The response of the eye to different ocular allergy eyedrops
Effect and time course of topical ketotifen 0.025% and prednisolone sodium phosphate 0.5% on ocular serface immune cells density, morphology, dynamic behaviour ,and topographical distribution in participants with allergic conjunctivitis
The University of New South Wales
90 participants
Nov 17, 2023
Interventional
Conditions
Summary
The prevalence of ocular allergies is increasing worldwide, affecting individuals’ quality of life and causing a significant socioeconomic burden. Allergic conjunctivitis can be managed using a range of treatment options. Ocular inflammatory cell (e.g., dendritic cell) play a substantial role in initiating the immune response in the setting of ocular allergies. The proposed study will be single centre, double-blinded, randomised, placebo-controlled, parallel group clinical trial. All participants will go through a washout period for 1 week using topical 0.25% polyethylene glycol 400 eyedrops (lubricant eyedrops) before starting the trial interventions. This study consists of three arms; arm 1 will be given topical ketotifen 0.025% eyedrops; arm 2 will be given prednisolone sodium phosphate 0.5% eyedrops; the placebo group will be given topical 0.4% polyethylene glycol 400, 0.3% propylene glycol eyedrops. All participants will remain on the trial interventions for 14 days. Assessment of the trial outcomes will take place pre-treatment, 24 hours, 7 days and 14 days after starting the treatment, 7 days and 14 days post-treatment. Both investigators and participants will be double-blinded to the group and treatment allocation until the results have been analysed.
Eligibility
Inclusion Criteria4
- Be at least 18 years of age or older.
- Positive result in the skin prick test.
- All participants must have current active allergic conjunctivitis symptoms (including itchy eyes or watery eyes or burning feeling or feeling like there is dirt or grit in your eyes) or signs (including redness or conjunctival chemosis or conjunctival papillae or conjunctival follicles), with or without a prior diagnosis of ocular allergy or hay fever.
- Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Exclusion Criteria13
- Severe allergic conjunctivitis (reflective from the total symptoms scores of the Mini-RQLQ and OSDI questionnaires) including vernal keratoconjunctivitis and atopic keratoconjunctivitis.
- Negative result in the skin prick test.
- Severe asthma.
- Severe eczema.
- Past anaphylactic episode.
- Previous allergic reaction to any component of topical eyedrops used in this study including benzalkonium chloride preservative.
- Pregnant or breastfeeding/childbirth within three months from the date of recruitment.
- Regular contact lens wear (wearing contact lenses for at least two or more full days in a week).
- All other ocular surface diseases except allergic conjunctivitis.
- Ocular diseases that involve the cornea.
- Active intraocular inflammation.
- History of corneal refractive surgery.
- Systematic conditions affecting the ocular surface include diabetes, thyroid disorder, rheumatoid arthritis and Sjogren's syndrome.
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Interventions
Arm 1: In this arm, participants will be given unpreserved unit dose ketotifen 0.025% (250 µg in 1mL) eyedrops. Participants will be instructed to put one drop in each eye for the duration of 14 days. Arm 2: In this arm, participants will be given unpreserved prednisolone sodium phosphate 0.5% eyedrops. Participants will be instructed to put one drop in each eye for the duration of 14 days. Monitor adherence to the intervention: The Investigator will maintain a participants Medicine Dispensing Log detailing the medication numbers and dates of medication dispensed for each participant during the course of the trial. Unused medications and control eyedrops at the end of the study will be destroyed at the trial site in accordance with local requirements and when site operating procedures permits after the drug accountability has been finalised and signed-off by the Investigator. Participants will be asked to complete a washout period of 1 week duration before the treatment period for which they will be given topical 0.25% polyethylene glycol 400 eyedrops (lubricant eyedrops) and will be asked to put one drop, twice daily in each eye for 1 week. During the post-treatment follow-up visits (7 and 14 days after stoping the treatment), participants will be given topical 0.25% polyethylene glycol 400 eyedrops (lubricant eyedrops) as rescue medication and asked to use them when required.
Locations(1)
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ACTRN12623001119684