Back to resultsA Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Lastacaft ®
Tears Naturale ® (Placebo)
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Lastacaft ®
Tears Naturale ®
Arm Description
One drop Lastacaft ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2
One drop Tears Naturale ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02308501
Brief Title
A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ORA, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft ® as Measured by In-Vivo Confocal Microscopy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lastacaft ®
Arm Type
Active Comparator
Arm Description
One drop Lastacaft ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2
Arm Title
Tears Naturale ®
Arm Type
Placebo Comparator
Arm Description
One drop Tears Naturale ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2
Intervention Type
Drug
Intervention Name(s)
Lastacaft ®
Intervention Type
Drug
Intervention Name(s)
Tears Naturale ® (Placebo)
Primary Outcome Measure Information:
Title
Conjunctival Inflammation at 1 Hour (+30 Minutes) Post CAC on Day 1
Description
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.
Time Frame
1 hour (+30 minutes) post CAC on Day 1
Title
Conjunctival Inflammation 1 Hour (+30 Minutes) Post CAC on Day 2
Description
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.
Time Frame
1 hour (+30 minutes) post CAC on Day 2
Secondary Outcome Measure Information:
Title
Ocular Itching on Day 1 (15 Minutes Post-study Medication Instillation)
Description
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.
Time Frame
15 minutes post-study medication instillation
Title
Ocular Itching on Day 2 (15 Minutes Post-study Medication Instillation)
Description
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.
Time Frame
15 minutes post-study medication instillation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy
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