Endothelial Bleb Response With Toric Lenses

Tracking Information
First Submitted Date ICMJE	February 28, 2008
First Posted Date ICMJE	March 7, 2008
Results First Submitted Date	March 26, 2014
Results First Posted Date	March 3, 2017
Last Update Posted Date	March 3, 2017
Study Start Date ICMJE	January 2008
Actual Primary Completion Date	July 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 11, 2017)	Endothelial Bleb Areas on Cornea: Session A- Open Eye [ Time Frame: 20 minutes post-lens insertion ]Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.; Endothelial Bleb Areas on Cornea: Session B- Closed Eye [ Time Frame: 20 minutes post-lens insertion ]Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.; Endothelial Bleb Areas on Cornea: Session C- Open Eye [ Time Frame: 20 minutes post-lens insertion ]Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.; Endothelial Bleb Areas on Cornea: Session D- Closed Eye [ Time Frame: 20 minutes post-lens insertion ]Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.
Original Primary Outcome Measures ICMJE; (submitted: February 28, 2008)	Grade of percent of endothelial blebs in the following locations; Central, Nasal, Temporal, Inferior, Superior [ Time Frame: 20 minutes ]
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 open eye and closed eye state.
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 Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Treatment
Condition ICMJE	Ametropia
Intervention ICMJE	Device: alphafilcon A toric Subjects that were randomized to receive alphafilcon A toric during one of the four sessions (Sessions A, B, C and D).; Device: lotrafilcon B toric Subjects that were randomized to receive lotrafilcon B toric during one of the four sessions (Sessions A, B, C and D).; Device: senofilcon A toric Subjects that were randomized to receive senofilcon A toric during one of the four sessions (Sessions A, B, C and D).
Study Arms	Session A Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session A only contains senofilcon A toric and alphafilcon A toric lenses. Interventions: Device: alphafilcon A toric Device: senofilcon A toric; Session B Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session B only contains senofilcon A toric and alphafilcon A toric lenses. Interventions: Device: alphafilcon A toric Device: senofilcon A toric; Session C Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session C only contains senofilcon A toric and lotrafilcon B toric lenses. Interventions: Device: lotrafilcon B toric Device: senofilcon A toric; Session D Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session D only contains senofilcon A toric and lotrafilcon B toric lenses. Interventions: Device: lotrafilcon B toric Device: senofilcon A toric
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
Actual Enrollment ICMJE; (submitted: August 19, 2008)	37
Original Estimated Enrollment ICMJE; (submitted: February 28, 2008)	35
Actual Study Completion Date	July 2008
Actual 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)
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 50 Years (Adult)
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	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Johnson & Johnson Vision Care, Inc.
Study Sponsor ICMJE	Johnson & Johnson Vision Care, Inc.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Noel A Brennan, McOptom PhD Brennan Consultants
PRS Account	Johnson & Johnson Vision Care, Inc.
Verification Date	January 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP