Comparison performance of preserved versus unpreserved Levocabastin eyedrops in allergen challenge

Completed

• Conditions: Allergic Conjunctivitis; Eye Diseases; Acute atopic conjunctivitis

• Registration Number: ISRCTN68968150
• Lead Sponsor: aboratoire Chauvin, Bausch & Lomb Inc. (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-25
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

1. Healthy
2. Volunteers
3. Male or female
4. 18-50 years old
5. History of allergic conjunctivitis
6. Normal screening ocular examination
7. Best corrected distance visual acuity (VA) must be 8/10 (Monoyer scale) or more
8. Intraocular pressure (IOP) must be <21 mm Hg
9. Positive screening conjunctival provocation test (CPT) including at least moderate itching and hyperaemia
10. Women of childbearing potential must have a negative pregnancy test
11. Contact lens wearers must agree to not wear contact lenses when CPTs are conducted

Exclusion Criteria

1. Any ocular or systemic disease
2. Known hypersensitivity to the study drugs or their components
3. Allergic conjunctivitis due to an allergen other than grass pollen
4. Subjects who don't have discontinued use of certain medications up to 6 weeks prior to study entry
5. Subjects who have previously undergone hyposensitization therapy for grass pollen within 3 months prior to study entry
6. Subjects who have previously undergone ocular laser treatment or ocular surgery within 6 months prior to study entry

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sum score for conjunctival hyperaemia (Grade 0-3) and itching (Grade 0-4) at 3, 5, and 10 minutes after CPT at Visits 3 and 4

Secondary Outcome Measures

Name	Time	Method
1. Individual scores for the following, at 3, 5, and 10 minutes after CPT at Visit 3 and 4<br>1.1. conjunctival hyperaemia<br>1.2. itching<br>1.3. eyelid swelling<br>1.4. conjunctival chemosis<br>1.5. tearing<br>2. Proportion of eyes with a late phase reaction within 24 hours after CPT at Visit 3 and 4<br>3. Safety Endpoints:<br>4. Visual acuity (Monoyer scale)<br>5. Slit lamp<br>6. IOP<br>7. Subjective tolerance upon treatment administration<br>8. Adverse events