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NCT03392532 Clinical Trial

Comparison of Two Silicone Hydrogel Toric Contact Lenses

Astigmatism Clinical Trial

Official title:
Axis Orientation Comparison of Two Silicone Hydrogel Toric Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03392532
Other study ID # CLC127-C001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 4, 2018
Est. completion date January 26, 2018

Study information
Verified date January 2019
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date January 26, 2018
Est. primary completion date January 26, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Lotrafilcon B toric contact lenses with HYDRAGLYDE
Silicone hydrogel soft contact lenses for astigmatism
• Lotrafilcon B toric contact lenses
Silicone hydrogel soft contact lenses for astigmatism

Locations
Country Name City State
United States Alcon Investigative Site Johns Creek Georgia

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
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Completed NCT04536571 - Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses N/A
Completed NCT04613882 - Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses N/A
Completed NCT05039112 - Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses N/A
Recruiting NCT05611294 - Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction N/A
Completed NCT05633082 - A Clinical Performance of Two Soft Toric Contact Lenses N/A
Not yet recruiting NCT05506553 - Comparison of Aspheric Toric Intraocular Lenses for Micro-monovision N/A
Not yet recruiting NCT05561296 - Astigmatism Management With Iris-registration Guided Corneal Relaxing Incisions or Toric IOLs During Cataract Surgery N/A
Completed NCT02847169 - Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear N/A
Recruiting NCT02618018 - Clinical Evaluation of Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery N/A
Completed NCT02555098 - A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens N/A
Completed NCT02551796 - Early Changes Among FLEx, LASIK and FS-LASIK N/A
Completed NCT02550353 - Changes Between Lenticule Extraction and Femtosecond Laser-assisted Laser in Situ Keratomileusis N/A
Completed NCT02423109 - Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses N/A
Completed NCT02248766 - Clinical Performance of Habitual Wearers of Avaira Toric When Refitted With Clariti Toric Lenses N/A
Completed NCT01857102 - Toric Eye Strain and Stability Study N/A
Completed NCT01965288 - Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism N/A
Completed NCT02624791 - Evaluating and Improving Functional Driving Vision of Patients With Astigmatism N/A
Withdrawn NCT01680354 - Surgical Correction of Astigmatism N/A
Completed NCT01211535 - Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers N/A

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