Endothelial Bleb Response With Toric Lenses

This study has been completed.

Sponsor:

Information provided by:

Johnson & Johnson Vision Care, Inc.

ClinicalTrials.gov Identifier:

NCT00630305

First received: February 28, 2008

Last updated: August 19, 2008

Last verified: August 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

February 28, 2008

Last Updated Date

August 19, 2008

Start Date ^ICMJE

January 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Grade of percent of endothelial blebs in the following locations; Central, Nasal, Temporal, Inferior, Superior [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00630305 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Endothelial Bleb Response With Toric Lenses

Official Title ^ICMJE

Evaluation of the Short-Term Corneal Endothelial Response to Wear of Toric Soft Contact Lenses in Asian Eyes

Brief Summary

Evaluate the short-term corneal response of oxygen deprivation when using toric contact lenses. The response will be noted by endothelial bleb formation in both and open eye and closed eye state. Hypotheses: senfilcon A toric will have at least as low endothelial bleb formation as two other toric lenses in both the open/closed eye states.

Detailed Description

Interested subjects who meet the entry criteria for the study will be scheduled for four sessions of approximately 30 minutes duration each. Informed consent obtained. Baseline measurements of visual acuity and corneal and conjunctival physiology will be recorded. An examination of the endothelium of the corneas will be conducted using the specular microscope, readings obtained at 5 locations on each cornea: one in the centre and one in each of the superior, inferior, nasal and temporal peripheral regions, approximately 2mm from the limbal margin. The assigned lenses will be inserted according to a fixed-allocation randomization schedule, where each session follows an optimized 2- period simultaneous crossover design, which specifies lenses to be used in each of the four sessions. Lenses will be worn for 20 minutes and then removed. Endothelial specular microscopy will be conducted at 20 minutes with the lenses on. A final evaluation of corneal and conjunctival physiology will be performed prior to subject clearance from the study.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Vision Correction

Intervention ^ICMJE

Device: toric contact lenses
30 minutes of contact lens wear for each arm for two states; open eye and closed eye

Other Name: SofLens toric
Device: toric contact lenses
30 minutes of contact lens wear for each arm for two states; open eye and closed eye

Other Name: O2Optix toric
Device: toric contact lenses
30 minutes of contact lens wear for each arm for two states; open eye and closed eye

Other Name: ACUVUE OASYS

Study Arm (s)

Active Comparator: 3
Control: lotrafilcon B toric

Intervention: Device: toric contact lenses
Active Comparator: 2
Control: alphafilcon A toric

Intervention: Device: toric contact lenses
Experimental: 1
Test: senofilcon A toric

Intervention: Device: toric contact lenses

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Successful soft contact lens wear in daily mode for a minimum of 1 month prior to start of the study without experiencing difficulties or contact lens related complications.
At least 18 years of age and mentally competent to sign an informed consent form.
Healthy eyes and no use of ocular medication.
Similarity of optical parameters between eyes.
Physical appearance typical of Asian eyes

Exclusion Criteria:

A medical or ocular condition that may influence the outcome of this trial.
Current use of ocular/systemic medication that may influence the outcome of this trial.
Failure to wear soft lenses for 2 weeks prior to the start of the study.
Current enrolment or participation in another clinical study.
Current state of pregnancy or breastfeeding
Anisometropia greater than 1.00D (equivalent sphere).
Unequal acuities between eyes (greater than 1 line)
Unequal corneal curvatures (>1.00D)

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Australia

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00630305

Other Study ID Numbers ^ICMJE

CR-0726, JJO0717

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Kurt Moody, OD, FAAO- Manager Clinical Research, Vistakon

Study Sponsor ^ICMJE

Johnson & Johnson Vision Care, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Noel A Brennan, McOptom PhD

Brennan Consultants

Information Provided By

Johnson & Johnson Vision Care, Inc.

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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