Comparison performance of preserved versus unpreserved Levocabastin eyedrops in allergen challenge
| ISRCTN | ISRCTN68968150 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68968150 |
| Secondary identifying numbers | 523 |
- Submission date
- 26/02/2010
- Registration date
- 25/03/2010
- Last edited
- 13/09/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Didier Chassard
Scientific
Scientific
SGS Aster
3-5 Rue E. Millon
Paris
75015
France
Study information
| Study design | Single centre contralateral double blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| 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 |
| Study acronym | Levocabastine |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 29/10/2007 |
| Completion date | 25/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | 92 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 29/10/2007 |
| Date of final enrolment | 25/03/2008 |
Locations
Countries of recruitment
- France
Study participating centre
SGS Aster,
Paris
75015
France
75015
France
Sponsor information
Laboratoire Chauvin, Bausch & Lomb Inc. (France)
Industry
Industry
416, rue Samuel Morse
Montpellier Cedex 2
34961
France
"ROR" |
https://ror.org/018qejt38 |
|---|
Funders
Funder type
Industry
Laboratoire Chauvin, Bausch & Lomb Inc. (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
