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This study will examine the tolerability and toxicity of topically applied Nepafenac 0.3% vs ketorolac 0.5% among patients undergoing cataract surgery.
Full description
This will be a randomized, prospective, controlled, open-label study, comparing the tolerability and toxicity of two commercially available non-steroidal anti-inflammatory eye drops, nepafenac 0.3% and ketorolac 0.5% (generic formulation). The study will involve one eye of each subject. The study will follow good clinical practices (GCP). The primary outcome measure will be tolerability of the study medication as measured by the eye drop comfort survey instrument.
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Inclusion and exclusion criteria
Inclusion Criteria:
Exclusion Criteria
Active, systemic or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the questions in the survey and examination findings.
Any of the following ocular (eye or eyelid) conditions in either eye within 1 Months prior to the enrollment visit:
Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis
Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
Eyelid abnormalities that significantly affect lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy)
Participation in another ophthalmic clinical trial involving a therapeutic drug or device within 30 days prior to the distribution of the survey
Participation in this trial in the same patient's fellow eye.
Patients who are pregnant or breastfeeding or who may become pregnant during participation in the study.
Primary purpose
Allocation
Interventional model
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200 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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