Efficacy and safety of Hydrocortison-POS N1% and 2.5% versus Ficortril 0.5% in the treatment of acute inflammation of the ocular surface or adnexa for which steroid treatment is indicated

Completed

• Conditions: on-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

• Registration Number: ISRCTN15464650
• Lead Sponsor: RSAPHARM Arzneimittel GmbH (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-18
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 411

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified