Comparison of Two Silicone Hydrogel Toric Contact Lenses

NCT03392532 | Completed Results FDA Device

• 1 other identifier: CLC127-C001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to compare the performance of two different types of Alcon soft toric study contact lenses to obtain information on study lens orientation.

Conditions

Astigmatism

Keywords

Astigmatism; Axis orientation

Outcome Measures

Primary Outcomes (1)

• Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location)

  Each lens was classified based on whether the absolute difference between the axis location and 90° was less than or equal to 30° (ie, lens axis located between the 60° and 120° axis inclusive). Inferential testing was not planned for this primary effectiveness endpoint.

  Day 1, 10 minutes after lens insertion, each product

Study Arms (2)

AOHG toric, then AO toric

OTHER

Lotrafilcon B toric contact lenses with HYDRAGLYDE, followed by lotrafilcon B toric contact lenses, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2.

Device: Lotrafilcon B toric contact lenses with HYDRAGLYDE; Device: Lotrafilcon B toric contact lenses

AO toric, then AOHG toric

OTHER

Lotrafilcon B toric contact lenses, followed by lotrafilcon B toric contact lenses with HYDRAGLYDE, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2.

Device: Lotrafilcon B toric contact lenses with HYDRAGLYDE; Device: Lotrafilcon B toric contact lenses

Interventions

Lotrafilcon B toric contact lenses with HYDRAGLYDE DEVICE

Silicone hydrogel soft contact lenses for astigmatism

Also known as: AIR OPTIX® plus HYDRAGLYDE® for Astigmatism contact lenses, AOHG for Astigmatism

AO toric, then AOHG toric; AOHG toric, then AO toric

Lotrafilcon B toric contact lenses DEVICE

Silicone hydrogel soft contact lenses for astigmatism

Also known as: AIR OPTIX® for Astigmatism contact lenses, AO for Astigmatism

AO toric, then AOHG toric; AOHG toric, then AO toric

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Successful wear of soft contact lenses for vision correction in both eyes during the past 3 months for a minimum of 3 days per week and 8 hours per day
• Astigmatism
• Requires contact lenses
• Best corrected visual acuity of 20/25 or better in each eye

You may not qualify if:

• Any eye condition that contraindicates contact lens wear, as determined by the Investigator
• Any eye surgery that contraindicates contact lens wear, as determined by the Investigator

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Alcon Investigative Site

Johns Creek, Georgia, 30097, United States

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: CDMA Project Lead, CDMA Vision Care
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Alcon, A Novartis Division

  Alcon, A Novartis Division

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 8, 2018
• Study Start: January 4, 2018
• Primary Completion: January 26, 2018
• Study Completion: January 26, 2018
• Last Updated: January 29, 2019
• Results First Posted: January 29, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)