

Drug: voclosporin ophthalmic solution

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: voclosporin ophthalmic solution