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Sponsored by: |
Vistakon |
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Information provided by: | Vistakon |
ClinicalTrials.gov Identifier: | NCT00630305 |
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 |
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Vision Correction |
Device: toric contact lenses |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Crossover Assignment |
Official Title: | Evaluation of the Short-Term Corneal Endothelial Response to Wear of Toric Soft Contact Lenses in Asian Eyes |
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 |
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3: Active Comparator
Control: lotrafilcon B toric
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Device: toric contact lenses
30 minutes of contact lens wear for each arm for two states; open eye and closed eye
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2: Active Comparator
Control: alphafilcon A toric
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Device: toric contact lenses
30 minutes of contact lens wear for each arm for two states; open eye and closed eye
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1: Experimental
Test: senofilcon A toric
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Device: toric contact lenses
30 minutes of contact lens wear for each arm for two states; open eye and closed eye
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Australia, Victoria | |
Brennan Consultants 110 Auburn Rd | |
Auburn Village, Victoria, Australia, 3122 |
Principal Investigator: | Noel A Brennan, McOptom PhD | Brennan Consultants |
Responsible Party: | Vistakon ( Kurt Moody, OD, FAAO- Manager Clinical Research ) |
Study ID Numbers: | CR-0726, JJO0717 |
Study First Received: | February 28, 2008 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00630305 |
Health Authority: | Australia: National Health and Medical Research Council |
toric endothelial bleb |
Blister |