A Phase 4 interventional study of Topical tacrolimus in Vernal Keratoconjunctivitis, sponsored by The Eye Center and The Eye Foundation for Research in Ophthalmology. Status unknown at 1 site in Saudi Arabia. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2015-11-24.
Sponsored by The Eye Center and The Eye Foundation for Research in Ophthalmology · Phase 4, Interventional, and Treatment
The main aim of this study is to evaluate the efficacy and safety of topical tacrolimus 0.01% eyedrops in patients with vernal keratoconjunctivitis.
A total of 20 patients with bilateral symmetrical vernal keratoconjunctivitis will be included. Each patient will undergo a complete ophthalmologic evaluation. Patient will be placed at random on topical Tacrolimus 0.01% ophthalmic solution in one eye and placebo eyedrops in the fellow eye. Patients will undergo ophthalmologic examination at one week and after one month. Photos will be taken. The outcome measures include graded symptoms, graded signs, and laboratory investigations. Symptoms of itching, redness, foreign body sensation, tearing and discharge following will be recorded before and after treatment. The grading of clinical signs of conjunctival hyperemia, conjunctival papillary hypertrophy, perilimbal infiltrates, Trantas dots, superficial punctate keratopathy will be recorded before and after treatment. Conjunctival surface temperature will be determined before and after treatment. Conjunctival scrapings will be stained with Giemsa and will be assessed before and after therapy and number of eosinophils per hpf will be determined and recorded.
117 studies on the registry are indexed under Keratoconjunctivitis; 4 are open to participants now.
This study's planned enrollment of 20 is below the median of 52 across 91 interventional studies indexed under Keratoconjunctivitis.
Browse Keratoconjunctivitis studies →The Eye Center and The Eye Foundation for Research in Ophthalmology is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
20 eyes with active Vernal Keratoconjunctivitis
Drug: Topical tacrolimus
20 eyes with active Vernal Keratoconjunctivitis
Drug: Topical tacrolimus
Topical tacrolimus 0.01% twice daily for one month
Also known as: Tacrolimus eye drops
The efficacy of Topical Tacrolimus in Vernal Keratoconjunctivitis
To evaluate the efficacy of topical tacrolimus 0.01 eye drops in patients with vernal keratoconjunctivitis in symptoms of redness, itching, foreign body sensation and discharge and signs of conjunctival hyperemia,perlimbal infiltrates, Trantas dots and papillary reaction
Time frame: Five months
This study is status unknown, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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The Eye Center and The Eye Foundation for Research in Ophthalmology