Cataract
Conditions
Brief summary
The purpose of this study is to compare the ability of two different topical NSAIDs (non-steroidal anti-inflammatory medications used for pain relief) to reach the back of the eye and to stop inflammation. The study will conclude on the day of your cataract surgery.
Interventions
DRUGAcular, Xibrom
1. Acular 5ml (in the eye)Instill one drop into the eye to be operated on four times a day at (6am, 12pm, 6pm, 12am) 2. Xibrom 5ml (in the eye) Instill one drop into the eye to be operated on two times a day (8am and 8pm)
Sponsors
Innovative Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Healthy Male/Female 21 years of age of older. 2. Patient understands and is willing to sign the written informed consent form 3. Likely to complete the entire course of the study. 4. Patient is scheduled to undergo cataract surgery 5. Female patients of childbearing potential must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation). 6. Patient is willing and able to administer eye drops and record the times the drops were instilled
Exclusion criteria
1. Patient has been using a topical NSAID within 1 week of study entry 2. Patient has a known sensitivity to any of the ingredients in the study medications 3. Patient has sight in only one eye 4. Patient has a history of previous intraocular surgery 5. Patient's doctor has determined they have a condition (i.e., UNCONTROLLED systemic disease) or are in a situation that may put them at significant risk, confound the study results or may interfere significantly with their participation in the study 6. Female patients who are pregnant, nursing an infant or planning a pregnancy 7. Patients who are currently involved in another investigational study or have participated in one within the 30 days prior to entering this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aqueous concentrations | 8 months |
Secondary
| Measure | Time frame |
|---|---|
| PGE2 Inhibition | 8 months |
Countries
United States
Outcome results
None listed