Allergic Conjunctivitis
Conditions
Brief summary
To evaluate the efficacy and safety of two concentrations of PRT-2761 as a topical ophthalmic solution for the treatment of the signs and symptoms of acute and chronic allergic conjunctivitis.
Interventions
DRUGPRT-2761 0.5%
Six drops in each eye over a 17 day period.
DRUGPRT-2761 1%
Six drops in each eye over a 17 day period.
DRUGPatanol
Six drops in each eye over a 17 day period.
DRUGPred-forte
Four drops in each eye over a 3 day period.
DRUGPRT-2761 0%
Six drops in each eye over a 17 day period.
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
* be at least 18 years old * be willing and able to avoid all disallowed medications and contact lenses * must have a pregnancy test if of childbearing potential * must be able to read an eye chart from 10 feet away
Exclusion criteria
* must not have any allergies to the study medications * must not have any ocular or non ocular condition that investigator feels will interfere with study parameters * must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1 | post CAC exposure at 5, 7, and 10 minutes post CAC on Day 1 | Ocular Itching was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no itching) to 4=severe (worst/most itching). The ocular itching was averaged across all subjects at each time point. |
| Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15 | post CAC exposure at 5, 7, and 10 minutes post CAC on Day 15 | Ocular Itching was assessed by the subjects using a 0 to 4 point scale(0=none (best/no itching) to 4=severe (worst/most itching)). The ocular itching was averaged across all subjects at each time point. |
| Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1 | post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 1. | Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)). The conjunctival redness was averaged across all subjects at each time point. |
| Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15 | post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 15. | Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)). The conjunctival redness was averaged across all subjects at each time point. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from one site in the US.
Pre-assignment details
One hundred and twenty participants enrolled and 97 subjects completed the study. Participant flow and baseline characteristics are presented for 120 subjects that met all inclusion, none of the exclusion criteria, and were randomized to receive one of five treatments based on the randomization list.
Participants by arm
| Arm | Count |
|---|---|
| PRT-2761 0.5% PRT-2761 0.5%: Six drops in each eye over a 17 day period. | 32 |
| PRT-2761 1% PRT-2761 1%: Six drops in each eye over a 17 day period. | 29 |
| Patanol Patanol: Six drops in each eye over a 17 day period. | 30 |
| PRT-2761 0% PRT-2761 0%: Six drops in each eye over a 17 day period. | 29 |
| Total | 120 |
Baseline characteristics
| Characteristic | PRT-2761 0.5% | PRT-2761 1% | Patanol | PRT-2761 0% | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 27 Participants | 30 Participants | 27 Participants | 114 Participants |
| Age, Continuous | 52 years STANDARD_DEVIATION 14.49 | 49 years STANDARD_DEVIATION 12.98 | 46 years STANDARD_DEVIATION 10.81 | 52 years STANDARD_DEVIATION 9.21 | 50 years STANDARD_DEVIATION 12.98 |
| Allergen Type Perennial | 10 Participants | 8 Participants | 10 Participants | 9 Participants | 37 Participants |
| Allergen Type Seasonal | 22 Participants | 21 Participants | 20 Participants | 20 Participants | 83 Participants |
| Average Post-CAC Itching Score at Baseline ≤ 2.5 | 7 Participants | 5 Participants | 6 Participants | 5 Participants | 23 Participants |
| Average Post-CAC Itching Score at Baseline > 2.5 | 25 Participants | 24 Participants | 24 Participants | 24 Participants | 97 Participants |
| Confocal Participation No | 21 Participants | 21 Participants | 20 Participants | 21 Participants | 83 Participants |
| Confocal Participation Yes | 11 Participants | 8 Participants | 10 Participants | 8 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 9 Participants | 3 Participants | 5 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 20 Participants | 27 Participants | 24 Participants | 100 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Iris Color Black | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Iris Color Blue | 10 Participants | 12 Participants | 8 Participants | 6 Participants | 36 Participants |
| Iris Color Brown | 13 Participants | 12 Participants | 15 Participants | 17 Participants | 57 Participants |
| Iris Color Green | 5 Participants | 1 Participants | 2 Participants | 3 Participants | 11 Participants |
| Iris Color Hazel | 4 Participants | 4 Participants | 5 Participants | 1 Participants | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 2 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 29 Participants | 27 Participants | 27 Participants | 23 Participants | 106 Participants |
| Region of Enrollment United States | 32 participants | 29 participants | 30 participants | 29 participants | 120 participants |
| Sex: Female, Male Female | 24 Participants | 12 Participants | 16 Participants | 15 Participants | 67 Participants |
| Sex: Female, Male Male | 8 Participants | 17 Participants | 14 Participants | 14 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 29 | 0 / 30 | 0 / 29 |
| other Total, other adverse events | 4 / 32 | 9 / 29 | 1 / 30 | 7 / 29 |
| serious Total, serious adverse events | 0 / 32 | 0 / 29 | 0 / 30 | 0 / 29 |
Outcome results
Primary
Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1
Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)). The conjunctival redness was averaged across all subjects at each time point.
