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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00630305
Registration number
NCT00630305
Ethics application status
Date submitted
28/02/2008
Date registered
7/03/2008
Date last updated
3/03/2017
Titles & IDs
Public title
Endothelial Bleb Response With Toric Lenses
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Scientific title
Evaluation of the Short-Term Corneal Endothelial Response to Wear of Toric Soft Contact Lenses in Asian Eyes
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Secondary ID [1]
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JJO0717
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Secondary ID [2]
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CR-0726
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ametropia
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - alphafilcon A toric
Treatment: Devices - lotrafilcon B toric
Treatment: Devices - senofilcon A toric
Other: 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.
Other: 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.
Other: 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.
Other: 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.
Treatment: Devices: alphafilcon A toric
Subjects that were randomized to receive alphafilcon A toric during one of the four sessions (Sessions A, B, C and D).
Treatment: Devices: lotrafilcon B toric
Subjects that were randomized to receive lotrafilcon B toric during one of the four sessions (Sessions A, B, C and D).
Treatment: Devices: senofilcon A toric
Subjects that were randomized to receive senofilcon A toric during one of the four sessions (Sessions A, B, C and D).
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Endothelial Bleb Areas on Cornea: Session A- Open Eye
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Assessment method [1]
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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.
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Timepoint [1]
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20 minutes post-lens insertion
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Primary outcome [2]
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Endothelial Bleb Areas on Cornea: Session B- Closed Eye
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Assessment method [2]
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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.
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Timepoint [2]
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20 minutes post-lens insertion
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Primary outcome [3]
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Endothelial Bleb Areas on Cornea: Session C- Open Eye
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Assessment method [3]
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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.
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Timepoint [3]
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20 minutes post-lens insertion
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Primary outcome [4]
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Endothelial Bleb Areas on Cornea: Session D- Closed Eye
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Assessment method [4]
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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.
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Timepoint [4]
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20 minutes post-lens insertion
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Eligibility
Key inclusion criteria
1. 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.
2. At least 18 years of age and mentally competent to sign an informed consent form.
3. Healthy eyes and no use of ocular medication.
4. Similarity of optical parameters between eyes.
5. Physical appearance typical of Asian eyes
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. A medical or ocular condition that may influence the outcome of this trial.
2. Current use of ocular/systemic medication that may influence the outcome of this
trial.
3. Failure to wear soft lenses for 2 weeks prior to the start of the study.
4. Current enrolment or participation in another clinical study.
5. Current state of pregnancy or breastfeeding
6. Anisometropia greater than 1.00D (equivalent sphere).
7. Unequal acuities between eyes (greater than 1 line)
8. Unequal corneal curvatures (>1.00D)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2008
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Sample size
Target
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Accrual to date
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Final
37
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Brennan Consultants 110 Auburn Rd - Auburn Village
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Recruitment postcode(s) [1]
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3122 - Auburn Village
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Johnson & Johnson Vision Care, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00630305
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Noel A Brennan, McOptom PhD
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Address
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Brennan Consultants
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00630305
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