A Range of Contact Lenses and Care System Combinations

Contact Lens Solutions Clinical Trial

Official title:

A Range of Contact Lenses and Care System Combinations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03632083
• Other study ID #: C17-635 (EX-MKTG-95)
• Status: Completed
• Phase: N/A
• Start date: September 12, 2018
• Est. completion date: December 12, 2018

Study information

• Verified date: August 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to compare the short-term clinical response to all combinations of two lens types: fanfilcon A and comfilcon A with two care systems: Hy-Care and Lite. The primary variables of interest are short-term biomicroscopy signs. Other variables of interest include subjective response and visual performance.

Description:

Subjects were randomized to wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in the Hy-Care contact lens solution and Lite contact lens solution.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 12, 2018
• Est. primary completion date: October 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. They are of legal age (18) 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 can be satisfactorily fitted with the study lens for a period of approximately 2 hours.

6. They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with their habitual spectacles.

7. They currently wear daily disposable soft contact lenses or have done so in the previous six months.

8. They are willing to comply with the wear schedule (approximately 2 hours on two different days)

9. They own a wearable pair of spectacles and agree to bring these to study visits.

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 currently wear reusable soft contact lenses in both eyes.

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

5. They have had cataract surgery.

6. They have had corneal refractive surgery.

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

8. They are pregnant or breast-feeding.

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

10. They have Type 2 or greater corneal staining prior to lens application at Visit 1 or 2

11. They have corneal staining covering greater than 20% in any corneal region at Visit 1a or 2a

12. 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.

13. 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

• Contact Lens Solutions

Intervention

Device:
• Hy-Care Contact Lens Solution
Hy-Care Contact Lens Solution
• Lite Contact Lens Solution
Lite Contact Lens Solution
• fanfilcon A soft contact lens
fanfilcon A soft contact lens
• comfilcon A soft contact lens
comfilcon A soft contact lens

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	Biomicroscopy - Conjuctival Hyperaemia	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).	Baseline (before lens insertion)
Primary	Biomicroscopy - Conjuctival Hyperaemia	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).	2 hours
Primary	Biomicroscopy - Limbal Hyperaemia	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).	Baseline (before contact lens insertion)
Primary	Biomicroscopy - Limbal Hyperaemia	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).	2 hours
Primary	Biomicroscopy - Corneal Vascularisation	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).	Baseline (before lens insertion)
Primary	Biomicroscopy - Corneal Vascularisation	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).	2 hours
Primary	Biomicroscopy - Microcysts	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).	Baseline (before lens insertion)
Primary	Biomicroscopy - Microcysts	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).	2 hours
Primary	Biomicroscopy - Oedema	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).	Baseline (before lens insertion)
Primary	Biomicroscopy - Oedema	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).	2 hours
Primary	Biomicroscopy - Conjunctival Staining	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).	Baseline (before lens insertion)
Primary	Biomicroscopy - Conjunctival Staining	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).	2 hours
Primary	Biomicroscopy - Papillary Conjunctivitis	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).	Baseline (before lens insertion)
Primary	Biomicroscopy - Papillary Conjunctivitis	Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).	2 hours
Secondary	Comfort	Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt).	Baseline 5 minutes after lens insertion
Secondary	Comfort	Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt).	2 hours
Secondary	Dryness	Subjective ratings of dryness for each pair of lenses measured only at follow up (scale: 0-100; 0=Intolerable levels of dryness, 100=No sensation of dryness).	2 hours
Secondary	Overall Score	Subjective ratings of overall score for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall).	Baseline 5 minutes after lens insertion
Secondary	Overall Score	Subjective ratings of overall score for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall).	2 hours