Phase 4
Completed N=170
Assessing the Efficacy of Maxidex® and Patanol® for the Treatment of Allergic Conjunctivitis
Source: ClinicalTrials.gov NCT01119287 ↗Enrolled (actual)
170
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcomePrimary: Mean Change From Baseline in Staff-Assessed Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)], Maxidex and Placebo — 18.120; 19.362; 16.823; 17.572 hours x units on a scale
Summary
The purpose of this study was to evaluate the efficacy of Maxidex and Patanol compared to placebo in patients with allergic conjunctivitis when exposed to controlled allergen levels in an Environmental Exposure Chamber (EEC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Staff-Assessed Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)], Maxidex and Placebo |
18.120; 19.362; 16.823; 17.572; 11.671; 15.786 | — |
| PRIMARY Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo |
4.776; 5.669; 5.904; 5.654; 2.630; 3.990 | — |
Eligibility Criteria
Inclusion Criteria
- At least 1 year history of allergic conjunctivitis.
- Ability to self administer ophthalmic drops.
- Ability to avoid use of disallowed medications during the entire study period and specified period prior to visit 1.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Presence of any ocular infection.
- Confirmed diagnosis of dry eye.
- Presence of glaucoma or ocular hypertension.
- Moderate to severe asthma.
- Any severe, unstable, or uncontrolled systemic disease.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01119287). 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.