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Comparison of Two Silicone Hydrogel Toric Contact Lenses

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ClinicalTrials.gov Identifier: NCT03392532
Recruitment Status : Completed
First Posted : January 8, 2018
Results First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

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.

Condition or disease Intervention/treatment Phase
Astigmatism Device: Lotrafilcon B toric contact lenses with HYDRAGLYDE Device: Lotrafilcon B toric contact lenses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Axis Orientation Comparison of Two Silicone Hydrogel Toric Contact Lenses
Actual Study Start Date : January 4, 2018
Actual Primary Completion Date : January 26, 2018
Actual Study Completion Date : January 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
AOHG toric, then AO toric
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
Silicone hydrogel soft contact lenses for astigmatism
Other Names:
  • AIR OPTIX® plus HYDRAGLYDE® for Astigmatism contact lenses
  • AOHG for Astigmatism

Device: Lotrafilcon B toric contact lenses
Silicone hydrogel soft contact lenses for astigmatism
Other Names:
  • AIR OPTIX® for Astigmatism contact lenses
  • AO for Astigmatism

AO toric, then AOHG toric
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
Silicone hydrogel soft contact lenses for astigmatism
Other Names:
  • AIR OPTIX® plus HYDRAGLYDE® for Astigmatism contact lenses
  • AOHG for Astigmatism

Device: Lotrafilcon B toric contact lenses
Silicone hydrogel soft contact lenses for astigmatism
Other Names:
  • AIR OPTIX® for Astigmatism contact lenses
  • AO for Astigmatism




Primary Outcome Measures :
  1. Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location) [ Time Frame: Day 1, 10 minutes after lens insertion, each product ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Other protocol-specified inclusion criteria may apply

Exclusion Criteria:

  • 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
  • Other protocol-specified exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392532


Locations
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United States, Georgia
Alcon Investigative Site
Johns Creek, Georgia, United States, 30097
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Alcon, A Novartis Division Alcon, A Novartis Division
  Study Documents (Full-Text)

Documents provided by Alcon Research:
Study Protocol  [PDF] November 17, 2017
Statistical Analysis Plan  [PDF] December 11, 2017


Additional Information:
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03392532     History of Changes
Other Study ID Numbers: CLC127-C001
First Posted: January 8, 2018    Key Record Dates
Results First Posted: January 29, 2019
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Keywords provided by Alcon Research:
Astigmatism
Axis orientation
Additional relevant MeSH terms:
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Astigmatism
Refractive Errors
Eye Diseases