Assessment of the effectiveness and safety of Bibrocathol 2% eye ointment (Bibrocathol-POS 2%) in the treatment of chronic blepharoconjunctivitis

Phase 3

Completed

• Conditions: Chronic blepharoconjunctivitis; Eye Diseases; Blepharoconjunctivitis

• Registration Number: ISRCTN14084351
• Lead Sponsor: RSAPHARM Arzneimittel GmbH

Brief Summary

2022 Results article in https://doi.org/10.17352/2455-1414.000096 (added 09/09/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-10-28
• Study Start: 2021-03-08
• Last Update Posted: 19 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Written informed consent
2. Ambulatory male and female patients =18 years of age
3. Diagnosis of chronic blepharoconjunctivitis
4. A summarised score of signs and symptoms (sum score of severity of lid oedema, lid erythema, debris, hyperemia and pouting of Meibomian glands and additionally the patient’s assessment of ocular discomfort) of = 18 at baseline
5. Ability of the patient to cooperate (able to understand the provided information about the clinical trial, willing to comply with the requirements of the study protocol)
6. Consent to use adequate contraception
7. Women using adequate contraception with a negative pregnancy test (for women with childbearing potential), or women who had menopause 2 years before the start of the study or earlier

Exclusion Criteria

Non-inclusion criteria:
Ocular conditions:
1. Chronic blepharoconjunctivitis requiring antibiotic treatment
2. Therapy-resistant chronic blepharoconjunctivitis
3. Acute ocular and/or follicle or lid infection or active ocular inflammation other than blepharoconjunctivitis
4. Irritations of the outer eye that are related to corneal damage (e. g. erosions, injuries, burns)
5. Abnormal eyelid anatomy (other than due to chronic blepharoconjunctivitis)
6. Ocular surgery within 90 days (trauma, intraocular surgery, refractive surgery, palpebral surgery (e.g. ectopium OP), etc)
7. Severe dry eye syndrome also due to systemic diseases
8. Allergic eye disease
9. Glaucoma
10. IOP =21 mmHg (non-contact tonometry)
11. Patients with only one eye

Systemic condition:
12. Known hypersensitivity to the investigational product or any of the ingredients from the composition of the investigational product (or of placebo)
13. Severe systemic disease (incl. rheumatoid arthritis, ankylosing spondylitis)
14. Subjects with a history of malignancy of any organ system, treated or untreated, within the past 5 years, whether or not evidence of local recurrence or metastases exists

Concomitant medication:
15. Oral or topical antibiotics 2 weeks prior to and during the trial
16. Any other ocular antiseptics during the trial
17. Topical ocular or systemic corticosteroids 2 weeks prior to and during the trial (except chronic use of inhalative corticosteroids if on stable dose 1 month prior to and during the trial)
18. Topical ocular and systemic NSAIDs 2 weeks prior to and during the trial (low-dose oral acetylsalicylic acid and occasional use of painkillers is allowed)
19. Local ocular use of antihistamines 1 month and prior to and during the trial
20. Ocular a-sympathomimetics 1 month and prior to and during the trial

Other:
21. Patients who anticipate changes in their ongoing regimen of concurrent systemic therapies that could affect trial parameters
22. Pregnant or breastfeeding women
23. Women with childbearing potential, not using a reliable and medically accepted method of contraception (no pregnancy test is required in women, being 2 years after menopause)
24. Any systemic or ocular medical or physical condition which, in the investigator’s opinion, would preclude the participant from adhering to the protocol or completing the trial per protocol
25. Patients participating in another clinical trial at the same time
26. Patients taking any investigational product during the last 28 days
27. Patients already once included in this trial

1. Recall of the informed consent by the patient
2. Necessity to discontinue study treatment /placebo due to the occurrence of adverse events and/or exacerbation of concurrent diseases which prevent further participation in the study
3. Applicability of adjunctive therapy which is not permitted within this Protocol
4. Other con

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Signs of chronic blepharoconjunctivitis, expressed as a sum score which comprises the severity of:<br> 1. Lid oedema measured using slit-lamp examination at screening, day 1, day 7 and day 15<br> 2. Lid erythema measured using slit-lamp examination at screening, day 1, day 7 and day 15<br> 3. Debris measured using slit-lamp examination at screening, day 1, day 7 and day 15<br> 4. Hyperemia measured using slit-lamp examination at screening, day 1, day 7 and day 15<br> 5. Pouting of Meibomian glands assessed by the investigator at screening, day 1, day 7 and day 15<br>

Secondary Outcome Measures

Name	Time	Method
<br> The individual parameters:<br> 1. Lid oedema measured using slit-lamp examination at screening, day 1, day 7 and day 15<br> 2. Lid erythema measured using slit-lamp examination at screening, day 1, day 7 and day 15<br> 3. Debris measured using slit-lamp examination at screening, day 1, day 7 and day 15<br> 4. Hyperemia measured using slit-lamp examination at screening, day 1, day 7 and day 15<br> 5. Pouting of Meibomian glands measured by investigator assessment at screening, day 1, day 7 and day 15<br>