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

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627302
• Other study ID #: 5353
• Status: Completed
• Phase: Phase 4
• First received: February 22, 2008
• Last updated: November 20, 2008
• Start date: February 2008
• Est. completion date: November 2008

Study information

• Verified date: November 2008
• Source: Bp Consulting, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• PEG-400
Day of Surgery: Starting 2 hours after surgery Instill one drop in randomized eye every two hours. Day 1-Week 1: Instill one drop in randomized eye four times daily
• Systane
Day of Surgery: Starting 2 hours after surgery Instill one drop in randomized eye every two hours. Day 1-Week 1: Instill one drop in randomized eye four times daily

Locations

Country	Name	City	State
United States	Ophthalmic Consultants of long Island	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bp Consulting, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of vision		5 months	No
Secondary	Efficacy		5 months	No