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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02308501
Other study ID # 14-100-0012
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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