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

• Sponsor: Bp Consulting, Inc (Other)
• Overall Status: Completed
• CT.gov ID: NCT00622037
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 23.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: PEG-400 based artificial tear; Drug: Systane	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 PEG-400 based artificial tear	Drug: PEG-400 based artificial tear; Instill one drop in the randomized eye four times daily. Can be used more frequently if needed
Active Comparator: 2 Systane	Drug: Systane; Instill one drop in the randomized eye four times daily. Can be used more frequently if needed

Outcome Measures

Primary Outcome Measures

1. Dry Eye Signs [4 months]

Secondary Outcome Measures

1. Visual Quality [4 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Florida Microsurgical Eye Institute	Boynton Beach	Florida	United States	33426

Sponsors and Collaborators

• Bp Consulting, Inc

Investigators

• Principal Investigator: Barry Schechter, MD, Florida Microsurgical Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00622037
• Other Study ID Numbers: 5338
• First Posted: Feb 22, 2008
• Last Update Posted: Feb 3, 2010
• Last Verified: Feb 1, 2010

• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Lubricant Eye Drops

Study Results

No Results Posted as of Feb 3, 2010