The Clinical Performance of the Biofinity Contact Lens (Comfilcon A) With Two Lens Care Systems

Myopia Clinical Trial

Official title:

The Clinical Performance of the Biofinity Contact Lens (Comfilcon A) With Two Lens Care Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02510820
• Other study ID #: EX-MKTG-54
• Status: Completed
• Phase: N/A
• First received: July 16, 2015
• Last updated: January 30, 2017
• Start date: May 2015
• Est. completion date: October 2015

Study information

• Verified date: January 2017
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a controlled and randomized, single-masked, crossover study in which 48 subjects will use the Biofinity Contact Lens (comfilcon A) with each of the two lens care products ('solutions'), (Synergi and Biotrue Multi-purpose Solution) for one month each. Follow-up visits for each solution will take place at one week, two weeks and four weeks: with a one-week 'wash-out' period between the solutions. Key outcome measures for this study include biomicroscopic and subjective responses to the lens/solution combinations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. They are of legal age and capacity to volunteer.

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

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

4. They agree not to participate in other clinical research for the duration of this study.

5. They have a contact lens spherical prescription between - 0.50 to - 6.00 (inclusive)

6. They have a spectacle cylindrical correction of -1.00D (Diopters) or less in each eye.

7. At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.

8. They currently use silicone hydrogel soft contact lenses.

9. They are willing to comply with the wear schedule (at least 5 days per week, =8 hours/day).

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 have had cataract surgery.

5. They have had corneal refractive surgery.

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

7. They are pregnant or lactating.

8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.

9. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.

10. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• comfilcon A
soft contact lens
• Synergi
Multipurpose solution
• Biotrue
Multipurpose solution

Other:
• stenfilcon A
daily disposable contact lenses for washout period

Locations

Country	Name	City	State
United Kingdom	Eurolens Research	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conjunctival Hyperaemia	Conjunctival hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.	Baseline, 1 week, 2 weeks, 4 weeks
Primary	Limbal Hyperaemia	Limbal hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.	Baseline, 1 week, 2 weeks, 4 weeks
Primary	Corneal Staining	Corneal staining of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=none, 4=patch.	Baseline, 1 week, 2 weeks, 4 weeks
Primary	Papillary Conjunctivitis	Papillary conjunctivitis of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.	Baseline, 1 week, 2 weeks, 4 weeks
Primary	Comfort	Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 1 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.	1 week
Primary	Comfort	Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 2 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.	2 weeks
Primary	Comfort	Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 4 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.	4 weeks
Primary	Vision	Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.	1 week
Primary	Vision	Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 2 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.	2 weeks
Primary	Vision	Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 4 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.	4 weeks
Primary	Dryness	Subjective assessment of dryness for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=extremely dry 100=not dry at all.	1 week, 2 weeks, 4 weeks
Primary	Burning/Stinging	Subjective assessment of burning/stinging for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=Extreme stinging / burning, 100=No stinging / burning sensation.	1 week, 2 weeks, 4 weeks
Primary	Ocular Redness	Subjective ocular redness of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=extremely poor. intolerable levels of redness, 100=excellent, no redness.	1 week, 2 weeks, 4 weeks
Primary	Ease of Lens Insertion	Subjective assessment of insertionfor Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to insert, 100=excellent. no problem with lens insertion.	1 week, 2 weeks, 4 weeks
Primary	Ease of Lens Removal	Subjective assessment of removal for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to remove, 100=excellent. no problem with lens remove.	1 week, 2 weeks, 4 weeks
Primary	Ease of Use of Solution	Subjective ease of use for Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=very difficult, 100=very easy	1 week, 2 weeks, 4 weeks
Primary	Overall Score	Subjective overall scores Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=extremely poor, 100=excellent, highly impressed.	1 week, 2 weeks, 4 weeks