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Endothelial Bleb Response With Toric Lenses

This study has been completed.
Sponsor:
Information provided by:
Vistakon
ClinicalTrials.gov Identifier:
NCT00630305
First received: February 28, 2008
Last updated: August 19, 2008
Last verified: August 2008

February 28, 2008
August 19, 2008
January 2008
July 2008   (final data collection date for primary outcome measure)
Grade of percent of endothelial blebs in the following locations; Central, Nasal, Temporal, Inferior, Superior [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00630305 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Endothelial Bleb Response With Toric Lenses
Evaluation of the Short-Term Corneal Endothelial Response to Wear of Toric Soft Contact Lenses in Asian Eyes

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Vision Correction
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
July 2008
July 2008   (final data collection date for primary outcome measure)

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

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)
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00630305
CR-0726, JJO0717
No
Kurt Moody, OD, FAAO- Manager Clinical Research, Vistakon
Vistakon
Not Provided
Principal Investigator: Noel A Brennan, McOptom PhD Brennan Consultants
Vistakon
August 2008

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