Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01435460
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 33.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Seasonal Allergic Conjunctivitis	Drug: Loteprednol etabonate 0.2%; Drug: Olopatadine 0.1%	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: A Clinical Safety and Efficacy Evaluation of Alrex® (Loteprednol Etabonate Ophthalmic Suspension, 0.2%) Versus Patanol (Olopatadine Hydrochloride Ophthalmic Solution, 0.1%) in the Treatment of Seasonal Allergic Conjunctivitis (SAC)
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alrex Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%	Drug: Loteprednol etabonate 0.2%; 1 drop of Alrex 4 times daily (QID) in both eyes at approximately 4 hour intervals for 2 weeks.; Other Names: Alrex
Active Comparator: Patanol Ophthalmic solution containing olopatadine, 0.1%	Drug: Olopatadine 0.1%; 1 drop of Patanol 2 times daily (BID)at intervals of 6-8 hours or more for 2 weeks.; Other Names: Patanol

Outcome Measures

Primary Outcome Measures

1. 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

2. 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 Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bausch & Lomb Singapore	Singapore		Singapore	556741

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Esther Chu, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01435460
• Other Study ID Numbers: 634
• First Posted: Sep 16, 2011
• Last Update Posted: Mar 13, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by Bausch & Lomb Incorporated: ocular allergy
• Additional relevant MeSH terms: Conjunctivitis; Conjunctivitis, Allergic; Loteprednol Etabonate; Olopatadine Hydrochloride

Study Results

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 Detail	Three hundred participants were randomized into two groups, 151 to be treated with Alrex and 149 to be treated with Patanol.

Arm/Group Title	Alrex	Patanol
Arm/Group Description	Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%	Ophthalmic solution containing olopatadine, 0.1%
Period Title: Overall Study
STARTED	151	149
COMPLETED	140	143
NOT COMPLETED	11	6

Baseline Characteristics

Arm/Group Title	Alrex	Patanol	Total
Arm/Group Description	Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%	Ophthalmic solution containing olopatadine, 0.1%	Total of all reporting groups
Overall Participants	151	149	300
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.5 (14.01)	40.6 (12.85)	40.6 (13.43)
Sex: Female, Male (Count of Participants)
Female	99 65.6%	103 69.1%	202 67.3%
Male	52 34.4%	46 30.9%	98 32.7%
Race/Ethnicity, Customized (participants) [Number]
Chinese	151 100%	149 100%	300 100%

Outcome Measures

1. Primary Outcome

Title	Bulbar Conjunctival Injection
Description	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)

Outcome Measure Data

Analysis Population Description

Participants analyzed from the per protocol (PP) population

Arm/Group Title	Alrex	Patanol
Arm/Group Description	Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%	Ophthalmic solution containing olopatadine, 0.1%
Measure Participants	138	142
Mean (Standard Deviation) [units on a scale]	-1.91 (0.521)	-1.71 (0.585)

2. Primary Outcome

Title	Ocular Itching
Description	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)

Outcome Measure Data

Analysis Population Description

Participants analyzed from the per protocol (PP) population

Arm/Group Title	Alrex	Patanol
Arm/Group Description	Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%	Ophthalmic solution containing olopatadine, 0.1%
Measure Participants	138	142
Mean (Standard Deviation) [units on a scale]	-3.74 (0.469)	-3.28 (0.908)

3. Secondary Outcome

Title	Bulbar Conjunctival Injection
Description	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)

Outcome Measure Data

Analysis Population Description

Participants analyzed from the per protocol (PP) population

Arm/Group Title	Alrex	Patanol
Arm/Group Description	Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%	Ophthalmic solution containing olopatadine, 0.1%
Measure Participants	140	141
Mean (Standard Deviation) [units on a scale]	-1.36 (0.569)	-1.18 (0.610)

4. Secondary Outcome

Title	Ocular Itching
Description	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)

Outcome Measure Data

Analysis Population Description

Participants analyzed from the per protocol (PP) population

Arm/Group Title	Alrex	Patanol
Arm/Group Description	Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%	Ophthalmic solution containing olopatadine, 0.1%
Measure Participants	140	141
Mean (Standard Deviation) [units on a scale]	-2.46 (0.876)	-2.02 (0.851)

Adverse Events

Time Frame	15 days
Arm/Group Title	Alrex		Patanol
Arm/Group Description	Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%		Ophthalmic solution containing olopatadine, 0.1%
All Cause Mortality
	Alrex		Patanol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Alrex		Patanol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/151 (0.7%)		0/149 (0%)
Respiratory, thoracic and mediastinal disorders
Deviated Septum	1/151 (0.7%)	1	0/149 (0%)	0
Other (Not Including Serious) Adverse Events
	Alrex		Patanol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/151 (0%)		0/149 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.