Comparison performance of preserved versus unpreserved Levocabastin eyedrops in allergen challenge

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN68968150

Enrollment

Registered

2010-03-25

Start date

2007-10-29

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Conjunctivitis Eye Diseases Acute atopic conjunctivitis

Interventions

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 o

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

France

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026