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A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft ® as Measured by In-Vivo Confocal Microscopy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lastacaft ® | Drug |
| ||
| Tears Naturale ® (Placebo) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Twenty-five participants enrolled and completed the study. Participant flow and baseline characteristics are presented for the 25 subjects (50 participant eyes) that met all inclusion criteria, none of the exclusion criteria and were randomized to receive Lastacaft ® in one eye (25 participant eyes) and Tears Naturale ® (25 participant eyes) in the other based on the randomization list.
Subjects were recruited from one site in the US.
| ID | Title | Description |
|---|---|---|
| FG000 | Lastacaft ® | One drop Lastacaft ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2. If the right eye was selected for Lastacaft ® at Day 1, the right eye also received Lastacaft ® at Day 2 as dosing did not change between days. |
| FG001 | Tears Naturale ® (Placebo) | One drop Tears Naturale® (Placebo) in right eye or left eye based on randomization list once on Day 1 and once on Day 2. If the right eye was selected for Tears Naturale® (Placebo) at Day 1, the right eye also received Tears Naturale® (Placebo) at Day 2 as dosing did not change between days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 25 participants enrolled in the study. Since each subject had 1 Lastacaft ® eye and 1 Tears Naturale® eye, the baseline analysis is based on the number of eyes in each arm.
| ID | Title | Description |
|---|---|---|
| BG000 | Lastacaft ® Eyes | One drop Lastacaft ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2. If the right eye was selected for Lastacaft ® at Day 1, the right eye also received Lastacaft ® at Day 2 as dosing did not change between days. |
| BG001 | Tears Naturale® Eyes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Units |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All Randomized Participants Population - All participants who received study treatment | Posted | Mean | Standard Deviation | units on a scale | 1 hour (+30 minutes) post CAC on Day 1 | Eyes | Eyes |
|
Adverse events were collected through study completion, an average of 5 days. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lastacaft® | Participants received one drop of Lastacaft® or Tears Naturale ® (Placebo) in right eye and one drop of Lastacaft® or Tears Naturale ® (Placebo) in left eye based on the randomization list. (participants that received Lastacaft ® in one eye received Tears Naturale® in the other eye at the same time) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| filmy sensation | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caitlin Pearson | Ora | 978-685-8900 | cpearson@oraclinical.com |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| C557708 | alcaftadine |
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| 15 minutes post-study medication instillation |
| 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 |
One drop Tears Naturale® (Placebo) in right eye or left eye based on randomization list once on Day 1 and once on Day 2. If the right eye was selected for Tears Naturale® (Placebo) at Day 1, the right eye also received Tears Naturale® (Placebo) at Day 2 as dosing did not change between days |
| BG002 | Total | Total of all reporting groups |
| Eyes |
|
| Eyes |
| Eyes |
|
| Sex: Female, Male | Count of Units | Eyes | Eyes |
|
| Race (NIH/OMB) | Count of Units | Eyes | Eyes |
|
| Region of Enrollment | Number | Eyes | Eyes |
|
| OG001 | Tears Naturale ® (Placebo) | Participants received one drop of Lastacaft® or Tears Naturale ® (Placebo) in right eye and one drop of the other treatment in the left eye once on Day 1 based on the randomization list. (participants that received Tears Naturale ® in one eye received Lastacaft® in the other eye at the same time). If the right eye was selected for Lastacaft ® at Day 1, the right eye also received Lastacaft ® at Day 2 as dosing did not change between days. |
|
|
| 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. | All Randomized Participants Population - All participants who received study treatment | Posted | Mean | Standard Deviation | units on a scale | 1 hour (+30 minutes) post CAC on Day 2 | Eyes | Eyes |
|
|
|
| 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. | All Randomized Participants Population - All participants who received study treatment | Posted | Mean | Standard Deviation | units on a scale | 15 minutes post-study medication instillation | Eyes | Eyes |
|
|
|
| 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. | All Randomized Participants Population - All participants who received study treatment | Posted | Mean | Standard Deviation | units on a scale | 15 minutes post-study medication instillation | Eyes | Eyes |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 3 |
| 25 |
| EG001 | Tears Naturale ® (Placebo) | Participants received one drop of Lastacaft® or Tears Naturale ® (Placebo) in right eye and one drop of Lastacaft® or Tears Naturale ® (Placebo) in left eye based on the randomization list. (participants that received Tears Naturale ® in one eye received Lastacaft ® in the other eye at the same time) | 0 | 25 | 0 | 25 | 3 | 25 |
| blurred vision | Eye disorders | Systematic Assessment |
|
| decreased visual acuity | Eye disorders | Systematic Assessment |
|
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| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |
| 7 minutes post-CAC |
|
| 7 minutes post-CAC |
|