Clinical trial NCT00689078: Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
Official title: Single Center, Randomized, Double-Masked Evaluation of the Efficacy of PredAcetate 1% Ophthalmic Suspension Compared to Pred Acetate 0.12% Ophthalmic Suspension, Lot Etab 0.2% Ophthalmic Suspension, and Placebo in a Modified CAC Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Conjunctivitis
Keywords: Allergic conjunctivitis
Lead sponsor: ORA, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of prednisolone acetate 1% ophthalmic suspension as compared to prednisolone acetate 0.12% ophthalmic suspension, loteprednol etabonate 0.2% ophthalmic suspension, and placebo (Tears Naturale® II) in the prevention of the signs and symptoms of allergic conjunctivitis. Comparisons will be made following 1 week of twice daily (BID) dosing and 1 week of four times daily (QID) dosing.

Detailed description: Structure:

Prospective, single center, randomized, double-masked, parallel treatment comparison study. Subjects will be randomized to one of the following treatment arms to be dosed bilaterally twice daily (BID) for the first dosing period and four times daily (QID) for the second dosing period:

1. Prednisolone Acetate 1% ophthalmic suspension
2. Prednisolone Acetate 0.12% ophthalmic suspension
3. Loteprednol Etabonate 0.2% ophthalmic suspension
4. Tears Naturale® II

Duration:

Approximately four (4) weeks

Controls:

Artificial Tears (Tears Naturale® II)

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age \& either sex, any race
* Willing and able to follow all instructions
* Positive history of ocular allergies
* Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge

Exclusion Criteria:

* Have planned surgery during trial period
* Female currently pregnant, planning a pregnancy or lactating
* Use of disallowed medications
* Have ocular infections, or ocular conditions that could affect study parameters
* Have moderate to severe dry eye
* Have used an investigational drug or device within 30 days of start of study
* Female that is currently pregnant, planning a pregnancy or lactating

Primary outcomes:
measure: Ocular Itching at Baseline (Day 0)
timeFrame: 3, 5, 7 minutes post-CAC
measure: Ocular Itching at Day 6
timeFrame: 3, 5, 7 minutes post-CAC
measure: Ocular Itching at Day 7
timeFrame: 3, 5, 7 minutes post-CAC
measure: Ocular Itching at Day 27
timeFrame: 3, 5, 7 minutes post-CAC
measure: Ocular Itching at Day 28
timeFrame: 3, 5, 7 minutes post-CAC
measure: Ocular Redness at Baseline (Day 0)
timeFrame: 7, 15, 20 minutes post-CAC
measure: Ocular Redness at Day 6
timeFrame: 7, 15, 20 minutes post-CAC
measure: Ocular Redness at Day 7
timeFrame: 7, 15, 20 minutes post-CAC
measure: Ocular Redness at Day 27
timeFrame: 7, 15, 20 minutes post-CAC
measure: Ocular Redness at Day 28
timeFrame: 7, 15, 20 minutes post-CAC
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Ophthalmic Research Associates
state: Massachusetts
Study officials:
affiliation: American board of Ophthalmology
name: Gail L Torkildsen, MD
role: PRINCIPAL_INVESTIGATOR
References: