A Randomized Clinical Trial Comparing the Effect of Moxifloxacin Versus Gatifloxacin Following Pterygium Excision on Corneal Epithelial Healing and Epithelial Toxicity.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Meir Medical Center
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- rate of corneal epithelial defect closure
Study Overview
Brief Summary
The purpose of this study is to determine whether there is a difference in corneal epithelial healing rate and/or toxicity following pterygium excision, between eyes treated post-operatively by moxifloxacin(VIGAMOX)versus gatifloxacin (ZYMAR).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosis of primary pterygium with a clinical indication for surgery
- •informed consent
Exclusion Criteria
- •known allergic reaction to fluoroquinolones.
- •secondary\recurrent pterygium or clinical suspected conjunctival tumor.
- •eye surgery in the last 6 months.
- •eye disorders: severe dry eye syndrome, ocular surface diseases, glaucoma, recurrent corneal erosions, chronic corneal diseases, after chemical burn.
- •low compliance.
Arms & Interventions
Moxifloxacin
About 20 patients treated by Moxifloxacin ophthalmic solution 0.5% (Vigamox) 4 times a day (one drop each time) after pterygium excision with Mitomycin C application.
Intervention: Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3% (Drug)
Gatifloxacin
About 20 patients treated by Gatifloxacin ophthalmic solution 0.3% (Zymar) 4 times a day (one drop each time) after pterygium excision with Mitomycin C application.
Intervention: Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3% (Drug)
Outcomes
Primary Outcomes
rate of corneal epithelial defect closure
Time Frame: 21 days
Secondary Outcomes
- toxicity findings: punctate keratitis, inferior conjunctival hyperemia, conjunctival papillary reaction(12 days)