A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy

Ora, Inc.

Status and phase: Completed; Phase 4

Conditions: Allergic Conjunctivitis

Treatments: Drug: Tears Naturale ® (Placebo); Drug: Lastacaft ®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02308501

14-100-0012

Details and patient eligibility

About

A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft ® as Measured by In-Vivo Confocal Microscopy

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a positive history of ocular allergies and a positive skin test to protocol defined allergens
• Have a positive CAC reaction at Visit 1
• Have a positive conjunctival inflammation score at Visit 1

Exclusion criteria

• May not use disallowed medications in specified washout period
• May not have an ocular or system disease the investigator feels with impact subject safety or trial parameters
• May not have active ocular infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

25 participants in 2 patient groups, including a placebo group

Lastacaft ®

Active Comparator group

Description:

One drop Lastacaft ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2

Treatment:

Drug: Lastacaft ®

Tears Naturale ®

Placebo Comparator group

Description:

One drop Tears Naturale ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2

Treatment:

Drug: Tears Naturale ® (Placebo)