A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy
- Conditions
- Allergic Conjunctivitis
- Interventions
- Drug: Tears Naturale ® (Placebo)
- Registration Number
- NCT02308501
- Lead Sponsor
- ORA, Inc.
- Brief Summary
A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft ® as Measured by In-Vivo Confocal Microscopy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- Have a positive history of ocular allergies and a positive skin test to protocol defined allergens
- Have a positive CAC reaction at Visit 1
- Have a positive conjunctival inflammation score at Visit 1
- May not use disallowed medications in specified washout period
- May not have an ocular or system disease the investigator feels with impact subject safety or trial parameters
- May not have active ocular infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lastacaft ® Lastacaft ® One drop Lastacaft ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2 Tears Naturale ® Tears Naturale ® (Placebo) One drop Tears Naturale ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2
- Primary Outcome Measures
Name Time Method Conjunctival Inflammation at 1 Hour (+30 Minutes) Post CAC on Day 1 1 hour (+30 minutes) post CAC on Day 1 Conjunctival Inflammation was assessed by a trained technician post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0 = best \[least inflammation\] and 4 = worst \[most inflammation\]).
The Conjunctival Inflammation was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye Conjunctival Inflammation score, and the Conjunctival Inflammation score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye Conjunctival Inflammation score.Conjunctival Inflammation 1 Hour (+30 Minutes) Post CAC on Day 2 1 hour (+30 minutes) post CAC on Day 2 Conjunctival Inflammation was assessed by a trained technician post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0 = best \[least inflammation\] and 4 = worst \[most inflammation\]).
The Conjunctival Inflammation was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye Conjunctival Inflammation score, and the Conjunctival Inflammation score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye Conjunctival Inflammation score.
- Secondary Outcome Measures
Name Time Method Ocular Itching on Day 1 (15 Minutes Post-study Medication Instillation) 15 minutes post-study medication instillation CAC was performed 15 minutes after study medication instillation. Ocular Itching was assessed by the patient on a 0-4 scale (0 = best \[no itching\] to 4 = worst \[severe itching\]). The ocular itching score was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye ocular itching score, and the ocular itching score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye ocular itching score.
Ocular Itching on Day 2 (15 Minutes Post-study Medication Instillation) 15 minutes post-study medication instillation CAC was performed 15 minutes after study medication instillation. Ocular Itching was assessed by the patient on a 0-4 scale (0 = best \[no itching\] to 4 = worst \[severe itching\]). The ocular itching score was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye ocular itching score, and the ocular itching score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye ocular itching score.