Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge
Efficacy of Loteprednol Etabonate Ophthalmic Base Compared to Loteprednol Etabonate Ophthalmic Suspension vs Placebo in a Modified Conjunctival Allergen Challenge(CAC) Model
1 other identifier
interventional
101
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy of loteprednol etabonate ophthalmic base, compared to loteprednol etabonate ophthalmic suspension, and vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in a modified Conjunctival Allergen Challenge model and in an environmental model during pollen season. Comparisons will be made following 2 weeks of dosing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 15, 2010
CompletedFirst Posted
Study publicly available on registry
April 21, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedResults Posted
Study results publicly available
March 21, 2012
CompletedMarch 21, 2012
February 1, 2012
1 month
April 15, 2010
September 21, 2011
February 14, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
Ocular Itching
Evaluated by subject at 3, 5, and 7 min post challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.
Visit 4 (8 hr re-challenge)
Conjunctival Redness
Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.
Visit 4 (8 hr re-challenge)
Secondary Outcomes (4)
Ocular Itching
Visit 3 (initial challenge)
Conjunctival Redness
Visit 3 (initial challenge)
Ocular Itching
Visit 4 (initial challenge)
Conjunctival Redness
Visit 4 (initial challenge)
Study Arms (5)
Loteprednol etabonate base (QD)
ACTIVE COMPARATORLoteprednol etabonate ophthalmic base dosed once/day.
Loteprednol etabonate base (BID)
ACTIVE COMPARATORLoteprednol etabonate ophthalmic base dosed two times/day
Loteprednol etabonate base (QID)
ACTIVE COMPARATORLoteprednol etabonate ophthalmic base dosed four times/day.
Loteprednol etabonate suspension (QID)
ACTIVE COMPARATORLoteprednol etabonate ophthalmic suspension dosed four times/day
Vehicle of loteprednol etabonate
PLACEBO COMPARATORVehicle of loteprednol etabonate, dosed either QD, BID, or QID
Interventions
Loteprednol Etabonate ophthalmic base once daily dosing for 2 weeks
Loteprednol etabonate ophthalmic base BID dosing for 2 weeks
Loteprednol Etabonate ophthalmic base four times/day dosing for 2 week
Loteprednol etabonate ophthalmic suspension dosed four times daily for 2 weeks.
Vehicle of loteprednol etabonate ophthalmic dosed once, twice or four times daily for 2 weeks.
Eligibility Criteria
You may qualify if:
- Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
- Calculated best-corrected visual acuity of 0.70 logMAR or better in each eye as measured using the ETDRS chart.
- Positive bilateral conjunctival allergen challenge(CAC)reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
- Positive bilateral CAC reaction in 1 out of 3 time points for the initial and re-challenge at visit 2.
You may not qualify if:
- Known contraindications or sensitivities to the study medication or its components.
- Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
- Use of disallowed medications during the period indicated prior to study enrollment or during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bausch & Lomb
Rochester, New York, 14603, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tuyen Ong, MD MRCOphth
- Organization
- Bausch & Lomb Incorporated
Study Officials
- STUDY DIRECTOR
Tuyen Ong, MD
Bausch & Lomb Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2010
First Posted
April 21, 2010
Study Start
April 1, 2010
Primary Completion
May 1, 2010
Study Completion
August 1, 2010
Last Updated
March 21, 2012
Results First Posted
March 21, 2012
Record last verified: 2012-02