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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
History of Changes
  Purpose

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.


Condition Intervention
Vision Correction
 Device: toric contact lenses

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of the Short-Term Corneal Endothelial Response to Wear of Toric Soft Contact Lenses in Asian Eyes

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Vistakon:

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

Enrollment: 37
Study Start Date: January 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 3
Control: lotrafilcon B 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
Active Comparator: 2
Control: alphafilcon A toric
 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
Experimental: 1
Test: senofilcon A 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00630305

Locations
Australia, Victoria
Brennan Consultants 110 Auburn Rd
Auburn Village, Victoria, Australia, 3122
Sponsors and Collaborators
Vistakon
Investigators
Principal Investigator: Noel A Brennan, McOptom PhD Brennan Consultants
  More Information

No publications provided

Responsible Party: Kurt Moody, OD, FAAO- Manager Clinical Research, Vistakon
ClinicalTrials.gov Identifier: NCT00630305     History of Changes
Other Study ID Numbers: CR-0726, JJO0717
Study First Received: February 28, 2008
Last Updated: August 19, 2008
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Vistakon:
toric
endothelial bleb

ClinicalTrials.gov processed this record on May 23, 2013