Time frame: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 1.
Population: All Randomized Participants Population - All participants who received study treatment.~Note: Pred forte subjects receive Patanol up to and including Visit 5a and are analyzed as Patanol subjects for those visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRT-2761 0.5% | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1 | 7 minutes post-CAC | 1.282 units on a scale | Standard Deviation 0.6479 |
| PRT-2761 0.5% | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1 | 20 minutes post-CAC | 1.371 units on a scale | Standard Deviation 0.5841 |
| PRT-2761 0.5% | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1 | 15 minutes post-CAC | 1.411 units on a scale | Standard Deviation 0.6142 |
| PRT-2761 1% | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1 | 7 minutes post-CAC | 1.491 units on a scale | Standard Deviation 0.5919 |
| PRT-2761 1% | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1 | 20 minutes post-CAC | 1.603 units on a scale | Standard Deviation 0.6251 |
| PRT-2761 1% | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1 | 15 minutes post-CAC | 1.526 units on a scale | Standard Deviation 0.5989 |
| Patanol | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1 | 15 minutes post-CAC | 1.833 units on a scale | Standard Deviation 0.735 |
| Patanol | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1 | 7 minutes post-CAC | 1.592 units on a scale | Standard Deviation 0.7236 |
| Patanol | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1 | 20 minutes post-CAC | 1.917 units on a scale | Standard Deviation 0.6833 |
| PRT-2761 0% | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1 | 7 minutes post-CAC | 1.957 units on a scale | Standard Deviation 0.4913 |
| PRT-2761 0% | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1 | 20 minutes post-CAC | 2.164 units on a scale | Standard Deviation 0.4496 |
| PRT-2761 0% | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1 | 15 minutes post-CAC | 2.181 units on a scale | Standard Deviation 0.3774 |
Primary
Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15
Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)). The conjunctival redness was averaged across all subjects at each time point.
Time frame: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 15.
Population: All Randomized Participants Population - All participants who received study treatment.~Note: Pred forte subjects receive Patanol up to and including Visit 5a.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRT-2761 0.5% | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15 | 7 minutes post-CAC | 1.723 units on a scale | Standard Deviation 0.5787 |
| PRT-2761 0.5% | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15 | 20 minutes post-CAC | 1.857 units on a scale | Standard Deviation 0.6289 |
| PRT-2761 0.5% | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15 | 15 minutes post-CAC | 1.920 units on a scale | Standard Deviation 0.6703 |
| PRT-2761 1% | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15 | 7 minutes post-CAC | 2.056 units on a scale | Standard Deviation 0.4458 |
| PRT-2761 1% | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15 | 20 minutes post-CAC | 2.222 units on a scale | Standard Deviation 0.6699 |
| PRT-2761 1% | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15 | 15 minutes post-CAC | 2.176 units on a scale | Standard Deviation 0.4894 |
| Patanol | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15 | 15 minutes post-CAC | 1.617 units on a scale | Standard Deviation 0.7478 |
| Patanol | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15 | 7 minutes post-CAC | 1.242 units on a scale | Standard Deviation 0.7296 |
| Patanol | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15 | 20 minutes post-CAC | 1.592 units on a scale | Standard Deviation 0.7266 |
| PRT-2761 0% | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15 | 7 minutes post-CAC | 1.973 units on a scale | Standard Deviation 0.4731 |
| PRT-2761 0% | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15 | 20 minutes post-CAC | 2.036 units on a scale | Standard Deviation 0.6372 |
| PRT-2761 0% | Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15 | 15 minutes post-CAC | 1.991 units on a scale | Standard Deviation 0.5464 |
Primary
Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1
Ocular Itching was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no itching) to 4=severe (worst/most itching). The ocular itching was averaged across all subjects at each time point.
