Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort

NCT03682809 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 000522017
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

Brief Summary

Clinicians commonly use artificial tears off label for treating contact lens (CL) discomfort and the dry eye associated with CLs because new artificial tear formulations have the potential to outperform the available CL rewetting drops. While off-label, McDonald et al. have previously shown that using a common artificial tear, Systane Ultra, before and after CL use is an effective means for treating daily disposable CL wears who have CL discomfort. Recently, a new formulation of artificial tears, Systane Complete, was released to the market. Systane Complete is a unique formulation that has combined elements from both Systane Ultra (indicated for aqueous deficient dry eye) and Systane Balance (indicated for evaporative dry eye) to create an artificial tear with an indication for aqueous deficient, evaporative, and mixed (both aqueous deficient and evaporative) dry eye. Thus, the goal of this study is to determine in a randomized clinical trial if Systane Complete is able to effectively improve the symptoms of patients who have CL discomfort.

Conditions

Contact Lens Discomfort; Dry Eye

Keywords

Artificial Tears; Systane Complete; Contact Lens Discomfort; Dry Eye; Daily Disposable Contact Lenses

Outcome Measures

Primary Outcomes (1)

• Contact Lens Symptoms

  Improvement in contact lens symptoms as measured with the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) and CLDEQ-4 at 2 weeks compared to baseline. The CLDEQ-8 score range is 0 to 37 with 0 being the best score. Subjects were required to have a CLDEQ-8 of at least 12 in order to participate. The CLDEQ-4 is a subset of the CLDEQ-8, and it was also reported because it is a unidimensional measure of ocular discomfort in contact lens wearers. The CLDEQ-4 has a score range of 0 to 18 with 0 being the best score.

  Baseline through 2 Weeks

Secondary Outcomes (4)

• End of Day Eye Comfort

  Baseline through 2 Weeks

• Corneal Staining

  Baseline through 2 Weeks

• Schirmer's I Test Without Anesthetic

  Baseline through 2 Weeks

• Tear Break-Up Time (TBUT)

  Baseline through 2 Weeks

Study Arms (2)

Systane Complete

EXPERIMENTAL

Subjects randomized to this group will be asked to use Systane Complete once before and after contact lens use.

Drug: Systane Complete

No Treatment

NO INTERVENTION

Subjects randomized to this group will not receive a treatment.

Interventions

Systane Complete DRUG

Systane Complete is an artificial tear indicated for patients who have evaporative, aqueous deficient, or mixed dry eye.

Systane Complete

Eligibility Criteria

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

You may qualify if:

• Self-reported contact lens discomfort
• Contact Lens Dry Eye Questionnaire (CLDEQ)-8 scores ≥ 12
• Daily disposable contact lens wearer
• Best-corrected visual acuity of 20/30 or better

You may not qualify if:

• All other contact lens types (e.g., currently wearing two week or monthly replacement contact lenses or hard contact lenses)
• Non-compliant daily disposable contact lens wearers (must regularly replace contact lenses daily)
• Systemic health conditions known to alter tear film physiology
• History of ocular surgery within the past 12 months
• History of severe ocular trauma, active ocular infection, or inflammation
• Currently using Accutane or eye medications
• Pregnant or breast feeding

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Southern College of Optometry: collaborator
• Lindenhurst Eye Physicians & Surgeons, PC: collaborator
• Alcon Research: collaborator

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Lindenhurst Eye Physicians & Surgeons, P.C.

Babylon, New York, 11702, United States

Location

Southern College of Optometry

Memphis, Tennessee, 38104, United States

Location

Related Publications (1)

• McDonald M, Schachet JL, Lievens CW, Kern JR. Systane(R) ultra lubricant eye drops for treatment of contact lens-related dryness. Eye Contact Lens. 2014 Mar;40(2):106-10. doi: 10.1097/ICL.0000000000000018.

  PMID: 24552755 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Limitations and Caveats

The results presented in this record have no known limitations or caveats.

Results Point of Contact

• Title: Dr. Andrew Pucker
• Organization: The University of Alabama at Birmingham

apucker@uab.edu

920-579-2900

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The patients who are randomized to Systane Complete will be masked to the brand of the artificial tears. There will be a masked examiner who does not know the subject's study group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: One group will be randomized Systane Complete, and one group will be randomized to no treatment.

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: September 25, 2018
• Study Start: November 19, 2018
• Primary Completion: March 23, 2019
• Study Completion: March 23, 2019
• Last Updated: April 6, 2020
• Results First Posted: April 6, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)