Allergic Conjunctivitis
Conditions
Brief summary
A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft ® as Measured by In-Vivo Confocal Microscopy
Interventions
DRUGLastacaft ®
DRUGTears Naturale ® (Placebo)
Sponsors
ORA, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conjunctival Inflammation at 1 Hour (+30 Minutes) Post CAC on Day 1 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Ocular Itching on Day 1 (15 Minutes Post-study Medication Instillation) | 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) | 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. |
Participant flow
Recruitment details
Subjects were recruited from one site in the US.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 25 |
| Tears Naturale® Eyes 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 | 25 |
| Tears Naturale® Eyes 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 | 25 |
| Total | 100 |
Baseline characteristics
| Characteristic | Lastacaft ® Eyes | Tears Naturale® Eyes | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Eyes | 0 Eyes | 0 Eyes |
| Age, Categorical >=65 years | 3 Eyes | 3 Eyes | 6 Eyes |
| Age, Categorical Between 18 and 65 years | 22 Eyes | 22 Eyes | 44 Eyes |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Eyes | 0 Eyes | 0 Eyes |
| Race (NIH/OMB) Asian | 0 Eyes | 0 Eyes | 0 Eyes |
| Race (NIH/OMB) Black or African American | 0 Eyes | 0 Eyes | 0 Eyes |
| Race (NIH/OMB) More than one race | 0 Eyes | 0 Eyes | 0 Eyes |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Eyes | 1 Eyes | 2 Eyes |
| Race (NIH/OMB) Unknown or Not Reported | 3 Eyes | 3 Eyes | 6 Eyes |
| Race (NIH/OMB) White | 21 Eyes | 21 Eyes | 42 Eyes |
| Region of Enrollment United States | 25 Eyes | 25 Eyes | 50 Eyes |
| Sex: Female, Male Female | 9 Eyes | 9 Eyes | 18 Eyes |
| Sex: Female, Male Male | 16 Eyes | 16 Eyes | 32 Eyes |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 3 / 25 | 3 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
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.
Time frame: 1 hour (+30 minutes) post CAC on Day 2
Population: All Randomized Participants Population - All participants who received study treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lastacaft® | Conjunctival Inflammation 1 Hour (+30 Minutes) Post CAC on Day 2 | 2.44 units on a scale | Standard Deviation 0.97 |
| Tears Naturale ® (Placebo) | Conjunctival Inflammation 1 Hour (+30 Minutes) Post CAC on Day 2 | 2.90 units on a scale | Standard Deviation 0.96 |
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.
Time frame: 1 hour (+30 minutes) post CAC on Day 1
Population: All Randomized Participants Population - All participants who received study treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lastacaft® | Conjunctival Inflammation at 1 Hour (+30 Minutes) Post CAC on Day 1 | 3.12 units on a scale | Standard Deviation 0.79 |
| Tears Naturale ® (Placebo) | Conjunctival Inflammation at 1 Hour (+30 Minutes) Post CAC on Day 1 | 3.02 units on a scale | Standard Deviation 0.8 |
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.
Time frame: 15 minutes post-study medication instillation
Population: All Randomized Participants Population - All participants who received study treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lastacaft® | Ocular Itching on Day 1 (15 Minutes Post-study Medication Instillation) | 3 minutes post-CAC | 0.72 units on a scale | Standard Deviation 0.91 |
| Lastacaft® | Ocular Itching on Day 1 (15 Minutes Post-study Medication Instillation) | 5 minutes post-CAC | 0.88 units on a scale | Standard Deviation 0.92 |
| Lastacaft® | Ocular Itching on Day 1 (15 Minutes Post-study Medication Instillation) | 7 minutes post-CAC | 0.91 units on a scale | Standard Deviation 0.93 |
| Tears Naturale ® (Placebo) | Ocular Itching on Day 1 (15 Minutes Post-study Medication Instillation) | 3 minutes post-CAC | 2.19 units on a scale | Standard Deviation 0.93 |
| Tears Naturale ® (Placebo) | Ocular Itching on Day 1 (15 Minutes Post-study Medication Instillation) | 5 minutes post-CAC | 2.41 units on a scale | Standard Deviation 0.86 |
| Tears Naturale ® (Placebo) | Ocular Itching on Day 1 (15 Minutes Post-study Medication Instillation) | 7 minutes post-CAC | 2.38 units on a scale | Standard Deviation 0.9 |
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.
Time frame: 15 minutes post-study medication instillation
Population: All Randomized Participants Population - All participants who received study treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lastacaft® | Ocular Itching on Day 2 (15 Minutes Post-study Medication Instillation) | 3 minutes post-CAC | 0.84 units on a scale | Standard Deviation 0.89 |
| Lastacaft® | Ocular Itching on Day 2 (15 Minutes Post-study Medication Instillation) | 5 minutes post-CAC | 1.16 units on a scale | Standard Deviation 0.87 |
| Lastacaft® | Ocular Itching on Day 2 (15 Minutes Post-study Medication Instillation) | 7 minutes post-CAC | 1.19 units on a scale | Standard Deviation 0.85 |
| Tears Naturale ® (Placebo) | Ocular Itching on Day 2 (15 Minutes Post-study Medication Instillation) | 3 minutes post-CAC | 2.00 units on a scale | Standard Deviation 1.02 |
| Tears Naturale ® (Placebo) | Ocular Itching on Day 2 (15 Minutes Post-study Medication Instillation) | 5 minutes post-CAC | 2.22 units on a scale | Standard Deviation 0.71 |
| Tears Naturale ® (Placebo) | Ocular Itching on Day 2 (15 Minutes Post-study Medication Instillation) | 7 minutes post-CAC | 2.22 units on a scale | Standard Deviation 0.71 |