Bilateral, Masked Comparison of PEG-400 Based Artificial Tear and Systane for the Treatment of Dry Eye Signs, Symptoms and Visual Quality

Phase 4

Completed

• Conditions: Dry Eye
• Interventions: Drug: PEG-400 based artificial tear; Drug: Systane

• Registration Number: NCT00622037
• Lead Sponsor: Bp Consulting, Inc

Brief Summary

To evaluate and compare the effects of PEG-400 based artificial tear and Systane tears in mild-moderate dry eye patients. TBUT, Visual impact and subjective evaluations will be assessed in this month long trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-13
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-22
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-02
• Last Update Posted: 2010-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patient reported dry eye symptoms (episodic, annoying, activity limiting), SES OD.
• Physician assessment of mild-moderate dry eye
• Patient willing to instill drops QID and complete entire length of protocol.
• TBUT < 10 seconds
• BCVA of 20/30 or better

Exclusion Criteria

• Current topical cyclosporine use (Restasis)
• Current Systane use
• Refractive surgery within the last 6 months
• Oral or topical corticosteroid use
• Severe dry eye patients by physician assessment
• current active Blepharitis
• Oral Doxycyclines use
• Oral Antihistamine use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	PEG-400 based artificial tear	PEG-400 based artificial tear
2	Systane	Systane

Primary Outcome Measures

Name	Time	Method
Dry Eye Signs	4 months

Secondary Outcome Measures

Name	Time	Method
Visual Quality	4 months

Trial Locations

Locations (1)

Florida Microsurgical Eye Institute; 🇺🇸 Boynton Beach, Florida, United States