The Clinical Evaluation of Two Daily Disposable Contact Lenses

NCT00762996 | Completed Results

• 1 other identifier: CR-0707
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Distance Visual Acuity

  logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.

  1 week

Secondary Outcomes (1)

• Lens Comfort

  1 week

Study Arms (4)

etafilcon A/etafilcon A

ACTIVE COMPARATOR

Period 1: etafilcon A, Period 2: etafilcon A

Device: etafilcon A

etafilcon A/omafilcon A

ACTIVE COMPARATOR

Period 1: etafilcon A, Period 2: omafilcon A

Device: etafilcon A; Device: omafilcon A

omafilcon A/etafilcon A

ACTIVE COMPARATOR

Period 1: omafilcon A, Period 2: etafilcon A

Device: etafilcon A; Device: omafilcon A

omafilcon A/omafilcon A

ACTIVE COMPARATOR

Period 1: omafilcon A, Period 2: omafilcon A

Device: omafilcon A

Interventions

etafilcon A DEVICE

contact lens

etafilcon A/etafilcon A; etafilcon A/omafilcon A; omafilcon A/etafilcon A

omafilcon A DEVICE

contact lens

etafilcon A/omafilcon A; omafilcon A/etafilcon A; omafilcon A/omafilcon A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• They are of legal age (18 years) and capacity to volunteer.
• They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
• They are willing and able to follow the protocol.
• They would be expected to attain at least 6.9 (20/30) in each eye with the study lenses.
• They are able to wear contact lenses which have a back vertex power of -1.00 to -6.00DS.
• They have a maximum of 1.00D of refractive astigmatism (i.e. \< 1.00 DC).
• They have worn soft contact lenses within six months of starting the study.

You may not qualify if:

• They have an ocular disorder which would normally contra-indicate contact lens wear.
• They have a systemic disorder which would normally contra-indicate contact lens wear.
• They are using any topical medication such as eye drops or ointment.
• They are aphakic.
• They have had corneal refractive surgery.
• They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
• They are pregnant or lactating.
• They have grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
• They have any infectious disease (e.g., hepatitis) or any immunosuppressive disease (e.g., HIV).
• They have diabetes.
• They are currently taking part in any other clinical study or research.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead
• Eurolens Research: collaborator

Study Sites (1)

Eurolens Research

Manchester, M60 1QD, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

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 26, 2008
• First Posted: September 30, 2008
• Study Start: August 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: June 19, 2018
• Results First Posted: June 23, 2009

Record last verified: 2015-05

Locations

GB (1)