A Clinical Performance of Two Soft Toric Contact Lenses

Astigmatism Clinical Trial

Official title:

A Clinical Performance of Two Soft Toric Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05633082
• Other study ID #: EX-MKTG-143
• Status: Completed
• Phase: N/A
• Start date: September 21, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study objective was to gather short-term clinical performance data for two soft toric contact lenses.

Description:

This participant-masked, non-randomized, controlled non-dispensing study was to compare the performance of two soft toric lenses. Participants attended one study visit which lasted for approximately 1.5 hours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 currently wear soft contact lenses, or have done so within the past two years.

• They have ocular astigmatism in both eyes of between 0.75DC and 3.00DC.

• They are expected to be able to be fitted with the study lenses within the power range available.

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 have keratoconus.

• They are pregnant or lactating.

• They have an eye or health condition including an immunosuppressive or infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.

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

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• Lens 1 (omafilcon B)
Toric daily wear contact lens for 15 minutes
• Lens 2 (fanfilcon A)
Toric daily wear contact lens for 15 minutes

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	Subjective Overall Score	The subjective overall impression of the contact lens (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Extremely poor, 100=Excellent.	15 minutes
Secondary	Subjective Comfort	Subjective comfort (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Causes pain,100=Excellent.	15 minutes
Secondary	Subjective Vision	Subjective vision (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Unacceptable,100=Excellent.	15 minutes