Performance of Toric Silicone Hydrogel Contact Lenses

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05097144
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.5
• Patients Per Site Per Month: 6.6

Study Details

Study Description

Brief Summary

This is a prospective, randomized, double masked, (investigator and participant), bilateral, 1 month cross-over study comparing the handling characteristics, (insertion & removal), of control toric lenses against test silicone hydrogel toric lenses.

Condition or Disease	Intervention/Treatment	Phase
Astigmatism; Myopia	Device: Lens A (Test); Device: Lens B (control)	N/A

Detailed Description

Subjects will be randomized to wear control toric lenses against test silicone hydrogel toric lenses for one month to compare lens handling.

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Performance of Two Toric Silicone Hydrogel Contact Lenses
• Actual Study Start Date: Aug 21, 2021
• Actual Primary Completion Date: Dec 30, 2021
• Actual Study Completion Date: Feb 4, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lens A (Test) Subjects will be randomized to wear test lenses (Lens A) for one month and then cross-over to wear to control lens B for one month.	Device: Lens A (Test); Test toric lens A; Device: Lens B (control); Control toric lens B
Active Comparator: Lens B (Control) Subjects will be randomized to wear control lenses (Lens B) for one month and then cross-over to wear Test lens A for one month.	Device: Lens A (Test); Test toric lens A; Device: Lens B (control); Control toric lens B

Outcome Measures

Primary Outcome Measures

1. Lens Handling [1 month]

   Subjective ratings on lens handling were measured by ease of insertion and removal on a scale of 0-10 with 10 being very easy for handling.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

• Is between 18 and 40 years of age (inclusive)

• Has had a self-reported visual exam in the last two years

• Is an adapted soft contact lens wearer

• Is not a habitual wearer of either study lens

• Has a contact lens spherical prescription between +4.00 to - 10.00 (inclusive)Best corrected visual acuity of 20/30 or better in either eye

• Have contact lens prescription of no less than -0.75D of astigmatism and no more than -2.25 D in both eyes.

• Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.

• Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.

• Has clear corneas and no active ocular disease

• Has read, understood and signed the information consent letter.

• Patient contact lens refraction should fit within the available parameters of the study lenses.

• Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).

• Is willing to comply with the visit schedule

Exclusion Criteria:

A person will be excluded from the study if he/she:

• A person was excluded from the study if he/she:

• Has a CL prescription outside the range of the available parameters of the study lenses.

• Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye.

• Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)

• Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.

• Presence of clinically significant (grade 2-4) anterior segment abnormalities

• Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.

• Slit lamp findings that would contraindicate contact lens wear such as:

• Pathological dry eye or associated findings

• Pterygium, pinguecula, or corneal scars within the visual axis

• Neovascularization > 0.75 mm in from of the limbus

• Giant papillary conjunctivitis (GCP) worse than grade 1

• Anterior uveitis or iritis (past or present)

• Seborrheic eczema, Seborrheic conjunctivitis

• History of corneal ulcers or fungal infections

• Poor personal hygiene

• Has a known history of corneal hypoesthesia (reduced corneal sensitivity)

• Has aphakia, keratoconus or a highly irregular cornea.

• Has Presbyopia or has dependence on spectacles for near work over the contact lenses.

• Has undergone corneal refractive surgery.

• Is participating in any other type of eye related clinical or research study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Autonomous University (UNAM)	Mexico City	Código	Mexico	54090

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Rubén Velázquez Guerrero, MSc., FIACLE, National Autonomous University (UNAM)

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 19, 2021

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT05097144
• Other Study ID Numbers: EX-MKTG-128
• First Posted: Oct 28, 2021
• Last Update Posted: Aug 24, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Astigmatism

Study Results

Participant Flow

Arm/Group Title	Overall Study
Arm/Group Description	Subjects wear test lenses (Lens A) for one month and then cross-over to wear to control lens B for one month. Lens A (Test): Test toric lens A Lens B (control): Control toric lens B
Period Title: Overall Study
STARTED	36
COMPLETED	36
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Subjects wear test lenses (Lens A) for one month and then cross-over to wear to control lens B for one month. Lens A (Test): Test toric lens A Lens B (control): Control toric lens B
Overall Participants	36
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	36 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.6 (6.8)
Sex: Female, Male (Count of Participants)
Female	28 77.8%
Male	8 22.2%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Mexico	36 100%

Outcome Measures

1. Primary Outcome

Title	Lens Handling
Description	Subjective ratings on lens handling were measured by ease of insertion and removal on a scale of 0-10 with 10 being very easy for handling.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lens A (Test)	Lens B (Control)
Arm/Group Description	Subjects wore test lenses (Lens A) for one month and then cross-over to wear to control lens B for one month. Lens A (Test): Test toric lens A	Subjects wore control lenses (Lens B) for one month and then cross-over to wear Test lens A for one month. Lens B (control): Control toric lens B
Measure Participants	36	36
Mean (Standard Deviation) [units on a scale]	9.47 (1.00)	8.33 (1.54)

Adverse Events

Time Frame	From dispense up to 1 month on each study lens, a total of two months.
Arm/Group Title	Lens A (Test)		Lens B (Control)
Arm/Group Description	Subjects wore test lenses (Lens A) for one month and then cross-over to wear to control lens B for one month. Lens A (Test): Test toric lens A		Subjects wore control lenses (Lens B) for one month and then cross-over to wear Test lens A for one month. Lens B (control): Control toric lens B
All Cause Mortality
	Lens A (Test)		Lens B (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/36 (0%)
Serious Adverse Events
	Lens A (Test)		Lens B (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/36 (0%)
Other (Not Including Serious) Adverse Events
	Lens A (Test)		Lens B (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/36 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.