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

Allergic Conjunctivitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02308501
• Other study ID #: 14-100-0012
• Status: Completed
• Phase: Phase 4
• Start date: December 2014
• Est. completion date: February 2015

Study information

• Verified date: November 2020
• Source: ORA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Lastacaft ®

• Tears Naturale ® (Placebo)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ORA, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Ocular Itching on Day 1 (15 Minutes Post-study Medication Instillation)	CAC was performed 15 minutes after study medication instillation. Ocular Itching was assessed by the patient on a 0-4 scale (0 = best [no itching] to 4 = worst [severe itching]). The ocular itching score was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye ocular itching score, and the ocular itching score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye ocular itching score.	15 minutes post-study medication instillation
Secondary	Ocular Itching on Day 2 (15 Minutes Post-study Medication Instillation)	CAC was performed 15 minutes after study medication instillation. Ocular Itching was assessed by the patient on a 0-4 scale (0 = best [no itching] to 4 = worst [severe itching]). The ocular itching score was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye ocular itching score, and the ocular itching score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye ocular itching score.	15 minutes post-study medication instillation