Phase 4
N=36
Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT00689078 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Ocular Itching at Baseline (Day 0) — 2.53; 3.08; 2.61; 2.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Prednisolone Acetate 1% (Drug); Prednisolone Acetate 0.12% (Drug); Loteprednol Etabonate 0.2% (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ORA, Inc.
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Itching at Baseline (Day 0) |
2.53; 3.08; 2.61; 2.5; 2.92; 3.47 | — |
| PRIMARY Ocular Itching at Day 6 |
2.17; 2.19; 2.06; 2.33; 2.44; 2.59 | — |
| PRIMARY Ocular Itching at Day 7 |
2.11; 2.28; 2.09; 2.03; 2.11; 2.69 | — |
| PRIMARY Ocular Itching at Day 27 |
2.14; 2.43; 1.75; 2.03; 2.17; 2.64 | — |
| PRIMARY Ocular Itching at Day 28 |
1.83; 2.25; 2.03; 1.75; 1.97; 2.64 | — |
| PRIMARY Ocular Redness at Baseline (Day 0) |
2.11; 2.11; 1.86; 2.08; 2.33; 2.31 | — |
| PRIMARY Ocular Redness at Day 6 |
2; 2.22; 1.84; 2.11; 1.97; 2.41 | — |
| PRIMARY Ocular Redness at Day 7 |
2.08; 1.53; 1.59; 1.59; 1.83; 1.69 | — |
| PRIMARY Ocular Redness at Day 27 |
1.72; 2.14; 1.44; 1.56; 1.72; 2.11 | — |
| PRIMARY Ocular Redness at Day 28 |
1.58; 1.96; 1.69; 1.81; 1.81; 2.11 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00689078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.