Allergic Conjunctivitis
Conditions
Keywords
Allergic conjunctivitis
Brief summary
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.
Detailed description
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: 1. Prednisolone Acetate 1% ophthalmic suspension 2. Prednisolone Acetate 0.12% ophthalmic suspension 3. Loteprednol Etabonate 0.2% ophthalmic suspension 4. Tears Naturale® II Duration: Approximately four (4) weeks Controls: Artificial Tears (Tears Naturale® II)
Interventions
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.
DRUGPrednisolone Acetate 0.12%
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.
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.
DRUGPlacebo
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.
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
* 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 at Baseline (Day 0) | 3, 5, 7 minutes post-CAC | 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. |
| Ocular Itching at Day 6 | 3, 5, 7 minutes post-CAC | 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. |
| Ocular Itching at Day 7 | 3, 5, 7 minutes post-CAC | 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. |
| Ocular Itching at Day 27 | 3, 5, 7 minutes post-CAC | 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. |
| Ocular Itching at Day 28 | 3, 5, 7 minutes post-CAC | 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. |
| Ocular Redness at Baseline (Day 0) | 7, 15, 20 minutes post-CAC | 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. |
| Ocular Redness at Day 6 | 7, 15, 20 minutes post-CAC | 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. |
| Ocular Redness at Day 7 | 7, 15, 20 minutes post-CAC | 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. |
| Ocular Redness at Day 27 | 7, 15, 20 minutes post-CAC | 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. |
| Ocular Redness at Day 28 | 7, 15, 20 minutes post-CAC | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from one site in the US.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| 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. | 9 |
| 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. | 9 |
| 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. | 9 |
| Total | 36 |
Baseline characteristics
| Characteristic | Pred Forte | Pred Mild | Alrex | Tears Naturale (Placebo) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 40.11 years STANDARD_DEVIATION 6.15 | 44.11 years STANDARD_DEVIATION 11.53 | 44.67 years STANDARD_DEVIATION 18.65 | 45.78 years STANDARD_DEVIATION 14.71 | 43.67 years STANDARD_DEVIATION 13.14 |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 5 Participants | 3 Participants | 16 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 4 Participants | 6 Participants | 20 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 / 9 | 0 / 9 | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 3 / 9 | 4 / 9 | 0 / 9 | 2 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 |
Outcome results
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.
Time frame: 3, 5, 7 minutes post-CAC
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pred Forte | Ocular Itching at Baseline (Day 0) | 3 minutes post-CAC | 2.53 units on a scale | Standard Deviation 0.507 |
| Pred Forte | Ocular Itching at Baseline (Day 0) | 7 minutes post-CAC | 3.03 units on a scale | Standard Deviation 0.734 |
| Pred Forte | Ocular Itching at Baseline (Day 0) | 5 minutes post-CAC | 2.92 units on a scale | Standard Deviation 0.661 |
| Pred Mild | Ocular Itching at Baseline (Day 0) | 3 minutes post-CAC | 3.08 units on a scale | Standard Deviation 0.771 |
| Pred Mild | Ocular Itching at Baseline (Day 0) | 7 minutes post-CAC | 3.44 units on a scale | Standard Deviation 0.447 |
| Pred Mild | Ocular Itching at Baseline (Day 0) | 5 minutes post-CAC | 3.47 units on a scale | Standard Deviation 0.475 |
| Alrex | Ocular Itching at Baseline (Day 0) | 5 minutes post-CAC | 3.06 units on a scale | Standard Deviation 0.682 |
| Alrex | Ocular Itching at Baseline (Day 0) | 3 minutes post-CAC | 2.61 units on a scale | Standard Deviation 0.953 |
| Alrex | Ocular Itching at Baseline (Day 0) | 7 minutes post-CAC | 3.08 units on a scale | Standard Deviation 0.685 |
| Tears Naturale | Ocular Itching at Baseline (Day 0) | 3 minutes post-CAC | 2.5 units on a scale | Standard Deviation 0.781 |
| Tears Naturale | Ocular Itching at Baseline (Day 0) | 7 minutes post-CAC | 2.83 units on a scale | Standard Deviation 0.612 |
| Tears Naturale | Ocular Itching at Baseline (Day 0) | 5 minutes post-CAC | 2.75 units on a scale | Standard Deviation 0.612 |
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.
