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Study to Evaluate a Contact Lens Lubricating and Rewetting Drop

Primary Purpose

Dry Eye

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lubricating and Rewetting Drops
AMO Blink Contacts Lubricant Eye Drops
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Dry Eye focused on measuring rewetting, lubricating, eye drops

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Bausch & Lomb

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lubricating and Rewetting Drops

AMO Blink Contacts Lubricant Eye Drops

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 27, 2010
Last Updated
September 29, 2020
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01267656
Brief Title
Study to Evaluate a Contact Lens Lubricating and Rewetting Drop
Official Title
Study to Evaluate the Product Feasibility of a Contact Lens Lubricating and Rewetting Drop
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
rewetting, lubricating, eye drops

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lubricating and Rewetting Drops
Arm Type
Experimental
Arm Description
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.
Arm Title
AMO Blink Contacts Lubricant Eye Drops
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Lubricating and Rewetting Drops
Intervention Description
Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.
Intervention Type
Device
Intervention Name(s)
AMO Blink Contacts Lubricant Eye Drops
Intervention Description
Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.
Primary Outcome Measure Information:
Title
Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2.
Description
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.
Time Frame
At 1 week follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Su, OD
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bausch & Lomb
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States

12. IPD Sharing Statement

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Study to Evaluate a Contact Lens Lubricating and Rewetting Drop

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