Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
| Status: | Completed |
|---|---|
| Conditions: | Allergy, Ocular |
| Therapuetic Areas: | Ophthalmology, Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/17/2018 |
| Start Date: | May 2008 |
| End Date: | June 2008 |
Single Center, Randomized, Double-Masked Evaluation of the Efficacy of Prednisolone Acetate 1% Ophthalmic Suspension Compared to Prednisolone Acetate 0.12% Ophthalmic Suspension, Loteprednol Etabonate 0.2% Ophthalmic Suspension, and Placebo in a Modified CAC Model
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.
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.
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)
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)
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
We found this trial at
1
site
Click here to add this to my saved trials