Time frame: 3, 5, 7 minutes post-CAC
Population: Per Protocol Population (PP)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pred Forte | Ocular Itching at Day 27 | 3 minutes post-CAC | 2.14 units on a scale | Standard Deviation 1.119 |
| Pred Forte | Ocular Itching at Day 27 | 7 minutes post-CAC | 2.03 units on a scale | Standard Deviation 1.314 |
| Pred Forte | Ocular Itching at Day 27 | 5 minutes post-CAC | 2.17 units on a scale | Standard Deviation 1.281 |
| Pred Mild | Ocular Itching at Day 27 | 3 minutes post-CAC | 2.43 units on a scale | Standard Deviation 1.231 |
| Pred Mild | Ocular Itching at Day 27 | 7 minutes post-CAC | 2.64 units on a scale | Standard Deviation 1.189 |
| Pred Mild | Ocular Itching at Day 27 | 5 minutes post-CAC | 2.64 units on a scale | Standard Deviation 1.189 |
| Alrex | Ocular Itching at Day 27 | 5 minutes post-CAC | 2.09 units on a scale | Standard Deviation 1.239 |
| Alrex | Ocular Itching at Day 27 | 3 minutes post-CAC | 1.75 units on a scale | Standard Deviation 1.433 |
| Alrex | Ocular Itching at Day 27 | 7 minutes post-CAC | 2 units on a scale | Standard Deviation 1.382 |
| Tears Naturale | Ocular Itching at Day 27 | 3 minutes post-CAC | 2.03 units on a scale | Standard Deviation 0.871 |
| Tears Naturale | Ocular Itching at Day 27 | 7 minutes post-CAC | 1.72 units on a scale | Standard Deviation 0.807 |
| Tears Naturale | Ocular Itching at Day 27 | 5 minutes post-CAC | 1.84 units on a scale | Standard Deviation 0.801 |
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.
Time frame: 3, 5, 7 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pred Forte | Ocular Itching at Day 28 | 3 minutes post-CAC | 1.83 units on a scale | Standard Deviation 1.111 |
| Pred Forte | Ocular Itching at Day 28 | 7 minutes post-CAC | 1.89 units on a scale | Standard Deviation 1.426 |
| Pred Forte | Ocular Itching at Day 28 | 5 minutes post-CAC | 1.97 units on a scale | Standard Deviation 1.343 |
| Pred Mild | Ocular Itching at Day 28 | 3 minutes post-CAC | 2.25 units on a scale | Standard Deviation 1.267 |
| Pred Mild | Ocular Itching at Day 28 | 7 minutes post-CAC | 2.71 units on a scale | Standard Deviation 1.228 |
| Pred Mild | Ocular Itching at Day 28 | 5 minutes post-CAC | 2.64 units on a scale | Standard Deviation 1.24 |
| Alrex | Ocular Itching at Day 28 | 5 minutes post-CAC | 2 units on a scale | Standard Deviation 1.482 |
| Alrex | Ocular Itching at Day 28 | 3 minutes post-CAC | 2.03 units on a scale | Standard Deviation 1.404 |
| Alrex | Ocular Itching at Day 28 | 7 minutes post-CAC | 1.78 units on a scale | Standard Deviation 1.417 |
| Tears Naturale | Ocular Itching at Day 28 | 3 minutes post-CAC | 1.75 units on a scale | Standard Deviation 0.835 |
| Tears Naturale | Ocular Itching at Day 28 | 7 minutes post-CAC | 1.56 units on a scale | Standard Deviation 0.853 |
| Tears Naturale | Ocular Itching at Day 28 | 5 minutes post-CAC | 1.78 units on a scale | Standard Deviation 0.901 |
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.
