Abstract | PURPOSE: METHODS: The study was conducted multinationally according to a triple-masked parallel design in 95 VKC patients, with assessments at baseline then monthly during the three months of treatment. The primary efficacy variables were a Physician's Clinical Judgement Scale and a Patient's Overall Judgement Scale of improvements from baseline. Signs and symptoms of VKC were also assessed. RESULTS: Both primary efficacy variables showed significantly greater overall improvement of VKC from baseline with lodoxamide than levocabastine. The superiority of lodoxamide was demonstrated by the Physician's Clinical Judgement Scale at months 2 and 3, with a trend, at month 1, and by the Patient's Overall Judgement Scale at months 1, 2 and 3. All signs and symptoms of VKC improved significantly from baseline at all time points, regardless of treatment (p<0.001). However, relative to levocabastine, conjunctival discharge, photophobia and lacrimation were significantly reduced by lodoxamide at months 1, 2 and 3, itching at months 2 and 3, and bulbar conjunctiva at month 3. The temporal improvement of superior tarsal papillae did not differ significantly between treatments. Both were well tolerated. CONCLUSIONS:
|
Authors | P Verin, R Allewaert, J C Joyaux, E Piozzi, J Koliopoulos, E Bloch-Michel, Lodoxamide Study Group |
Journal | European journal of ophthalmology
(Eur J Ophthalmol)
2001 Apr-Jun
Vol. 11
Issue 2
Pg. 120-5
ISSN: 1120-6721 [Print] United States |
PMID | 11456011
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Ophthalmic Solutions
- Piperidines
- Suspensions
- levocabastine
- Oxamic Acid
- lodoxamide ethyl
|
Topics |
- Adolescent
- Adult
- Anti-Allergic Agents
(administration & dosage, adverse effects, therapeutic use)
- Child
- Child, Preschool
- Conjunctiva
(drug effects)
- Conjunctivitis, Allergic
(drug therapy, physiopathology)
- Double-Blind Method
- Female
- Histamine H1 Antagonists
(administration & dosage, adverse effects, therapeutic use)
- Humans
- Male
- Ophthalmic Solutions
- Oxamic Acid
(administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
- Piperidines
(administration & dosage, adverse effects, therapeutic use)
- Safety
- Suspensions
- Treatment Outcome
|