Phase 4 Completed N=16 Randomized Quadruple-blind Prevention

Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model

Chronic Allergic Conjunctivitis

Source: ClinicalTrials.gov NCT01730872 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2019

Primary outcomePrimary: Inflammation Change From Baseline to Day 6 — -1.2; -0.19 score 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 This can indicate results are unpublished — a known publication-bias signal.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: Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival redness

Outcome Measures

Outcome	Result	p-value
PRIMARY Inflammation Change From Baseline to Day 6	-1.2; -0.19	—
SECONDARY Ocular Itching Change From Baseline to Day 6	-1.1; -1.0	—
SECONDARY Ocular Redness Change From Baseline to Day 6	-1.1; 0.31	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01730872). 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.