Trial Outcomes & Findings for Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC) (NCT NCT01435460)
NCT ID: NCT01435460
Last Updated: 2012-03-13
Results Overview
Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe
COMPLETED
PHASE3
300 participants
Change from baseline to day 15 (visit 3)
2012-03-13
Participant Flow
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.
Three hundred participants were randomized into two groups, 151 to be treated with Alrex and 149 to be treated with Patanol.
Participant milestones
| Measure |
Alrex
Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
|
Patanol
Ophthalmic solution containing olopatadine, 0.1%
|
|---|---|---|
|
Overall Study
STARTED
|
151
|
149
|
|
Overall Study
COMPLETED
|
140
|
143
|
|
Overall Study
NOT COMPLETED
|
11
|
6
|
Reasons for withdrawal
| Measure |
Alrex
Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
|
Patanol
Ophthalmic solution containing olopatadine, 0.1%
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Did not meet eligibility criteria
|
2
|
0
|
Baseline Characteristics
Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)
Baseline characteristics by cohort
| Measure |
Alrex
n=151 Participants
Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
|
Patanol
n=149 Participants
Ophthalmic solution containing olopatadine, 0.1%
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
40.5 years
STANDARD_DEVIATION 14.01 • n=5 Participants
|
40.6 years
STANDARD_DEVIATION 12.85 • n=7 Participants
|
40.6 years
STANDARD_DEVIATION 13.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
151 participants
n=5 Participants
|
149 participants
n=7 Participants
|
300 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to day 15 (visit 3)Population: Participants analyzed from the per protocol (PP) population
Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe
Outcome measures
| Measure |
Alrex
n=138 Participants
Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
|
Patanol
n=142 Participants
Ophthalmic solution containing olopatadine, 0.1%
|
|---|---|---|
|
Bulbar Conjunctival Injection
|
-1.91 units on a scale
Standard Deviation 0.521
|
-1.71 units on a scale
Standard Deviation 0.585
|
PRIMARY outcome
Timeframe: Change from baseline to day 15 (visit 3)Population: Participants analyzed from the per protocol (PP) population
Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe
Outcome measures
| Measure |
Alrex
n=138 Participants
Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
|
Patanol
n=142 Participants
Ophthalmic solution containing olopatadine, 0.1%
|
|---|---|---|
|
Ocular Itching
|
-3.74 units on a scale
Standard Deviation 0.469
|
-3.28 units on a scale
Standard Deviation 0.908
|
SECONDARY outcome
Timeframe: Change from baseline to day 8 (visit 2)Population: Participants analyzed from the per protocol (PP) population
Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe
Outcome measures
| Measure |
Alrex
n=140 Participants
Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
|
Patanol
n=141 Participants
Ophthalmic solution containing olopatadine, 0.1%
|
|---|---|---|
|
Bulbar Conjunctival Injection
|
-1.36 units on a scale
Standard Deviation 0.569
|
-1.18 units on a scale
Standard Deviation 0.610
|
SECONDARY outcome
Timeframe: Change from baseline to day 8 (visit 2)Population: Participants analyzed from the per protocol (PP) population
Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe
Outcome measures
| Measure |
Alrex
n=140 Participants
Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
|
Patanol
n=141 Participants
Ophthalmic solution containing olopatadine, 0.1%
|
|---|---|---|
|
Ocular Itching
|
-2.46 units on a scale
Standard Deviation 0.876
|
-2.02 units on a scale
Standard Deviation 0.851
|
Adverse Events
Alrex
Patanol
Serious adverse events
| Measure |
Alrex
n=151 participants at risk
Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
|
Patanol
n=149 participants at risk
Ophthalmic solution containing olopatadine, 0.1%
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Deviated Septum
|
0.66%
1/151 • Number of events 1 • 15 days
|
0.00%
0/149 • 15 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s)after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
- Publication restrictions are in place
Restriction type: OTHER