Phase 4
Completed N=11
Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
Source: ClinicalTrials.gov NCT01534195 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Ocular Itching Change From Baseline to Day 11 — -1.1; -0.45 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
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 | — |
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. Informational only — not medical advice.