Masked Comparison of a New PEG Based Artificial Tear and Optive for Comfort, Vision & Wear Time in Patients Wearing Contact Lenses

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Status and phase: Completed; Phase 4

Conditions: Comfort, Vision and Wear Time

Treatments: Drug: New PEG based artificial tear; Drug: Optive

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00570843

0710009485

Details and patient eligibility

About

The objective of this study is to evaluate the effect of a new PEG based artificial tear as compared to Optive on comfort, wear time, and vision in patients wearing contact lenses.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Use of soft contact lenses (e.g. silicone hydrogel lenses, daily disposables etc.) and multipurpose solution for cleaning, including enzyme-based cleaners (ClearCare etc.)
• Able to wear contact lenses for approximately 10-12 hours/day
• Willingness to complete entire length of trial and comply with subjective questionnaire.

Exclusion criteria

• Patients taking topical cyclosporine (Restasis)
• Patients currently using Optive for dryness relief.
• Patients wearing hard or rigid gas permeable lenses
• Patients with uncontrolled systemic disease which may confound the results of the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

1.

Active Comparator group

Treatment:

Drug: New PEG based artificial tear

2.

Placebo Comparator group

Treatment:

Drug: Optive