The Clinical Evaluation of Two Daily Disposable Contact Lenses

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762996
• Other study ID #: CR-0707
• Status: Completed
• Phase: N/A
• Start date: August 2007
• Est. completion date: October 2007

Study information

• Verified date: May 2015
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• etafilcon A
contact lens
• omafilcon A
contact lens

Locations

Country	Name	City	State
United Kingdom	Eurolens Research	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.	Eurolens Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Lens Comfort	A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.>0 = comfortable, <0 = uncomfortable	1 week