Non-infectious disease of the eye and ocular adnexa, i.e., seasonal or perennial allergic conjunctivitis, acute allergic blepharitis or blepharoconjunctivitis, or allergic lid oedema, with acute inflammation of the ocular surface or adnexa Eye Diseases Blepharoconjunctivitis
Conditions
Interventions
Patients were randomly allocated to one of three study arms:
Arm 1: Hydrocortisone acetate 0.5 % (Ficortril® 0.5%) (n=133 patients)
Arm 2: Hydrocortisone acetate 1 % (Hydrocortison-POS® N 1%) (n= 1
Sponsors
URSAPHARM Arzneimittel GmbH (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female or male outpatients aged 18 to 75 years old (inclusive) with a non-infectious disease of the eye and ocular adnexa, i.e., seasonal or perennial allergic conjunctivitis, acute allergic blepharitis or blepharoconjunctivitis, or allergic lid oedema, with acute inflammation of the ocular surface or adnexa for which topical steroid treatment is advisable 2. A clinical sum score of signs and symptoms of at least 10 with at least one item scored as ?2? (moderate) or ?3? (severe) at baseline.
Exclusion criteria
Exclusion criteria: 1. Incapability of understanding the language in which the written patient information is given 2. Presence or history of drug or alcohol abuse 3. Presence of any malignancy during the past 5 years 4. The patient is a woman of childbearing potential who does not use a reliable method of contraception 5. The patient is a pregnant or breast feeding woman 6. Participation in a concurrent clinical trial or in another trial within the past 4 weeks 7. Previous participation in this trial or the patient is the investigator him/herself 8. Pre-treatment which is not permitted 9. Concomitant treatment which is not permitted 10. Allergy or hypersensitivity to any ingredients of the trial medication 11. Any contraindication for the use of steroids: e.g. bacterial, some specific viral or fungal eye infections, glaucoma [except open-angle glaucoma with controlled Intraocular pressure (IOP)], cataract (except early-stage cataract), etc. 12. Findings with fluorescein corneal staining at baseline which prohibit steroid treatment 13. Eye discharge (yellowish) with score of 1 or above at baseline as assessed by the investigator 14. Ocular injury and/or ocular surgery within 3 months prior to trial participation (preceding intra ocular laser surgery expressively permitted) 15. Systemic or topical steroids within 1 month prior or during trial participation 16. Contact lenses 17. Changes in eye hygiene measures after study inclusion 18. Any systemic disease which prohibits steroid treatment, e.g. severe osteoporosis, unstable diabetes mellitus, Cushing syndrome, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary and secondary outcomes were measured by standard ophthalmological methods. The ophthalmologist assessed clinical signs and symptom by score values during a slit lamp examination. Additionally visus and intraocular pressure were measured. Patient was also asked to assess the local tolerance by a questionnaire. Ophthalmological slit lamp examination: Time to first occurrence of at least 50% in sum score of signs and symptoms | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy The three treatment groups were compared pair-wise with regard to the differences in subscores of objective and subjective signs and symptoms between end of treatment and baseline, as well as the differences in time to 50% reduction of objective signs and subjective symptoms, responders and remitters, differences in the scores of single items of the CSS, treatment duration, and global assessments of efficacy. Safety To assess the different outcomes of the three treatments on intra-ocular pressure (IOP), to evaluate tolerability by (relative) frequency of (serious) adverse events, abnormalities of vital signs, visual acuity test and fluorescein corneal staining in the three treatment groups, and to compare global assessment of tolerability between each pair of the three treatment groups 1. Sum score of subjective and objective signs 2. Sum score of objective signs 3. Sum score of subjective symptoms 4. Time to first occurrence of at least 50% reduction in sum score for objective signs 5. Time to first occurrence of at least 50% reduction in sum score for subjective signs 6. Responder (CSS improvement by = 50%) and remitter (CSS=0) rates 7. Treatment duration until CSS=0 8. Global rating of efficacy 9. Intra-ocular pressure 10. Visual acuity 11. Vital signs 12. Fluorescein corneal staining 13. Adverse events 14. Global rating of tolerability Measurements were done at baseline and on day 2, 4, 7, 10, (and if required) 14. | — |
Countries
Ukraine
Outcome results
None listed