Efficacy and safety of sodium cromolyn eye drops compared with placebo eye drops in patients with a history of allergic conjunctivitis using the Conjunctival Allergen Challenge model.

• Conditions: allergic conjunctivitis; MedDRA version: 9.1Level: LLTClassification code 10001709Term: Allergic conjunctivitis

• Registration Number: EUCTR2007-004473-26-FR
• Lead Sponsor: aboratoires Théa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

·Male or female aged from 18 to 45 years.
·Signed informed consent.
·Registered, or agreeing to be registered, in the national register of volunteers.
·Subject with a history of a allergic conjunctivitis for at least 2 years and with a positive allergic skin test ( for grass or ragweed or birch pollen, or cat hair and dander) or with a positive conjunctival allergen challenge within the previous 24 months of visit 1.
·Presenting with normal ocular examination of both eyes and without any ocular symptom.
·Subject able to understand the study instructions.
·Subject willing to comply with the study schedule and treatment

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-History of ocular herpes, retinal detachment, diabetic retinopathy or any retinal disease.
-History of ocular trauma, infection or inflammation within the last 3 months.
-Presence of any significant ocular symptom (notably itching > 1).
-Presence of one of the following abnormalities or pathologies detected at slit lamp examination:
·Conjunctival hyperaemia (score ³ 1).
·Any cornea abnormality including presence of at least 5 corneal punctuations stained by fluorescein (score 1b= Fluorescein – stained punctuations < 10% of the corneal surface and ³ 5 and < 10 punctuations).
·Chemosis (score ³ 1).
·Tearing (score ³ 1)
·Folliculo-papillary conjunctivitis (score ³ 1 after inferior and superior eye-lid eversion)·Conjunctival discharge (score ³ 1).
·Eyelid swelling (score ³ 1).
·Tyndall > 0
-History of ocular hypertension
-Presence of any ocular pathology such as dry-eye syndrome, blepharitis, iritis, uveitis or any other ocular infection.
- Extended contact lens wear (occasional wear is allowed before the study but not one week before the study or during the study).
-Known or suspected hypersensitivity to one of the components of the study medication, or to any other antiallergic, topical anaesthetic drugs and/or fluorescein.
-Current allergic pathology ongoing (i.e., status asthmaticus or moderate to severe allergic asthma)
-Desensitisation within the past 3 months
-Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine, neoplasic, haematological; immunosuppressive, infectious diseases, severe psychiatric illness, relevant cardiovascular abnormalities, etc… and/or any complicating factor or structural abnormality, judged by the investigator to be incompatible with the study.
-Current bronchitis.
-Ongoing tooth care.
-Recent acute illness with a recovery period within the 2 weeks prior to the inclusion day (Day 0).
-History of alcohol abuse (alcohol consumption > 50 g/day).
-Chronic cigarette smoking (= 10 cigarettes per day).
-Past or present history of drug abuse and/or excessive use of medications.

-Pregnancy, lactation.
-Pre-menopausal woman who is not using a reliable birth control method (oral contraceptives or coil) and is not surgically sterilised.
-Regular exposure to a smoky environment and/or air conditioning
-Application of eye make-up during the study
-Participation in any high-speed, intensive sports or water-sports from Day 0 to Day 21
-Inability of subject to understand the study procedures and thus inability to give informed consent.
-Non compliant subject (e.g. not willing to attend the follow-up visits, way of life interfering with compliance).
-Participation in another clinical study within the last 3 months. (Or still during the exclusion period of another clinical study.)
-Already included once in this study.
-Ward of court.
-Patient not covered by the Social Security scheme when existing in the concerned country.
-Subject has received more than the legal limit of 4 500,00 Euros of compensation for participating in clinical trials during the course of the previous 12 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified