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To evaluate the efficacy of prednisolone acetate 1% ophthalmic suspension as compared to prednisolone acetate 0.12% ophthalmic suspension, loteprednol etabonate 0.2% ophthalmic suspension, and placebo (Tears Naturale® II) in the prevention of the signs and symptoms of allergic conjunctivitis. Comparisons will be made following 1 week of twice daily (BID) dosing and 1 week of four times daily (QID) dosing.
Structure:
Prospective, single center, randomized, double-masked, parallel treatment comparison study. Subjects will be randomized to one of the following treatment arms to be dosed bilaterally twice daily (BID) for the first dosing period and four times daily (QID) for the second dosing period:
Duration:
Approximately four (4) weeks
Controls:
Artificial Tears (Tears Naturale® II)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pred acetate 1% | Active Comparator | Prednisolone acetate 1.0% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. |
|
| Pred acetate .12% | Active Comparator | Prednisolone acetate 0.12% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. |
|
| Lot Etab 0.2% | Active Comparator | Loteprednol Etabonate 0.2% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. |
|
| Placebo | Placebo Comparator | Tears Naturale (Artificial Tears) in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone Acetate 1% | Drug | One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching at Baseline (Day 0) | A baseline CAC was performed on Day 0. Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. | 3, 5, 7 minutes post-CAC |
| Ocular Itching at Day 6 | Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. | 3, 5, 7 minutes post-CAC |
| Ocular Itching at Day 7 | Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 7. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. | 3, 5, 7 minutes post-CAC |
| Ocular Itching at Day 27 | Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 27. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. | 3, 5, 7 minutes post-CAC |
| Ocular Itching at Day 28 | Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. | 3, 5, 7 minutes post-CAC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail L Torkildsen, MD | American board of Ophthalmology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Research Associates | Andover | Massachusetts | 01810 | United States |
Participant flow and baseline characteristics are presented for the 36 subjects that met all inclusion and none of the exclusion criteria and were randomized to receive Pred Forte, Pred Mild, Alrex, or Tears Naturale. 36 subjects were enrolled, 4 discontinued, and 32 subjects completed the study.
Subjects were recruited from one site in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pred Forte | 1 drop in each eye up to 4 times daily for up to 4 weeks |
| FG001 | Pred Mild | 1 drop in each eye up to 4 times daily for up to 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Prednisolone Acetate 0.12% | Drug | One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. |
|
|
| Loteprednol Etabonate 0.2% | Drug | One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. |
|
|
| Placebo | Drug | One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. |
|
|
| Ocular Redness at Baseline (Day 0) |
A baseline CAC was performed on Day 0. Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. |
| 7, 15, 20 minutes post-CAC |
| Ocular Redness at Day 6 | Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC |
| Ocular Redness at Day 7 | Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 7. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC |
| Ocular Redness at Day 27 | Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 27. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC |
| Ocular Redness at Day 28 | Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC |
| FG002 | Alrex | 1 drop in each eye up to 4 times daily for up to 4 weeks |
| FG003 | Tears Naturale | 1 drop in each eye up to 4 times daily for up to 4 weeks |
| Intent to Treat |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pred Forte | Prednisolone acetate 1.0% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. |
| BG001 | Pred Mild | Prednisolone acetate 0.12% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. |
| BG002 | Alrex | Loteprednol Etabonate 0.2% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. |
| BG003 | Tears Naturale (Placebo) | Tears Naturale (Artificial Tears) in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. |
| BG004 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 at Baseline (Day 0) | A baseline CAC was performed on Day 0. Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. | Full Analysis Set | Posted | Mean | Standard Deviation | units on a scale | 3, 5, 7 minutes post-CAC |
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| Primary | Ocular Itching at Day 6 | Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. | Per Protocol Population (PP) | Posted | Mean | Standard Deviation | units on a scale | 3, 5, 7 minutes post-CAC |
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| Primary | Ocular Itching at Day 7 | Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 7. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. | Per Protocol Population (PP) | Posted | Mean | Standard Deviation | units on a scale | 3, 5, 7 minutes post-CAC |
| ||||||||||||||||||||||||||||||||||||
| Primary | Ocular Itching at Day 27 | Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 27. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. | Per Protocol Population (PP) | Posted | Mean | Standard Deviation | units on a scale | 3, 5, 7 minutes post-CAC |
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| Primary | Ocular Itching at Day 28 | Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 3, 5, 7 minutes post-CAC |
| ||||||||||||||||||||||||||||||||||||
| Primary | Ocular Redness at Baseline (Day 0) | A baseline CAC was performed on Day 0. Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. | Full Analysis Set | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
| ||||||||||||||||||||||||||||||||||||
| Primary | Ocular Redness at Day 6 | Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. | Per Protocol Population (PP) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
| ||||||||||||||||||||||||||||||||||||
| Primary | Ocular Redness at Day 7 | Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 7. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. | Per Protocol Population (PP) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Primary | Ocular Redness at Day 27 | Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 27. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
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| Primary | Ocular Redness at Day 28 | Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 7, 15, 20 minutes post-CAC |
|
Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
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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 | Pred Forte | 1 drop in each eye up to 4 times daily during a 4 week period | 0 | 9 | 0 | 9 | 3 | 9 |
| EG001 | Pred Mild | 1 drop in each eye up to 4 times daily during a 4 week period | 0 | 9 | 0 | 9 | 4 | 9 |
| EG002 | Alrex | 1 drop in each eye up to 4 times daily during a 4 week period | 0 | 9 | 0 | 9 | 0 | 9 |
| EG003 | Tears Naturale | 1 drop in each eye up to 4 times daily during a 4 week period | 0 | 9 | 0 | 9 | 2 | 9 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stinging upon instillation of dose 1 QD (Morning dose every day) | Eye disorders | Systematic Assessment |
| ||
| Increase in IOP (5 unit) | Eye disorders | Systematic Assessment |
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| Taste Perversion | General disorders | Systematic Assessment |
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| Burning upon instillation | Eye disorders | Systematic Assessment |
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| Lower lid swelling | Eye disorders | Systematic Assessment |
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| Itching secondary to Posion Ivy | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Worsening of Rhinitis 1 hour after instillation of Dose 1 | General disorders | Systematic Assessment |
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| Worsening of Headache | General disorders | Systematic Assessment |
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| Ocular fatigue sensation | Eye disorders | Systematic Assessment |
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| Taste perversion upon instillation | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Gomes | ORA | 9786858900 | pgomes@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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| ID | Term |
|---|---|
| C009935 | prednisolone acetate |
| D008775 | Methylprednisolone |
| D000069559 | Loteprednol Etabonate |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |
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| Male |
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| 5 minutes post-CAC |
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| 7 minutes post-CAC |
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