Time frame: 3, 5, 7 minutes post-CAC
Population: Per Protocol Population (PP)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pred Forte | Ocular Itching at Day 6 | 3 minutes post-CAC | 2.17 units on a scale | Standard Deviation 0.781 |
| Pred Forte | Ocular Itching at Day 6 | 7 minutes post-CAC | 2.17 units on a scale | Standard Deviation 0.968 |
| Pred Forte | Ocular Itching at Day 6 | 5 minutes post-CAC | 2.44 units on a scale | Standard Deviation 0.778 |
| Pred Mild | Ocular Itching at Day 6 | 3 minutes post-CAC | 2.19 units on a scale | Standard Deviation 1.108 |
| Pred Mild | Ocular Itching at Day 6 | 7 minutes post-CAC | 2.72 units on a scale | Standard Deviation 0.891 |
| Pred Mild | Ocular Itching at Day 6 | 5 minutes post-CAC | 2.59 units on a scale | Standard Deviation 0.954 |
| Alrex | Ocular Itching at Day 6 | 5 minutes post-CAC | 2.41 units on a scale | Standard Deviation 0.963 |
| Alrex | Ocular Itching at Day 6 | 3 minutes post-CAC | 2.06 units on a scale | Standard Deviation 0.904 |
| Alrex | Ocular Itching at Day 6 | 7 minutes post-CAC | 2.31 units on a scale | Standard Deviation 1.007 |
| Tears Naturale | Ocular Itching at Day 6 | 3 minutes post-CAC | 2.33 units on a scale | Standard Deviation 0.76 |
| Tears Naturale | Ocular Itching at Day 6 | 7 minutes post-CAC | 2.14 units on a scale | Standard Deviation 0.674 |
| Tears Naturale | Ocular Itching at Day 6 | 5 minutes post-CAC | 2.53 units on a scale | Standard Deviation 0.824 |
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.
Time frame: 3, 5, 7 minutes post-CAC
Population: Per Protocol Population (PP)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pred Forte | Ocular Itching at Day 7 | 3 minutes post-CAC | 2.11 units on a scale | Standard Deviation 0.858 |
| Pred Forte | Ocular Itching at Day 7 | 5 minutes post-CAC | 2.11 units on a scale | Standard Deviation 0.894 |
| Pred Forte | Ocular Itching at Day 7 | 7 minutes post-CAC | 1.97 units on a scale | Standard Deviation 0.956 |
| Pred Mild | Ocular Itching at Day 7 | 5 minutes post-CAC | 2.69 units on a scale | Standard Deviation 1.007 |
| Pred Mild | Ocular Itching at Day 7 | 3 minutes post-CAC | 2.28 units on a scale | Standard Deviation 1.004 |
| Pred Mild | Ocular Itching at Day 7 | 7 minutes post-CAC | 2.75 units on a scale | Standard Deviation 0.896 |
| Alrex | Ocular Itching at Day 7 | 5 minutes post-CAC | 2.03 units on a scale | Standard Deviation 0.85 |
| Alrex | Ocular Itching at Day 7 | 7 minutes post-CAC | 1.88 units on a scale | Standard Deviation 0.982 |
| Alrex | Ocular Itching at Day 7 | 3 minutes post-CAC | 2.09 units on a scale | Standard Deviation 1.069 |
| Tears Naturale | Ocular Itching at Day 7 | 7 minutes post-CAC | 1.72 units on a scale | Standard Deviation 0.93 |
| Tears Naturale | Ocular Itching at Day 7 | 3 minutes post-CAC | 2.03 units on a scale | Standard Deviation 1.064 |
| Tears Naturale | Ocular Itching at Day 7 | 5 minutes post-CAC | 1.94 units on a scale | Standard Deviation 1.108 |
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pred Forte | Ocular Redness at Baseline (Day 0) | 15 minutes post-CAC | 2.33 units on a scale | Standard Deviation 0.573 |
| Pred Forte | Ocular Redness at Baseline (Day 0) | 7 minutes post-CAC | 2.11 units on a scale | Standard Deviation 0.651 |
| Pred Forte | Ocular Redness at Baseline (Day 0) | 20 minutes post-CAC | 2.22 units on a scale | Standard Deviation 0.537 |
