Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge

Allergic Conjunctivitis Clinical Trial

Official title:

Efficacy of Loteprednol Etabonate Ophthalmic Base Compared to Loteprednol Etabonate Ophthalmic Suspension vs Placebo in a Modified Conjunctival Allergen Challenge(CAC) Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107405
• Other study ID #: 584
• Status: Completed
• Phase: Phase 2
• First received: April 15, 2010
• Last updated: February 14, 2012
• Start date: April 2010
• Est. completion date: August 2010

Study information

• Verified date: February 2012
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: August 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Loteprednol etabonate base (QD)
Loteprednol Etabonate ophthalmic base once daily dosing for 2 weeks
• Loteprednol etabonate base (BID)
Loteprednol etabonate ophthalmic base BID dosing for 2 weeks
• Loteprednol etabonate base (QID)
Loteprednol Etabonate ophthalmic base four times/day dosing for 2 week
• Loteprednol etabonate suspension
Loteprednol etabonate ophthalmic suspension dosed four times daily for 2 weeks.
• Vehicle of loteprednol etabonate
Vehicle of loteprednol etabonate ophthalmic dosed once, twice or four times daily for 2 weeks.

Locations

Country	Name	City	State
United States	Bausch & Lomb	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	Ocular Itching	Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.	Visit 3 (initial challenge)	No
Secondary	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 3 (initial challenge)	No
Secondary	Ocular Itching	Evaluated by the 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 (initial challenge)	No
Secondary	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 (initial challenge)	No