Clinical Evaluation of Two Daily Disposable Contact Lenses

NCT01163760 | Completed Results

• 2 other identifiers: CR-0706PRO-518
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to evaluate the clinical performance of two daily disposable contact lenses.

Conditions

Refractive Error

Outcome Measures

Primary Outcomes (1)

• Lens Comfort

  Lens comfort was evaluated via the subjective question: "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" (excellent/very good=5...very good=3...Poor=0)

  1-week follow-up

Secondary Outcomes (1)

• Comfort Throughout the Whole Day

  1-week follow-up

Other Outcomes (1)

• Comfort While Working on Computer

  1-week-follow-up

Study Arms (4)

etafilcon A / ocufilcon D

OTHER

etafilcon A contact lens worn first daily disposable , ocufilcon D contact lens worn second daily disposable

Device: etafilcon A; Device: ocufilcon D

oculfilcon D / etafilcon A

OTHER

ocufilcon D contact lens worn first, etafilcon A contact lens worn second

Device: etafilcon A; Device: ocufilcon D

ocufilcon D / ocufilcon D

OTHER

ocufilcon D contact lens worn first and second

Device: ocufilcon D

etafilcon A / etafilcon A

OTHER

etafilcon A contact lens worn first and second

Device: etafilcon A

Interventions

etafilcon A DEVICE

daily disposable contact lens

etafilcon A / etafilcon A; etafilcon A / ocufilcon D; oculfilcon D / etafilcon A

ocufilcon D DEVICE

daily disposable contact lens

etafilcon A / ocufilcon D; ocufilcon D / ocufilcon D; oculfilcon D / etafilcon A

Eligibility Criteria

• Age: 21 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be between 21 and 39 years of age.
• Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
• Be existing (i.e. successfully worn for 1-month prior to the study) soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
• Require a visual correction in both eyes (monovision allowed but no monofit).
• Have a contact lens spherical distance requirement between -1.00D and -6.00D in both eyes.
• Astigmatism of 1.00D or less in both eyes.
• Be able to wear the lens powers available for this study.
• Be correctable to a visual acuity of 20/30 or better in each eye.
• Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
• No amblyopia.
• No evidence of lid abnormality or infection.
• No conjunctival abnormality or infection.
• No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularisation, infiltrates or abnormal opacities).
• No other active ocular disease.

You may not qualify if:

• Requires concurrent ocular medication.
• Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
• Clinically significant (Grade 3 or 4) corneal edema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
• Diabetic.
• Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
• Extended lens wear in last 3 months.
• PMMA or RGP lens wear in the previous 8 weeks.
• Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
• Abnormal lacrimal secretions.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Keratoconus or other corneal irregularity.
• Pregnancy, lactating or planning a pregnancy at the time of enrollment.
• Participation in any concurrent clinical trial or in last 60 days."

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead
• Singapore Polytechnic University: collaborator
• Visioncare Research Ltd.: collaborator

Study Sites (1)

Unknown Facility

Singapore, Singapore

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Limitations and Caveats

The integrity of the subject reported data is suspect and not reflective of lens' performance due to a significant protocol deviation. Upon completion of the study it was found that subjects were unmasked and their data should be considered biased.

Results Point of Contact

• Title: Kurt Moody OD, FAAO
• Organization: Vistakon

904-443-3088

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2008
• First Posted: July 16, 2010
• Study Start: September 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: June 19, 2018
• Results First Posted: July 16, 2010

Record last verified: 2015-05

Locations

SG (1)