A Comparison of Two Contact Lenses

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700752
• Other study ID #: CR-0728
• Status: Completed
• Phase: N/A
• First received: June 17, 2008
• Last updated: May 5, 2015
• Start date: May 2008
• Est. completion date: July 2008

Study information

• Verified date: May 2015
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study seeks to evaluate the clinical and subjective performance of two established soft contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. They are of legal age (18 years) and capacity to volunteer.

2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.

3. They are willing and able to follow the protocol.

4. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.

5. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.

6. They have a maximum of 1.00D of refractive astigmatism (i.e. = 1.00 DC).

7. They have successfully worn contact lenses within six months of starting the study.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.

2. They have a systemic disorder which would normally contra-indicate contact lens wear.

3. They are using any topical medication such as eye drops or ointment.

4. They are aphakic.

5. They have had corneal refractive surgery.

6. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.

7. They are pregnant or lactating.

8. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.

9. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).

10. They have diabetes.

11. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia
• Refractive Error
• Refractive Errors

Intervention

Device:
• senofilcon A
silicone hydrogel contact lens
• balafilcon A
silicone hydrogel contact lens

Locations

Country	Name	City	State
United States	Indiana University	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-reported Comfort at at the Manufacturer's Recommended Lens Replacement Timeframe of 2-weeks (Senofilcon A) or 4-weeks (Balafilcon A).	Subjective rating of overall comfort using a 0 through 5 scale. 0=n/a, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent. Scores from 2-week and 4-week visits were combined for final values.	after 4 weeks of lens wear	No