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

Bp Consulting

Status and phase: Completed; Phase 4

Conditions: Dry Eye

Treatments: Drug: PEG-400 based artificial tear; Drug: Systane

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00622037

5338

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

1

Active Comparator group

Description:

PEG-400 based artificial tear

Treatment:

Drug: PEG-400 based artificial tear

2

Active Comparator group

Description:

Systane

Treatment:

Drug: Systane