Study to Evaluate a Contact Lens Lubricating and Rewetting Drop

NCT01267656 | Completed Results

• 1 other identifier: 684E
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye

Keywords

rewetting; lubricating; eye drops

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lubricating and Rewetting Drops

EXPERIMENTAL

Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week.

Device: Lubricating and Rewetting Drops

AMO Blink Contacts Lubricant Eye Drops

ACTIVE COMPARATOR

AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week

Device: AMO Blink Contacts Lubricant Eye Drops

Interventions

Lubricating and Rewetting Drops DEVICE

Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.

Lubricating and Rewetting Drops

AMO Blink Contacts Lubricant Eye Drops DEVICE

Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.

AMO Blink Contacts Lubricant Eye Drops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Study Director
• Organization: Bausch Health

susan.harris@bauschhealth.com

Study Officials

• Stephanie Su, OD

  Bausch & Lomb Incorporated

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2010
• First Posted: December 28, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 30, 2020
• Results First Posted: September 30, 2020

Record last verified: 2020-09

Locations

US (1)