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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Evaluation of the Short-Term Corneal Endothelial Response to Wear of Toric Soft Contact Lenses in Asian Eyes
Secondary ID [1] 0 0
JJO0717
Secondary ID [2] 0 0
CR-0726
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ametropia 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Endothelial Bleb Areas on Cornea: Session A- Open Eye
Timepoint [1] 0 0
20 minutes post-lens insertion
Primary outcome [2] 0 0
Endothelial Bleb Areas on Cornea: Session B- Closed Eye
Timepoint [2] 0 0
20 minutes post-lens insertion
Primary outcome [3] 0 0
Endothelial Bleb Areas on Cornea: Session C- Open Eye
Timepoint [3] 0 0
20 minutes post-lens insertion
Primary outcome [4] 0 0
Endothelial Bleb Areas on Cornea: Session D- Closed Eye
Timepoint [4] 0 0
20 minutes post-lens insertion

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
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2008
Sample size
Target
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Brennan Consultants 110 Auburn Rd - Auburn Village
Recruitment postcode(s) [1] 0 0
3122 - Auburn Village

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Johnson & Johnson Vision Care, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Noel A Brennan, McOptom PhD
Address 0 0
Brennan Consultants
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00630305