Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03682809
Other study ID # 000522017
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 19, 2018
Est. completion date March 23, 2019

Study information

Verified date March 2020
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Soft contact lenses (CL) are the most common CL modality with over 140 million users world. Despite many improvements in CL materials and solutions, the advent of daily disposable CLs, and the addition of rewetting drops to improve CL comfort, research has shown that between 21% to 64% of CL wearers permanently discontinue CL use because of eye discomfort. Contact Lens Discomfort (CLD) as defined by the Tear Film and Ocular Surface Society (TFOS) "is a condition characterized by episodic or persistent adverse ocular sensations related to lens wear, either with or without visual disturbance, resulting from reduced compatibility between the CL and the eye's environment, which can lead to decreased wearing time and discontinuation of CL wear." TFOS further states that CLD is a multifactorial condition that stems from both CL (e.g., material design, fit, care system) and environmental factors (patient factors, medication compliance, external environmental factors, ocular environment). While environmental factors related to the patient such as age and sex are inherent, rewetting drops or artificial tears can be used to treat tear film deficiencies associated with CLD. The U.S. Food & Drug Administration (FDA) defines rewetting/lubricating drops as "an in-eye solution for use with CLs" that contains "one or more active ingredients (e.g., ophthalmic demulcents) in sufficient concentration to alleviate symptoms of discomfort from CL wear by physical means." Clinicians also commonly use artificial tears off label for treating CLD and the dry eye associated with CLs because artificial tear formulations have the potential to outperform CL rewetting drops. The FDA separately classifies artificial tears as topical drops that contain specific types of demulcents or emollients. 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 CLD. 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 Research Goal of this study is to determine in a randomized clinical trial if Systane Complete is able to effectively improve the symptoms of CLD suffers.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date March 23, 2019
Est. primary completion date March 23, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Intervention

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

Locations

Country Name City State
United States Lindenhurst Eye Physicians & Surgeons, P.C. Babylon New York
United States University of Alabama at Birmingham Birmingham Alabama
United States Southern College of Optometry Memphis Tennessee

Sponsors (4)

Lead Sponsor Collaborator
University of Alabama at Birmingham Alcon Research, Lindenhurst Eye Physicians & Surgeons, PC, Southern College of Optometry

Country where clinical trial is conducted

United States, 

References & Publications (1)

McDonald M, Schachet JL, Lievens CW, Kern JR. Systane® 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 End of Day Eye Comfort Improvement in eye symptoms as measured with the Standardized Patient Evaluation of Eye Dryness (SPEED) at 2 weeks compared to baseline. The scale range is 0 to 28 with 0 being the best score. Baseline through 2 Weeks
Secondary Corneal Staining Improvement in conjuctivial staining at two weeks compared to baseline using the Brien Holden Vision Institute (BHVI) scale, which measures five regions of the eye on a (0-4) scale (max of 20 per metric). A score 0 is the best possible score. Baseline through 2 Weeks
Secondary Schirmer's I Test Without Anesthetic Improvement in tear volume as measured in mm of wetting with a Schirmer's strip at 5 mins at 2 weeks compared to baseline. The score ranges is 0 mm to 35 mm with 35 mm being the best score. Baseline through 2 Weeks
Secondary Tear Break-Up Time (TBUT) Improvement in tear break up time as measured with a slit-lamp biomicroscope and sodium fluorescein in seconds at 2 weeks compared to baseline. Scores range for 0 to 60 seconds with 60 seconds being the best score. Baseline through 2 Weeks
See also
  Status Clinical Trial Phase
Completed NCT05027087 - The Effect of a Novel Blueberry Supplement on Dry Eye Disease Phase 3
Completed NCT05102409 - An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease Phase 2
Completed NCT06159569 - Performance and Tolerability of the Medical Device LACRIACT N/A
Completed NCT04081610 - Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution Phase 1
Completed NCT05062564 - Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye N/A
Completed NCT05825599 - PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms N/A
Completed NCT03418727 - Dry Eye Disease Study With Brimonidine Phase 2
Active, not recruiting NCT04425551 - Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction N/A
Recruiting NCT04527887 - Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED) Phase 4
Not yet recruiting NCT06379685 - Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface. Phase 1
Active, not recruiting NCT05618730 - Safety, Tolerability, Plug Retention and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B Phase 1
Completed NCT04553432 - Dry Eye OmniLenz Application of Omnigen Research Study Phase 4
Recruiting NCT04109170 - Dry Eye Evaluation System Based on Bioinformatics
Completed NCT04105842 - Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type N/A
Completed NCT05505292 - Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers Phase 4
Completed NCT04668131 - Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease N/A
Completed NCT06176651 - Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers Phase 4
Not yet recruiting NCT02218827 - Topical Steroid Treatment For Dry Eye N/A
Completed NCT02235259 - Efficacy and Safety of XG-104 for the Treatment of Dry Eye Phase 2
Completed NCT01959854 - Efficacy of Topical 0.2% Xanthan Gum in Patients With Dry Eye N/A