Recruiting

Senofilcon A

Sponsor:

University of Illinois at Chicago

Code:

NCT04096898

Conditions

Moderate to Severe Dry Eye Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Senofilcon A contact lens

Study Details

Brief summary:

A clinical trial using Senofilcon A daily lenses in the treatment of moderate to severe dry eye. This a comparison between signs and symptoms prior to and during treatment.

Conditions

Moderate to Severe Dry Eye Disease

Study ID

NCT04096898

Start date

Apr 23, 2018

Status verified date

Mar, 2020

Completion date

Dec 31, 2020

Anticipated

Primary completion date

Dec 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Confirmed diagnosis of moderate to severe dry eye associated with either Graft-versus-host disease (GVHD), Sjogren syndrome, idiopathic dry eyes, or minimal limbal cell deficiency
  • A baseline Schirmer tear test (1) of less than 5 mm at 5 minutes without anesthesia
  • Have a visual analog score for comfort of 50 or less (scale of 1-100, with 100 meaning perfect ocular comfort and 1 meaning severe ocular pain)
  • Ability or the resources to insert and remove the study lenses
  • An OSDI score greater than 42
  • A willingness to sign an informed consent

Exclusion Criteria:

  • No dry eyes or mild dry eyes
  • A baseline Schirmer tear test (1) of greater than 5 mm of wetting at 5 minutes
  • Dry eye comfort score of greater than 50 on a visual analog scale
  • Unable to insert or remove the study lenses (or have a family member do so)
  • Have an OSDI score less than 42
  • Has been diagnosed with neurotrophic keratopathy in either eye
  • Unwilling to enroll in the study, and unwilling to provide signed informed consent to participate in the study

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Senofilcon A contact lens

Senofilcon lenses will be tested in moderate to severe dry eye patients to determine their efficacy in reducing discomfort associated with dry eye.

Primary outcome measure

  • Ocular Surface Disease Index (OSDI) [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Timothy T McMahon, OD

312-996-5410timomcma@uic.edu

Jacob Merriman

312-996-8041jmerr@uic.edu

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Jacob Merriman

312-996-8041jmerr@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Mar 24, 2020

Last verified

Mar, 2020

Keywords

  • dry eye

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2020-03-24.