New Global Study of Atopic Keratoconjunctivitis (AKC)
The AKC Study
Four New Zealand ophthalmologists are participating in a global study on a new eye drop formulation for Atopic Keratoconjunctivitis. There are 3 New Zealand sites for this study. Dr Andrew Logan is the lead investigator at the Wellington site, Dr Adam Watson and Dr Trevor Gray are at the Auckland site of the study (at Eye Institute), and in Christchurch, Dr Malcolm McKellar is running a third study site.
All three sites are seeking AKC sufferers to participate in the study. Candidates who are eligible to participate will benefit from close monitoring of their condition for the 12-month duration of the study, including the provision of the study medication. The patient will receive comprehensive ophthalmic care and the referrer will receive regular reports on their progress. Patients will be reimbursed for their travel to and from the clinical site on the days of their visits.
The patient is randomly assigned to either a study medication or a placebo for 3 months, followed by an open label phase in which all study candidates receive the new formulation for 9 months.
The most important inclusion criteria are:
- Clinical diagnosis of AKC including atopic dermatitis (or a history of dermatitis)
- Punctate Keratopathy
- Age > 12 years
- Best corrected visual acuity of 20/800 or better in both eyes
Significant exclusion criteria include:
- Uncontrolled systemic disease (except for atopic dermatitis)
- Pregnancy
- Current enrollment in an investigational drug or device study
- History of inflammatory corneal ulcers not related to AKC
- Active ocular disease not related to AKC
The study involves 12 visits to the clinic and lasts approximately 12½ months. If you are aware of any patient with AKC the study centers would be grateful for your referral so that they can contact the patients and discuss participation further.
Atopic Keratoconjunctivitis
AKC is a rare, sight-threatening, bilateral inflammatory, external ocular disease. It is a relatively rare condition that typically affects young men with atopic dermatitis. AKC persists for many years and has a high rate of corneal complications, keratoconus and cataract.
Signs of AKC include:
- Red, thickened and fissured lids. Patients may have associated staphylococcal blepharitis
- Tarsal conjunctival infiltration may give the palpebral conjunctiva a pale featureless appearance. Cicatrizing conjunctivitis may develop in advanced cases
- Chemosis, limbal hyperemia, papillary hypertrophy during exacerbations
- Keratopathy that begins as punctate epithelial erosions and progresses to persistent epithelial defects and potentially anterior stromal scars with peripheral vascularisation. This can be complicated by herpes simplex and microbial keratitis
Current Management of AKC
Primary Treatment
Avoidance of the antigen, cold compresses and lubrication are simple initial steps to take in the treatment of allergic eye problems. AKC sufferers may still benefit from introducing these steps despite the severity of the problem.
Secondary Treatment
The use of topical decongestants, antihistamines, mast-cell stabilising agents and antiinflammatory agents are considered by most to be secondary treatments.
Tertiary Treatment
This includes the use of topical corticosteroids, topical immuno-suppressants, and experimental treatments. This level of treatment is reserved for more severe or unresponsive cases of ocular allergy including AKC.
If you have any questions about the study or have a patient who could be a candidate, please feel free to contact the doctors or their study coordinators.
Wellington: Dr Andrew Logan (lead investigator) - or 04 385 8833
Auckland: Dr Adam Watson and Dr Trevor Gray - or or 09 522 2125
Christchurch: Dr Malcolm McKellar - or 03 366 1682.
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