The Clinical Comparison of Senofilcon A and Stenfilcon A Contact Lenses

Myopia Clinical Trial

Official title:

The Clinical Comparison of Senofilcon A and Stenfilcon A Contact Lenses

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02643004
• Other study ID #: EX-MKTG-62
• Status: Active, not recruiting
• Phase: Phase 4
• First received: December 28, 2015
• Last updated: May 19, 2016
• Start date: December 2015
• Est. completion date: June 2016

Study information

• Verified date: May 2016
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to compare the clinical performance of senofilcon A lens with the stenfilcon A lens each for one week of daily disposable wear.

Description:

The purpose of this bilateral cross-over study is to evaluate the clinical performance of senofilcon A lens with the stenfilcon A lens. In particular, the study will focus on ocular physiology, lens fit, lens surface, visual acuity, and subjective response.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria

Subjects will only be eligible for the study if:

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

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

• They are willing and able to follow the protocol.

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

• They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)

• They have a spectacle cylindrical correction of -0.75D or less in each eye.

• 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.

• They currently use soft contact lenses or have done so in the previous six months.

• They are willing to comply with the wear schedule (at least six days per week and for at least eight hours per day).

Exclusion criteria

Subjects will not be eligible to take part in the study 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 have had cataract surgery.

• They have had corneal refractive surgery.

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

• They are pregnant or lactating.

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

• 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.

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

• They currently wear either MyDay (daily) or the Acuvue Oasys (2 weekly) lens.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Senofilcon A
contact lens
• Stenfilcon A
contact lens

Locations

Country	Name	City	State
United Kingdom	Eurolens Research - The University of Manchester	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	Ocular Physiology, corneal staining - senofilcon A and stenfilcon A	Assessment of corneal staining is graded for five regions (central, superior, temporal, inferior and nasal) and assessed by biomicroscopy (Scale 0-4, 0= normal, 4=severe).; C - Central, N - Nasal, T - Temporal, S - Superior, I - Interior	Up to 1 week	No
Primary	Ocular Physiology, conjunctival and limbal redness - senofilcon A and stenfilcon A	Assessment of conjunctival and limbal redness is graded for five regions (central, superior, temporal, inferior and nasal) and assessed by biomicroscopy (Scale 0-4, 0= normal, 4=severe).; C - Central, N - Nasal, T - Temporal, S - Superior, I - Interior	Up to 1 week	No
Primary	Ocular Physiology, conjunctival staining - senofilcon A and stenfilcon A	Assessment of conjunctival staining is graded for five regions (central, superior, temporal, inferior and nasal) and assessed by biomicroscopy (Scale 0-4, 0= normal, 4=severe).; C - Central, N - Nasal, T - Temporal, S - Superior, I - Interior	Up to 1 week	No
Primary	Subjective response - overall - senofilcon A and stenfilcon A	Subjective responses will be evaluated for each pair using questionnaire and rated on subjective response scale for comfort (Scale 0-100, 0=extremely poor, 100=excellent)	Up to 1 week	No
Primary	Subjective response - comfort - senofilcon A and stenfilcon A	Subjective responses will be evaluated for each pair using questionnaire and rated on subjective response scale for comfort (Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).	Up to 1 week	No
Primary	Subjective response - dryness- senofilcon A and stenfilcon A	Subjective responses will be evaluated for each pair using questionnaire and rated on subjective response scale for comfort (Scale 0-100, 0=extremely poor, high levels of dryness, 100=excellent, no dryness).	Up to 1 week	No
Primary	Subjective response - vision - senofilcon A and stenfilcon A	Subjective responses will be evaluated for each pair using questionnaire and rated on subjective response scale for comfort (Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent).	Up to 1 week	No
Secondary	Lens fit, centration - senofilcon A	Lens fit will be assessed for senofilcon A at baseline using the following evaluations: horizontal and vertical centration, corneal coverage and movement.	Baseline	No
Secondary	Lens fit, centration - senofilcon A	Lens fit will be assessed for senofilcon A at 1 week using the following evaluations: horizontal and vertical centration, corneal coverage and movement.	1 week	No
Secondary	Lens fit, movement- senofilcon A	Lens fit will be assessed for senofilcon A at baseline using the following evaluations: horizontal and vertical centration, corneal coverage and movement.	Baseline	No
Secondary	Lens fit, movement- senofilcon A	Lens fit will be assessed for senofilcon A at 1 week using the following evaluations: horizontal and vertical centration, corneal coverage and movement.	1 week	No
Secondary	Lens fit, centration - stenfilcon A	Lens fit will be assessed for stenfilcon A at baseline using the following evaluations: horizontal and vertical centration, corneal coverage and movement.	Baseline	No
Secondary	Lens fit, centration - stenfilcon A	Lens fit will be assessed for stenfilcon A at 1 week using the following evaluations: horizontal and vertical centration, corneal coverage and movement.	1 week	No
Secondary	Lens fit, movement - stenfilcon A	Lens fit will be assessed for stenfilcon A at baseline using the following evaluations: horizontal and vertical centration, corneal coverage and movement.	Baseline	No
Secondary	Lens fit, movement - stenfilcon A	Lens fit will be assessed for stenfilcon A at 1 week using the following evaluations: horizontal and vertical centration, corneal coverage and movement.	1 week	No
Secondary	Lens Surface - senofilcon A	Lens surface for senofilcon A is assessed at baseline with evaluation of deposition type, deposition degree, debris, and wettability using grading scale.	Baseline	No
Secondary	Lens Surface - senofilcon A	Lens surface for senofilcon A is assessed at 1 week with evaluation of deposition type, deposition degree, debris, and wettability grading scale.	1 week	No
Secondary	Lens Surface - stenfilcon A	Lens surface for stenfilcon A is assessed at baseline with evaluation of deposition type, deposition degree, debris, and wettability grading scale.	baseline	No
Secondary	Lens Surface - stenfilcon A	Lens surface for stenfilcon A is assessed at 1 week with evaluation of deposition type, deposition degree, debris, and wettability grading scale.	1 week	No
Secondary	Visual Acuity - senofilcon A	Measurement of visual acuity for senofilcon A is assessed at baseline by using computerized logMAR VA chart.	baseline	No
Secondary	Visual Acuity - senofilcon A	Measurement of visual acuity for senofilcon A is assessed at 1 week by using computerized logMAR VA chart.	1 Week	No
Secondary	Visual Acuity - stenfilcon A	Measurement of visual acuity for stenfilcon A is assessed at 1 week by using computerized logMAR VA chart.	baseline	No
Secondary	Visual Acuity - stenfilcon A	Measurement of visual acuity for stenfilcon A is assessed at 1 week by using computerized logMAR VA chart.	1 Week	No