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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:
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.
Duration:
Approximately 19 days
Controls:
Artificial Tears (Tears Naturale® II)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisolone | Experimental | Prednisolone Sodium Phosphate Ophthalmic Solution, 1% |
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| Placebo | Placebo Comparator | Tears Naturale II Ophthalmic Solution, 1% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone Sodium Phosphate Ophthalmic Solution 1% | Drug | One drop in each eye, four times/day for 8 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 5 minutes post-CAC |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 7 Minutes post-CAC |
| Episcleral Redness Change From Baseline to Day 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tarek Shazly, MD | Ophthalmic society of Egypt, Egyptian Glaucoma Society, American Acadamy of Ophthalmology, American Glaucoma Society, The association for research in vision and ophthalmology, international society of refractive surgery, Pan Arab Glaucoma Society | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prednisolone | Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye four times/day (QID) for 8 days. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Tears Naturale II Ophthalmic Solution | Drug | one drop in each eye, four times/ day (QID) for 8 days |
|
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). |
| 7 minutes post-CAC |
| 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). | 7 minutes post-CAC |
Tears Naturale II Ophthalmic Solution, 1%
Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Prednisolone | Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye QID for 8 days. |
| BG001 | Placebo | Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days |
| BG002 | Total | Total of all reporting groups |
| 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 Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | 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). | All participants who completed the study | Posted | Mean | Standard Deviation | units on a scale | 5 minutes post-CAC |
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| 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) | All participants who completed the study | Posted | Mean | Standard Deviation | score on a scale | 7 Minutes post-CAC |
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| 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). | All participants who completed the study | Posted | Mean | Standard Deviation | score on a scale | 7 minutes post-CAC |
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| 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). | All participants who completed the study | Posted | Mean | Standard Deviation | score on a scale | 7 minutes post-CAC |
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AEs were collected from the date of informed consent to the date of the final visit (1 month).
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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 | Prednisolone | Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 8 days. | 0 | 5 | 0 | 5 | 1 | 5 |
| EG001 | Placebo | Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 8 days | 0 | 6 | 0 | 6 | 3 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mucous Discharge (OU) | Eye disorders | Systematic Assessment |
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| Headache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Backache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith Lane | Ora | 9786896500 | klane@oraclinical.com |
| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| >=65 years |
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| Male |
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