Cataract
Conditions
Keywords
cataract
Brief summary
This study will examine the tolerability and toxicity of topically applied Nepafenac 0.3% vs ketorolac 0.5% among patients undergoing cataract surgery.
Detailed 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.
Interventions
DRUGnepafenac 0.3%
Patients in this group will receive nepafenac 0.3% eye drops once daily after cataract surgery.
DRUGketorolac
Patients in this group will receive ketorolac 0.5% eye drops four times daily after cataract surgery.
Sponsors
Alcon Research
MDbackline, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Patients 18 years and older currently undergoing femtosecond or manual cataract surgery with or without astigmatic keratotomy. 2. Patients willing to take an electronic survey about their tolerability of either study medication.
Exclusion criteria
1. 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. 2. Any of the following ocular (eye or eyelid) conditions in either eye within 1 Months prior to the enrollment visit: 1. Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgery procedure. 2. Clinically significant ocular trauma. 3. Active ocular Herpes simplex or Herpes zoster (eye or eyelid) infection. 4. Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) 5. Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye) 3. Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis 4. Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis) 5. Eyelid abnormalities that significantly affect lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) 6. 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) 7. Participation in another ophthalmic clinical trial involving a therapeutic drug or device within 30 days prior to the distribution of the survey 8. Participation in this trial in the same patient's fellow eye. 9. Patients who are pregnant or breastfeeding or who may become pregnant during participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of nepafenac vs ketorolac | 14-28 days | Patients will fill out a survey describing eye drop tolerability at 14-28 days |
Countries
United States
Outcome results
None listed