Condition category
Eye Diseases
Date applied
26/02/2010
Date assigned
25/03/2010
Last edited
13/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Didier Chassard

ORCID ID

Contact details

SGS Aster
3-5 Rue E. Millon
Paris
75015
France

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 measures

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

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

Sponsor information

Organisation

Laboratoire Chauvin, Bausch & Lomb Inc. (France)

Sponsor details

416
rue Samuel Morse
Montpellier Cedex 2
34961
France

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes