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Table 1 Inclusion and exclusion criteria

From: Dual inhibition of complement component 5 and leukotriene B4 by topical rVA576 in atopic keratoconjunctivis: TRACKER phase 1 clinical trial results

Inclusion criteria

Exclusion criteria

1. Aged 18 and above

1. Eye surface disease other than AKC

2. Diagnosis of moderate to severe AKC with a composite symptom/sign score from one eye of ≥ 18 out of 33 (see Clinical Scoring 17.1)

2. Contact lens use during the study

3. Will have had maximal topical therapy for at least 3 months without improvement but will not currently be receiving systemic immunotherapy

3. Complete or partial tarsorrhaphy. If such a procedure becomes necessary during the course of the trial patients may remain in the trial providing that at least 50% of the eye surface remains visible to slit lamp examination

4. History of atopy other than ocular (dermatitis, asthma, hay fever)

4. Ankyloblepharon of any degree at entry to the trial

5. Willing to give informed consent

5. Known or suspected ocular malignancy

6. Willing to use highly effective contraceptive precautions for the duration of the study and for 90 days after the last dose of IMP

6. Active ocular infection at entry to the trial. Patients with eye surface bacterial, viral, fungal or protozoal infection may enter the trial after elimination of the infection as confirmed by eye swabs

7. Willing to avoid prohibited medications for duration of study (see list of prohibited medications)

7. Known or suspected uveitis

8. All patients in the study must be receiving maximum topical ciclosporin (Ikervis)

8. Participation in any other clinical trial within 1 month of enrolment

9. All patients will be receiving a topical antihistamine (olopatadine hydrochloride) twice daily

9. Use of any of the following prohibited medications:

 Eculizumab

 Any other investigational complement inhibitor whether systemic or topical (e.g. RA101495)

 Montelukast

 Zafirlukast

 Pranlukast

 Zileuton

 Hypericum perforatum (St John’s wort)

10. All patients may use an eye lubricant pro re nata (p.r.n.)

10. Corneal perforation

 

11. Uncontrolled glaucoma (increase in dose of glaucoma medication or surgical intervention for glaucoma within 3 months prior to entry)

 

12. Pregnancy (females)

 

13. Breast feeding (females)

 

14. Known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom)

 

15. Use of topical optical steroids within 14 days of the Screening Visit

 

16. Failure to satisfy the PI of suitability to participate for any other reason