Seasonal Allergic Conjunctivitis
Conditions
Keywords
ocular allergy
Brief summary
This study is to evaluate the safety and efficacy of Alrex (LE ophthalmic suspension, 0.2%) versus Patanol (olopatadine hydrochloride ophthalmic solution, 0.1%) in the temporary relief of the signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).
Interventions
1 drop of Alrex 4 times daily (QID) in both eyes at approximately 4 hour intervals for 2 weeks.
DRUGOlopatadine 0.1%
1 drop of Patanol 2 times daily (BID)at intervals of 6-8 hours or more for 2 weeks.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who are diagnosed with acute SAC and experience at least grade 4 ocular itching and at least grade 2 bulbar conjunctival injection (redness) in each eye due to seasonal allergy at Visit 1.
Exclusion criteria
* Subjects who have a known hypersensitivity to the study medications or their components or contraindications to ocular corticosteroids. * Subjects who use any of the disallowed medications throughout the duration of the study and during the period indicated prior to Visit 1. * Subjects who have intraocular pressure (IOP) greater than 21 mm Hg in either eye or any type of glaucoma. * Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study or affect the subject's safety or trial parameters.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bulbar Conjunctival Injection | Change from baseline to day 15 (visit 3) | Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe |
| Ocular Itching | Change from baseline to day 15 (visit 3) | Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bulbar Conjunctival Injection | Change from baseline to day 8 (visit 2) | Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe |
| Ocular Itching | Change from baseline to day 8 (visit 2) | Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe |
Countries
Singapore
Participant flow
Recruitment details
Three hundred participants were enrolled in the study. First participant was enrolled 08/03/2010, last participant exited on 04/26/2011. This study was conducted at 7 sites in China.
Pre-assignment details
Three hundred participants were randomized into two groups, 151 to be treated with Alrex and 149 to be treated with Patanol.
Participants by arm
| Arm | Count |
|---|---|
| Alrex Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2% | 151 |
| Patanol Ophthalmic solution containing olopatadine, 0.1% | 149 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Did not meet eligibility criteria | 2 | 0 |
| Overall Study | Lost to Follow-up | 6 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Alrex | Patanol | Total |
|---|---|---|---|
| Age Continuous | 40.5 years STANDARD_DEVIATION 14.01 | 40.6 years STANDARD_DEVIATION 12.85 | 40.6 years STANDARD_DEVIATION 13.43 |
| Race/Ethnicity, Customized Chinese | 151 participants | 149 participants | 300 participants |
| Sex: Female, Male Female | 99 Participants | 103 Participants | 202 Participants |
| Sex: Female, Male Male | 52 Participants | 46 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 151 | 0 / 149 |
| serious Total, serious adverse events | 1 / 151 | 0 / 149 |
Outcome results
Primary
Bulbar Conjunctival Injection
Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe
Time frame: Change from baseline to day 15 (visit 3)
Population: Participants analyzed from the per protocol (PP) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alrex | Bulbar Conjunctival Injection | -1.91 units on a scale | Standard Deviation 0.521 |
| Patanol | Bulbar Conjunctival Injection | -1.71 units on a scale | Standard Deviation 0.585 |
Primary
Ocular Itching
Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe
Time frame: Change from baseline to day 15 (visit 3)
Population: Participants analyzed from the per protocol (PP) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alrex | Ocular Itching | -3.74 units on a scale | Standard Deviation 0.469 |
| Patanol | Ocular Itching | -3.28 units on a scale | Standard Deviation 0.908 |
Secondary
Bulbar Conjunctival Injection
Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe
Time frame: Change from baseline to day 8 (visit 2)
Population: Participants analyzed from the per protocol (PP) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alrex | Bulbar Conjunctival Injection | -1.36 units on a scale | Standard Deviation 0.569 |
| Patanol | Bulbar Conjunctival Injection | -1.18 units on a scale | Standard Deviation 0.61 |
Secondary
Ocular Itching
Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe
Time frame: Change from baseline to day 8 (visit 2)
Population: Participants analyzed from the per protocol (PP) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alrex | Ocular Itching | -2.46 units on a scale | Standard Deviation 0.876 |
| Patanol | Ocular Itching | -2.02 units on a scale | Standard Deviation 0.851 |