| Pred Mild | Ocular Redness at Baseline (Day 0) | 15 minutes post-CAC | 2.31 units on a scale | Standard Deviation 0.349 |
| Pred Mild | Ocular Redness at Baseline (Day 0) | 7 minutes post-CAC | 2.11 units on a scale | Standard Deviation 0.532 |
| Pred Mild | Ocular Redness at Baseline (Day 0) | 20 minutes post-CAC | 2.28 units on a scale | Standard Deviation 0.384 |
| Alrex | Ocular Redness at Baseline (Day 0) | 15 minutes post-CAC | 2.11 units on a scale | Standard Deviation 0.182 |
| Alrex | Ocular Redness at Baseline (Day 0) | 7 minutes post-CAC | 1.86 units on a scale | Standard Deviation 0.333 |
| Alrex | Ocular Redness at Baseline (Day 0) | 20 minutes post-CAC | 2 units on a scale | Standard Deviation 0.125 |
| Tears Naturale | Ocular Redness at Baseline (Day 0) | 15 minutes post-CAC | 2.25 units on a scale | Standard Deviation 0.415 |
| Tears Naturale | Ocular Redness at Baseline (Day 0) | 20 minutes post-CAC | 2.06 units on a scale | Standard Deviation 0.41 |
| Tears Naturale | Ocular Redness at Baseline (Day 0) | 7 minutes post-CAC | 2.08 units on a scale | Standard Deviation 0.354 |
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pred Forte | Ocular Redness at Day 27 | 20 minutes post-CAC | 1.53 units on a scale | Standard Deviation 0.814 |
| Pred Forte | Ocular Redness at Day 27 | 7 minutes post-CAC | 1.72 units on a scale | Standard Deviation 0.701 |
| Pred Forte | Ocular Redness at Day 27 | 15 minutes post-CAC | 1.72 units on a scale | Standard Deviation 0.723 |
| Pred Mild | Ocular Redness at Day 27 | 7 minutes post-CAC | 2.14 units on a scale | Standard Deviation 0.349 |
| Pred Mild | Ocular Redness at Day 27 | 20 minutes post-CAC | 1.89 units on a scale | Standard Deviation 0.575 |
| Pred Mild | Ocular Redness at Day 27 | 15 minutes post-CAC | 2.11 units on a scale | Standard Deviation 0.476 |
| Alrex | Ocular Redness at Day 27 | 15 minutes post-CAC | 1.63 units on a scale | Standard Deviation 0.567 |
| Alrex | Ocular Redness at Day 27 | 7 minutes post-CAC | 1.44 units on a scale | Standard Deviation 0.32 |
| Alrex | Ocular Redness at Day 27 | 20 minutes post-CAC | 1.53 units on a scale | Standard Deviation 0.558 |
| Tears Naturale | Ocular Redness at Day 27 | 7 minutes post-CAC | 1.56 units on a scale | Standard Deviation 0.776 |
| Tears Naturale | Ocular Redness at Day 27 | 20 minutes post-CAC | 1.72 units on a scale | Standard Deviation 0.749 |
| Tears Naturale | Ocular Redness at Day 27 | 15 minutes post-CAC | 1.72 units on a scale | Standard Deviation 0.674 |
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pred Forte | Ocular Redness at Day 28 | 20 minutes post-CAC | 1.5 units on a scale | Standard Deviation 0.791 |
| Pred Forte | Ocular Redness at Day 28 | 7 minutes post-CAC | 1.58 units on a scale | Standard Deviation 0.82 |
| Pred Forte | Ocular Redness at Day 28 | 15 minutes post-CAC | 1.81 units on a scale | Standard Deviation 0.827 |
| Pred Mild | Ocular Redness at Day 28 | 15 minutes post-CAC | 2.11 units on a scale | Standard Deviation 0.378 |
| Pred Mild | Ocular Redness at Day 28 | 7 minutes post-CAC | 1.96 units on a scale | Standard Deviation 0.393 |
| Pred Mild | Ocular Redness at Day 28 | 20 minutes post-CAC | 1.86 units on a scale | Standard Deviation 0.476 |
| Alrex | Ocular Redness at Day 28 | 15 minutes post-CAC | 1.69 units on a scale | Standard Deviation 0.753 |
| Alrex | Ocular Redness at Day 28 | 7 minutes post-CAC | 1.69 units on a scale | Standard Deviation 0.637 |
