Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
523
Study information
Scientific title
A Colateral, Double-Masked, Randomized Study to Evaluate Preservative-Free Levocabastine 0.05% Ophthalmic Solution When Compared to Preserved Levocabastin 0.05% Ophthalmic Suspension or Preservative-Free Levocabastine Ophthalmic Solution Vehicle During Allergen Challenge
Acronym
Levocabastine
Study hypothesis
Evaluation of efficacy and safety of Prerservative-free Levocabastine ophthalmic solution compared to Preserved Levocabastine ophthalmic suspension and Preservative-free Levocabastine ophthalmic solution vehicle in prevention of allergic conjunctivitis induced by ocular allergen challenge
Ethics approval
Approval received from the local ethics committee (Comité de Protection des Personnes CPP Ile de France III) on the 31st of July 2007 (Ref: CPP Dossier No 2445)
Study design
Single centre contralateral double blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Allergic Conjunctivitis
Intervention
1. Preservative-free Levocabastine 0.05% ophthalmic solution (formula LCM-1218)
2. Preserved Levocabastine 0.05% ophthalmic suspension (Levophta, formula LCM-1215)
3. Preservative-free Levocabastine ophthalmic solution vehicle (formula LCM-1228)
3/4 of patients will receive (1) in one eye and (2) in the second eye
1/4 of patients will receive (3) in one eye and (2) in the second eye
One drop of the applicable medication/placebo will be administered by study personnel at 10 min (Visit 3) or 4 hours (Visit 4) prior to CPT.
No further follow up.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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
1. Individual scores for the following, at 3, 5, and 10 minutes after CPT at Visit 3 and 4
1.1. conjunctival hyperaemia
1.2. itching
1.3. eyelid swelling
1.4. conjunctival chemosis
1.5. tearing
2. Proportion of eyes with a late phase reaction within 24 hours after CPT at Visit 3 and 4
3. Safety Endpoints:
4. Visual acuity (Monoyer scale)
5. Slit lamp
6. IOP
7. Subjective tolerance upon treatment administration
8. Adverse events
Overall trial start date
29/10/2007
Overall trial end date
25/03/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
92
Participant 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
Recruitment start date
29/10/2007
Recruitment end date
25/03/2008
Locations
Countries of recruitment
France
Trial participating centre
SGS Aster,
Paris
75015
France
Funders
Funder type
Industry
Funder name
Laboratoire Chauvin, Bausch & Lomb Inc. (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list