Phase 4
N=11
Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT01534195 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Ocular Itching Change From Baseline to Day 11 — -1.1; -0.45 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Prednisolone Sodium Phosphate Ophthalmic Solution 1% (Drug); Tears Naturale II Ophthalmic Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ORA, Inc.
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Itching Change From Baseline to Day 11 |
-1.1; -0.45 | — |
| SECONDARY Conjunctival Redness Change From Baseline to Day 11 |
-0.69; 0.40 | — |
| SECONDARY Episcleral Redness Change From Baseline to Day 6 |
-1.0; 0.45 | — |
| SECONDARY Ciliary Redness Change From Baseline to Day 6 |
-0.94; 0.30 | — |
Summary
The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication,
Prednisolone, assessed by the following measures:
* Ocular itching
* Conjunctival redness
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 (NCT01534195). 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.