| Alrex | Ocular Redness at Day 28 | 20 minutes post-CAC | 1.69 units on a scale | Standard Deviation 0.717 |
| Tears Naturale | Ocular Redness at Day 28 | 7 minutes post-CAC | 1.81 units on a scale | Standard Deviation 0.788 |
| Tears Naturale | Ocular Redness at Day 28 | 20 minutes post-CAC | 1.72 units on a scale | Standard Deviation 0.761 |
| Tears Naturale | Ocular Redness at Day 28 | 15 minutes post-CAC | 1.94 units on a scale | Standard Deviation 0.863 |
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Per Protocol Population (PP)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pred Forte | Ocular Redness at Day 6 | 7 minutes post-CAC | 2 units on a scale | Standard Deviation 0.515 |
| Pred Forte | Ocular Redness at Day 6 | 20 minutes post-CAC | 2 units on a scale | Standard Deviation 0.866 |
| Pred Forte | Ocular Redness at Day 6 | 15 minutes post-CAC | 1.97 units on a scale | Standard Deviation 0.775 |
| Pred Mild | Ocular Redness at Day 6 | 20 minutes post-CAC | 2.31 units on a scale | Standard Deviation 0.691 |
| Pred Mild | Ocular Redness at Day 6 | 7 minutes post-CAC | 2.22 units on a scale | Standard Deviation 0.508 |
| Pred Mild | Ocular Redness at Day 6 | 15 minutes post-CAC | 2.41 units on a scale | Standard Deviation 0.626 |
| Alrex | Ocular Redness at Day 6 | 20 minutes post-CAC | 2.03 units on a scale | Standard Deviation 0.452 |
| Alrex | Ocular Redness at Day 6 | 15 minutes post-CAC | 2.13 units on a scale | Standard Deviation 0.327 |
| Alrex | Ocular Redness at Day 6 | 7 minutes post-CAC | 1.84 units on a scale | Standard Deviation 0.823 |
| Tears Naturale | Ocular Redness at Day 6 | 7 minutes post-CAC | 2.11 units on a scale | Standard Deviation 0.858 |
| Tears Naturale | Ocular Redness at Day 6 | 20 minutes post-CAC | 2.17 units on a scale | Standard Deviation 0.992 |
| Tears Naturale | Ocular Redness at Day 6 | 15 minutes post-CAC | 2.28 units on a scale | Standard Deviation 0.996 |
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Per Protocol Population (PP)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pred Forte | Ocular Redness at Day 7 | 7 minutes post-CAC | 2.08 units on a scale | Standard Deviation 0.451 |
| Pred Forte | Ocular Redness at Day 7 | 20 minutes post-CAC | 1.72 units on a scale | Standard Deviation 0.765 |
| Pred Forte | Ocular Redness at Day 7 | 15 minutes post-CAC | 1.83 units on a scale | Standard Deviation 0.791 |
| Pred Mild | Ocular Redness at Day 7 | 7 minutes post-CAC | 1.53 units on a scale | Standard Deviation 0.761 |
| Pred Mild | Ocular Redness at Day 7 | 20 minutes post-CAC | 1.78 units on a scale | Standard Deviation 0.986 |
| Pred Mild | Ocular Redness at Day 7 | 15 minutes post-CAC | 1.69 units on a scale | Standard Deviation 0.894 |
| Alrex | Ocular Redness at Day 7 | 15 minutes post-CAC | 1.59 units on a scale | Standard Deviation 0.706 |
| Alrex | Ocular Redness at Day 7 | 7 minutes post-CAC | 1.59 units on a scale | Standard Deviation 0.706 |
| Alrex | Ocular Redness at Day 7 | 20 minutes post-CAC | 1.47 units on a scale | Standard Deviation 0.737 |
| Tears Naturale | Ocular Redness at Day 7 | 7 minutes post-CAC | 1.59 units on a scale | Standard Deviation 0.778 |
| Tears Naturale | Ocular Redness at Day 7 | 20 minutes post-CAC | 1.5 units on a scale | Standard Deviation 0.973 |
| Tears Naturale | Ocular Redness at Day 7 | 15 minutes post-CAC | 1.66 units on a scale | Standard Deviation 0.981 |