Study to Evaluate a Contact Lens Lubricating and Rewetting Drop

Dry Eye Clinical Trial

Official title:

Study to Evaluate the Product Feasibility of a Contact Lens Lubricating and Rewetting Drop

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267656
• Other study ID #: 684E
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: December 2010

Study information

• Verified date: September 2020
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the product performance of investigational lubricating and rewetting drops.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.

• Adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.

• Use a lens care system on a regular basis.

• Wear their habitual lenses (or be willing to wear lenses) a minimum of 8 hours per day.

• Willing to use drops 4 times per day.

Exclusion Criteria:

• Participating in a conflicting study.

• An active ocular disease, any corneal infiltrative response, or are using any ocular medications.

• Any scar or neovascularization within the central 4mm of the cornea.

• Any grade 2 or greater finding during the slit lamp examination

• Using any systemic or topical medications that will affect ocular physiology or lens performance.

• Aphakic.

• Amblyopic.

• Allergic to any component in the study care products.

• Have had any corneal surgery.

Related Conditions & MeSH terms

• Dry Eye

Intervention

Device:
• Lubricating and Rewetting Drops
Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.
• AMO Blink Contacts Lubricant Eye Drops
Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.

Locations

Country	Name	City	State
United States	Bausch & Lomb	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2.	Slit lamp findings for epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded 0 to 4, with 0 = none to 4 = severe. The outcome measure is any finding > grade 2, across abnormalities.	At 1 week follow up