RecruitingPhase 3ACTRN12623001119684

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

Sponsor

The University of New South Wales

Enrollment

90 participants

Start Date

Nov 17, 2023

Study Type

Interventional

Conditions

Perennial allergic conjunctivitis Seasonal allergic conjunctivitis

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This clinical trial is comparing three different eye drops for treating allergic conjunctivitis — the red, itchy, watery eyes that come with hay fever and other allergies. The three treatments being tested are: ketotifen (an antihistamine eye drop), prednisolone (a steroid eye drop), and a placebo (a lubricating drop with no active medicine). Researchers want to understand how each treatment affects not just symptoms but also the immune cells in the eye that trigger the allergic response. Participants will use one of the three eye drops for 14 days, and their eyes will be assessed before treatment, during treatment, and two weeks after finishing, using specialised imaging techniques and symptom questionnaires. Neither participants nor researchers will know which treatment each person receives until the study ends. You may be eligible if you are 18 or older, have active symptoms of allergic conjunctivitis (itchy, watery, or red eyes), and have a positive skin prick allergy test. You are not eligible if you have severe allergic eye disease, are pregnant or breastfeeding, wear contact lenses regularly, have other eye conditions, or have systemic conditions like diabetes or rheumatoid arthritis. This study could help establish clearer guidelines for managing eye allergies more effectively.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

School of Optometry and Vision Science - Kensington

NSW, Australia

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ACTRN12623001119684