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

NCT02308501 | Completed Phase 4 Results

• 1 other identifier: 14-100-0012
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (2)

• Conjunctival Inflammation at 1 Hour (+30 Minutes) Post CAC on Day 1

  Conjunctival Inflammation was assessed by a trained technician post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0 = best \[least inflammation\] and 4 = worst \[most inflammation\]). The Conjunctival Inflammation was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye Conjunctival Inflammation score, and the Conjunctival Inflammation score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye Conjunctival Inflammation score.

  1 hour (+30 minutes) post CAC on Day 1

• Conjunctival Inflammation 1 Hour (+30 Minutes) Post CAC on Day 2

  Conjunctival Inflammation was assessed by a trained technician post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0 = best \[least inflammation\] and 4 = worst \[most inflammation\]). The Conjunctival Inflammation was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye Conjunctival Inflammation score, and the Conjunctival Inflammation score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye Conjunctival Inflammation score.

  1 hour (+30 minutes) post CAC on Day 2

Secondary Outcomes (2)

• Ocular Itching on Day 1 (15 Minutes Post-study Medication Instillation)

  15 minutes post-study medication instillation

• Ocular Itching on Day 2 (15 Minutes Post-study Medication Instillation)

  15 minutes post-study medication instillation

Study Arms (2)

Lastacaft ®

ACTIVE COMPARATOR

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

Drug: Lastacaft ®

Tears Naturale ®

PLACEBO COMPARATOR

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

Drug: Tears Naturale ® (Placebo)

Interventions

Lastacaft ® DRUG

Lastacaft ®

Tears Naturale ® (Placebo) DRUG

Tears Naturale ®

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ORA, Inc.: lead

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

alcaftadine

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Caitlin Pearson
• Organization: Ora

cpearson@oraclinical.com

978-685-8900

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 4, 2014
• Study Start: December 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 18, 2021
• Results First Posted: March 18, 2021

Record last verified: 2020-11