Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model

Allergic Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689078
• Other study ID #: 08-003-05
• Status: Completed
• Phase: Phase 4
• Start date: May 2008
• Est. completion date: June 2008

Study information

• Verified date: August 2020
• Source: ORA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Prednisolone Acetate 1%
One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
• Prednisolone Acetate 0.12%
One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
• Loteprednol Etabonate 0.2%
One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
• Placebo
One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.

Locations

Country	Name	City	State
United States	Ophthalmic Research Associates	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Itching at Baseline (Day 0)	A baseline CAC was performed on Day 0. Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.	3, 5, 7 minutes post-CAC
Primary	Ocular Itching at Day 6	Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.	3, 5, 7 minutes post-CAC
Primary	Ocular Itching at Day 7	Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 7. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.	3, 5, 7 minutes post-CAC
Primary	Ocular Itching at Day 27	Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 27. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.	3, 5, 7 minutes post-CAC
Primary	Ocular Itching at Day 28	Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.	3, 5, 7 minutes post-CAC
Primary	Ocular Redness at Baseline (Day 0)	A baseline CAC was performed on Day 0. Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.	7, 15, 20 minutes post-CAC
Primary	Ocular Redness at Day 6	Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.	7, 15, 20 minutes post-CAC
Primary	Ocular Redness at Day 7	Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 7. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.	7, 15, 20 minutes post-CAC
Primary	Ocular Redness at Day 27	Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 27. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.	7, 15, 20 minutes post-CAC
Primary	Ocular Redness at Day 28	Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.	7, 15, 20 minutes post-CAC