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: * 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 8 days between Visits 4 and 5. * Prednisolone phosphate * Tears Naturale II Ophthalmic Solution (Placebo) Duration: Approximately 19 days Controls: Artificial Tears (Tears Naturale® II)
Interventions
One drop in each eye, four times/day for 8 days.
one drop in each eye, four times/ day (QID) for 8 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 |
|---|---|---|
| Ocular Itching Change From Baseline to Day 11 | 5 minutes post-CAC | Ocular itching, as assessed by the participant, was measured on a 4-point scale 5 minutes after the conjunctival allergen challenge (CAC). 0 was best (no itching), and 4 was worst (worst itching). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conjunctival Redness Change From Baseline to Day 11 | 7 Minutes post-CAC | Conjunctival Redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (no redness), and 4 was worst (most redness) |
| Episcleral Redness Change From Baseline to Day 6 | 7 minutes post-CAC | Episcleral redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC.0 was best (least redness), and 4 was worst (most redness). |
| Ciliary Redness Change From Baseline to Day 6 | 7 minutes post-CAC | Ciliary redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (least redness), and 4 was 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 QID for 8 days. | 4 |
| Placebo Tears Naturale II Ophthalmic Solution, 1%
Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days | 5 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | Prednisolone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 4 Participants | 8 Participants |
| Age, Continuous | 49.5 years STANDARD_DEVIATION 13.329 | 49.6 years STANDARD_DEVIATION 6.693 | 49.55 years STANDARD_DEVIATION 8.896 |
| Region of Enrollment United States | 5 participants | 4 participants | 9 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 6 |
| other Total, other adverse events | 1 / 5 | 3 / 6 |
| serious Total, serious adverse events | 0 / 5 | 0 / 6 |
Outcome results
Primary
Ocular Itching Change From Baseline to Day 11
Ocular itching, as assessed by the participant, was measured on a 4-point scale 5 minutes after the conjunctival allergen challenge (CAC). 0 was best (no itching), and 4 was worst (worst itching).
Time frame: 5 minutes post-CAC
Population: All participants who completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prednisolone | Ocular Itching Change From Baseline to Day 11 | -1.1 units on a scale | Standard Deviation 0.14 |
| Placebo | Ocular Itching Change From Baseline to Day 11 | -0.45 units on a scale | Standard Deviation 0.86 |
Secondary
Ciliary Redness Change From Baseline to Day 6
Ciliary redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (least redness), and 4 was worst (most redness).
Time frame: 7 minutes post-CAC
Population: All participants who completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prednisolone | Ciliary Redness Change From Baseline to Day 6 | -0.94 score on a scale | Standard Deviation 0.66 |
| Placebo | Ciliary Redness Change From Baseline to Day 6 | 0.30 score on a scale | Standard Deviation 0.96 |
Secondary
Conjunctival Redness Change From Baseline to Day 11
Conjunctival Redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (no redness), and 4 was worst (most redness)
Time frame: 7 Minutes post-CAC
Population: All participants who completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prednisolone | Conjunctival Redness Change From Baseline to Day 11 | -0.69 score on a scale | Standard Deviation 0.31 |
| Placebo | Conjunctival Redness Change From Baseline to Day 11 | 0.40 score on a scale | Standard Deviation 0.88 |
Secondary
Episcleral Redness Change From Baseline to Day 6
Episcleral redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC.0 was best (least redness), and 4 was worst (most redness).
Time frame: 7 minutes post-CAC
Population: All participants who completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prednisolone | Episcleral Redness Change From Baseline to Day 6 | -1.0 score on a scale | Standard Deviation 0.41 |
| Placebo | Episcleral Redness Change From Baseline to Day 6 | 0.45 score on a scale | Standard Deviation 0.93 |