Trials Sponsors Conditions Drugs Pricing

Conditions

Study Focus is Healthy Contact Lens Wearers

Keywords

adapted contact lens wearers

Outcome Measures

Primary Outcomes (1)

Mean Lens Cleanliness as Measured by Light Reflectance
Lens cleanliness was assessed by total light reflectance, which is a computerized quantitative assessment conducted in a laboratory. The amount of light that scattered off the lens surface in a light field and was assessed using a light reflectance score that ranged from 0 (maximum lens cleanliness; clean/clear) to100 (minimum lens cleanliness; dirty/opaque).
Day 30

Secondary Outcomes (1)

Number of Subjects With no Corneal Staining
Day 180

Study Arms (2)

Investigational MPS

EXPERIMENTAL

Investigational multipurpose disinfecting solution (study MPS)

Device: Investigational MPS

Predicate MPS

ACTIVE COMPARATOR

Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)

Device: Opti-Free

Interventions

Investigational MPSDevice

Multi-purpose solution

Also known as: Cobra

Investigational MPS

Opti-FreeDevice

Multi-purpose solution

Also known as: RepleniSH

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Have successfully worn hydrogel contact lenses of the same material to be worn during the study
Have normal eyes (with the exception of unaided visual acuity)

Sponsors & Collaborators

Abbott Medical Optics
Industrylead

Study Sites (9)

Complete Family Vision Center

San Diego, California, 92123, United States

Eye Care Associates of Hawaii

Waipahu, Hawaii, 96797, United States

Insight Eyecare

Warrensburg, Missouri, 64093, United States

Drs. Quinn, Quinn & Associates

Athens, Ohio, 45701, United States

Western Reserve Vision Care

Beachwood, Ohio, 44122, United States

Central Ohio Eyecare

Columbus, Ohio, 43202, United States

Northeastern Eye Institute

Scranton, Pennsylvania, 18503, United States

Results Point of Contact

Title: Eugenia Thomas, O.D.
Organization: Abbott Medical Optics

Study Officials

Nicholas Tarantino, OD
Abbott Medical Optics
STUDY CHAIR

Publication Agreements

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

Enrollment

270 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 27, 2009

First Posted

August 18, 2009

Study Start

February 2009

Date type not reported

This date has not been verified as actual or estimated.

Evaluation of an Investigational Multi-Purpose Solution (MPS)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

Primary Completion

First Posted

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Investigational MPS

Predicate MPS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

Primary Completion

First Posted

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Investigational MPS

Predicate MPS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations