Effect of Moxifloxacin Versus Gatifloxacin on Corneal Epithelium Following Pterygium Excision

Clalit Health Services

Status: Unknown

Conditions: Primary Pterygium

Treatments: Drug: Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3%

Study type: Interventional

Funder types: Other

Identifiers

NCT00892918

PVZ-001

Details and patient eligibility

About

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. diagnosis of primary pterygium with a clinical indication for surgery
2. informed consent

Exclusion criteria

1. known allergic reaction to fluoroquinolones.
2. secondary\recurrent pterygium or clinical suspected conjunctival tumor.
3. eye surgery in the last 6 months.
4. eye disorders: severe dry eye syndrome, ocular surface diseases, glaucoma, recurrent corneal erosions, chronic corneal diseases, after chemical burn.
5. low compliance.
6. pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Moxifloxacin

Active Comparator group

Description:

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.

Treatment:

Drug: Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3%

Gatifloxacin

Active Comparator group

Description:

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.

Treatment:

Drug: Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3%