Efficacy of PEG-400 and Systane Artificial Tears (Alcon) on Quality of Vision

Phase 4

Completed

• Conditions: Myopia
• Interventions: Drug: Systane; Drug: PEG-400

• Registration Number: NCT00627302
• Lead Sponsor: Bp Consulting, Inc

Brief Summary

To evaluate the effect of PEG-400 and Systane on quality of vision after LASIK.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-22
• Study First Submitted QC: 2008-02-29
• Study First Posted: 2008-03-03
• Status Verified: 2008-11
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Last Update Submitted: 2008-11-20
• Last Update Posted: 2008-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Males or females > 21 years old
• Scheduled to undergo bilateral LASIK
• Likely to complete all study visits and able to provide informed consent

Exclusion Criteria

• Prior or current use of topical cyclosporine within the last 1 year
• Known contraindications to any study medication or ingredients
• Ocular disorders
• Active ocular diseases or uncontrolled systemic disease
• Active ocular allergies
• Complications at the time of surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Systane	Systane
1	PEG-400	PEG-400

Primary Outcome Measures

Name	Time	Method
Quality of vision	5 months

Secondary Outcome Measures

Name	Time	Method
Efficacy	5 months

Trial Locations

Locations (1)

Ophthalmic Consultants of long Island; 🇺🇸 Rockville Centre, New York, United States