Assessing the Efficacy of Maxidex® and Patanol® for the Treatment of Allergic Conjunctivitis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01119287
• Date of registration: 04/05/2010
• Prospective Registration: No
• Primary sponsor: Alcon Research
• Public title: Assessing the Efficacy of Maxidex® and Patanol® for the Treatment of Allergic Conjunctivitis
• Scientific title: A Randomized, Double-Masked, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of Maxidex® (0.1% Dexamethasone) Ophthalmic Suspension and Patanol® (0.1% Olopatadine Hydrochloride) Ophthalmic Solution for the Treatment of Allergic Conjunctivitis in an Environmental Exposure Chamber (EEC) Model
• Date of first enrolment: March 2010
• Target sample size: 180
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01119287
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 64 Years
Gender: All

Health Condition(s) or Problem(s) studied

Allergic Conjunctivitis

Intervention(s)

Drug: Dexamethasone 0.1% ophthalmic suspension

Other: Inactive ingredients, used as placebo

Drug: Olopatadine hydrochloride 0.1% ophthalmic solution

Primary Outcome(s)

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 [Time Frame: Baseline (Visit 3, pre-treatment); Visit 6 (Day 9 of treatment)]

Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo [Time Frame: Baseline (Visit 2, pre-treatment), Visit 5 (Day 8 of treatment)]

Secondary ID(s)

C-10-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/03/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01119287