Time frame: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 1
Population: All Randomized Participants Population - All participants who received study treatment.~Note: Pred forte subjects receive Patanol up to and including Visit 5a and are analyzed as Patanol subjects for those visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRT-2761 0.5% | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1 | 5 minutes post-CAC | 2.573 units on a scale | Standard Deviation 0.9246 |
| PRT-2761 0.5% | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1 | 10 minutes post-CAC | 2.250 units on a scale | Standard Deviation 1.0878 |
| PRT-2761 0.5% | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1 | 7 minutes post-CAC | 2.677 units on a scale | Standard Deviation 0.8879 |
| PRT-2761 1% | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1 | 5 minutes post-CAC | 2.500 units on a scale | Standard Deviation 0.7792 |
| PRT-2761 1% | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1 | 10 minutes post-CAC | 2.293 units on a scale | Standard Deviation 1.0135 |
| PRT-2761 1% | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1 | 7 minutes post-CAC | 2.509 units on a scale | Standard Deviation 0.8114 |
| Patanol | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1 | 7 minutes post-CAC | 1.358 units on a scale | Standard Deviation 0.8627 |
| Patanol | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1 | 5 minutes post-CAC | 1.217 units on a scale | Standard Deviation 0.8826 |
| Patanol | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1 | 10 minutes post-CAC | 1.258 units on a scale | Standard Deviation 0.9727 |
| PRT-2761 0% | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1 | 5 minutes post-CAC | 2.647 units on a scale | Standard Deviation 0.817 |
| PRT-2761 0% | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1 | 10 minutes post-CAC | 2.190 units on a scale | Standard Deviation 0.8754 |
| PRT-2761 0% | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1 | 7 minutes post-CAC | 2.629 units on a scale | Standard Deviation 0.7459 |
Primary
Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15
Ocular Itching was assessed by the subjects using a 0 to 4 point scale(0=none (best/no itching) to 4=severe (worst/most itching)). The ocular itching was averaged across all subjects at each time point.
Time frame: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 15
Population: All Randomized Participants Population - All participants who received study treatment.~Note: Pred forte subjects receive Patanol up to and including Visit 5a and are analyzed as Patanol subjects for those visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRT-2761 0.5% | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15 | 5 minutes post-CAC | 2.431 units on a scale | Standard Deviation 1.1415 |
| PRT-2761 0.5% | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15 | 10 minutes post-CAC | 1.922 units on a scale | Standard Deviation 1.1242 |
| PRT-2761 0.5% | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15 | 7 minutes post-CAC | 2.362 units on a scale | Standard Deviation 1.0724 |
| PRT-2761 1% | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15 | 5 minutes post-CAC | 2.611 units on a scale | Standard Deviation 0.7731 |
| PRT-2761 1% | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15 | 10 minutes post-CAC | 2.204 units on a scale | Standard Deviation 1.063 |
| PRT-2761 1% | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15 | 7 minutes post-CAC | 2.602 units on a scale | Standard Deviation 0.7883 |
| Patanol | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15 | 7 minutes post-CAC | 0.808 units on a scale | Standard Deviation 0.7505 |
| Patanol | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15 | 5 minutes post-CAC | 0.775 units on a scale | Standard Deviation 0.7172 |
| Patanol | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15 | 10 minutes post-CAC | 0.833 units on a scale | Standard Deviation 0.8077 |
| PRT-2761 0% | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15 | 5 minutes post-CAC | 2.527 units on a scale | Standard Deviation 0.9288 |
| PRT-2761 0% | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15 | 10 minutes post-CAC | 1.929 units on a scale | Standard Deviation 0.9425 |
| PRT-2761 0% | Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15 | 7 minutes post-CAC | 2.366 units on a scale | Standard Deviation 0.9317 |