Chronic Allergic Conjunctivitis
Conditions
Brief summary
The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication, Prednisolone, assessed by the following measures: Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival redness
Detailed description
Prospective, single center, randomized, double-masked, placebo controlled study. Subjects will be randomized to one of the following treatment arms to dose four times per day (QID) for 4 days between Visits 3 and 4. Prednisolone phosphate Tears Naturale II Ophthalmic Solution (Placebo) Duration: Approximately 2 weeks Controls: Artificial Tears (Tears Naturale® II)
Interventions
One drop in each eye, four times/day for 4 days.
one drop in each eye, four times/ day (QID) for 4 days
Sponsors
ORA, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age & either sex, any race * Willing and able to follow all instructions * Positive history of ocular allergies * Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge
Exclusion criteria
* Have planned surgery during trial period * Female currently pregnant, planning a pregnancy or lactating * Use of disallowed medications * Have ocular infections, or ocular conditions that could affect study parameters * Have moderate to severe dry eye * Have used an investigational drug or device within 30 days of start of study * Female that is currently pregnant, planning a pregnancy or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation Change From Baseline to Day 6 | 90 minutes post CAC | Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Itching Change From Baseline to Day 6 | 7 minutes post-CAC | Ocular itching was measured by subject on a scale of 0 to 4 where 0 = no itching and 4 = worst itching. This measurement was taken 7 minutes post CAC |
| Ocular Redness Change From Baseline to Day 6 | 7 minutes post-CAC | Ocular redness was measured by the investigator on a 4-point scale 7 minutes post-CAC. 0 = best (no redness), 4 = worst (most redness). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prednisolone Prednisolone Sodium Phosphate Ophthalmic Solution, 1%
Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days. | 8 |
| Placebo Tears Naturale II Ophthalmic Solution, 1%
Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days | 5 |
| Saline A group of three allergic subjects will be challenged with saline only to evaluate the impact of confocal microscopy on ocular signs and symptoms in the absence of allergic challenge. These five subjects will receive placebo in an open label fashion and will not require randomization. | 3 |
| Total | 16 |
Baseline characteristics
| Characteristic | Prednisolone | Placebo | Saline | Total |
|---|---|---|---|---|
| Age, Continuous | 41.75 years STANDARD_DEVIATION 1.461897 | 37.2 years STANDARD_DEVIATION 1.830301 | 39.33 years STANDARD_DEVIATION 0.905539 | 39.88 years STANDARD_DEVIATION 0.0707107 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 6 Participants | 4 Participants | 3 Participants | 13 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 2 Participants | 7 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 1 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 5 | 0 / 3 |
| other Total, other adverse events | 2 / 8 | 1 / 5 | 0 / 3 |
| serious Total, serious adverse events | 0 / 8 | 0 / 5 | 0 / 3 |
Outcome results
Primary
Inflammation Change From Baseline to Day 6
Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation).
Time frame: 90 minutes post CAC
Population: The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prednisolone | Inflammation Change From Baseline to Day 6 | -1.2 score on a scale | Standard Deviation 0.78 |
| Placebo | Inflammation Change From Baseline to Day 6 | -0.19 score on a scale | Standard Deviation 0.43 |
Secondary
Ocular Itching Change From Baseline to Day 6
Ocular itching was measured by subject on a scale of 0 to 4 where 0 = no itching and 4 = worst itching. This measurement was taken 7 minutes post CAC
Time frame: 7 minutes post-CAC
Population: The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prednisolone | Ocular Itching Change From Baseline to Day 6 | -1.1 score on a scale | Standard Deviation 1.3 |
| Placebo | Ocular Itching Change From Baseline to Day 6 | -1.0 score on a scale | Standard Deviation 1.29 |
Secondary
Ocular Redness Change From Baseline to Day 6
Ocular redness was measured by the investigator on a 4-point scale 7 minutes post-CAC. 0 = best (no redness), 4 = worst (most redness).
Time frame: 7 minutes post-CAC
Population: The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prednisolone | Ocular Redness Change From Baseline to Day 6 | -1.1 score on a scale | Standard Deviation 1.38 |
| Placebo | Ocular Redness Change From Baseline to Day 6 | 0.31 score on a scale | Standard Deviation 1.01 |