Trials Sponsors Conditions Drugs Pricing

Conditions

Corneal Staining

Keywords

Corneal staining and comfort evaluation in normal, habitual contact lens wearers.

Outcome Measures

Primary Outcomes (1)

Corneal Staining by Wear Time
All participants were contact lenses wearers and were evaluated with a Corneal Staining at 1 hour, 2 hours, 4 hours and end of day. The corneal staining test is performed using fluorescein drops in the eye and ultraviolet illumination to determine if there has been any damage to the cornea from the use of the lens solutions or from the use of the contact lens.
1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4

Secondary Outcomes (2)

Subjective Solution Preference
Day 4
Overall Ocular Comfort
Day 4

Study Arms (2)

Biotrue MPS

ACTIVE COMPARATOR

Device: Biotrue MPS

Investigational MPS

EXPERIMENTAL

Device: Investigational MPS

Interventions

Biotrue MPSDevice

Multi-purpose contact lens care solution

Biotrue MPS

Investigational MPSDevice

Multi-purpose contact lens care solution

Investigational MPS

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

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

You may qualify if:

were at least 18 years old;
were experienced contact lens wearers;

Sponsors & Collaborators

Abbott Medical Optics
Industrylead

Study Sites (1)

Abbott Medical Optics Inc

Santa Ana, California, 92705, United States

Results Point of Contact

Title: Senior Manager, Clinical Research
Organization: Abbott Medical Optics

Study Officials

Eugenia Y Kao, OD
AMO
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

30 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: OTHER
Intervention Model: FACTORIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 8, 2010

First Posted

November 15, 2010

Study Start

August 31, 2010

Actual (reported)

Short-Term Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Biotrue MPS

Investigational MPS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

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

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Biotrue MPS

Investigational MPS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations