Evaluation of the Performance of Non-molded Soft Contact Lenses

NCT00371787 — Phase 3, Completed, 38 participants, University of Waterloo

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Registry	NCT00371787
Status	Completed
Phase	Phase 3
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	38 (Actual)
Sponsor	University of Waterloo (Other); collaborators: CIBA VISION
Conditions	Ametropia
Interventions	Soft contact lens (Device)
Dates	start 2006-08-01, primary completion 2007-12-01, completion 2007-12-01, first posted 2006-09-04, last updated 2011-01-10
Locations	1 site in Canada

-Summary

To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties.

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+Detailed description

To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties in a group of participants who present with lens related changes.

+Arms and interventions

Arm	Type	Interventions	Description
soft contact lens	Experimental	Device: Soft contact lens
non-lens wear	No intervention		control group

Soft contact lens (Device), also known as Custom O2Optix: Soft contact lens

+Outcome measures

Primary outcomes

Visual Acuity [baseline]: level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.
Visual Acuity [9 month]: level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.
Neovascularisation [baseline]: length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
Neovascularization [9 month]: length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.

+Eligibility

Sex: All, ages: 17 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Male or female, good health, age >17yrs, able to wear contact lenses as primary vision correction, able to see well and achieve good fit with study lens, has understood \& signed consent form.

Exclusion Criteria:

* Has active ocular disease, uses topical eye medication, wears gas permeable/silicone hydrogel /overnight wear contact lenses, is a participant in another clinical study, is deemed unsuitable for soft contact lens wear.

+Posted results

Participant flow

Milestone	Treatment Group	Control Group
Started	26	12
Completed	23	11
Not completed	3	1

Outcome results

Visual Acuity (Primary), Mean, logMAR: Treatment Group 0.01 +/- 0.09; Control Group -0.07 +/- 0.11
Visual Acuity (Primary), Mean, logMAR: Treatment Group 0.01 +/- 0.09; Control Group -0.08 +/- 0.10
Neovascularisation (Primary), Mean, mm: Treatment Group 0.84 +/- 0.39; Control Group 0.35 +/- 0.16
Neovascularization (Primary), Mean, mm: Treatment Group 0.63 +/- 0.2; Control Group 0.35 +/- 0.19

Adverse events

Arm	Deaths	Serious adverse events	Other adverse events
Treatment Group	0	0/26 (0.0%)	0/26 (0.0%)
Control Group	0	0/12 (0.0%)	0/12 (0.0%)

+Locations (1)

Facility	City	Country	Status
Centre for Contact Lens Research, University of Waterloo,	Waterloo, Ontario	Canada

+Investigators

Desmond Fonn, Principal investigator, Centre for Contact Lens Research