NCT03682809

Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort

Completed Phase 4 Results posted Last updated 6 April 2020

What this trial tests

Phase 4 trial testing Systane Complete in Contact Lens Discomfort in 46 participants. Completed in 23 March 2019.

Timeline

19 November 2018

Primary endpoint
23 March 2019

23 March 2019

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	46
Start date	19 November 2018
Primary completion	23 March 2019
Estimated completion	23 March 2019
Sites	3 locations across United States

Drugs / interventions tested

• Systane Complete — full drug profile →

Conditions studied

• Contact Lens Discomfort — all drugs for Contact Lens Discomfort →
• Dry Eye — all drugs for Dry Eye →

Sponsor

University of Alabama at Birmingham

Who can join

18 and older, any sex, with Contact Lens Discomfort or Dry Eye. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Contact Lens Symptoms Primary · Baseline through 2 Weeks

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 cldeq-8 (worse eye)

Group	Value	95% CI
Systane Complete	20.41	± 5.40
No Treatment	18.92	± 4.92

2 week cldeq-8 (worse eye)

Group	Value	95% CI
Systane Complete	12.86	± 6.40
No Treatment	17.92	± 5.30

Baseline cldeq-4 (worse eye)

Group	Value	95% CI
Systane Complete	10.91	± 3.28
No Treatment	10.38	± 2.41

2 week cldeq-4 (worse eye)

Group	Value	95% CI
Systane Complete	7.14	± 3.50
No Treatment	10.13	± 2.83

End of Day Eye Comfort Secondary · Baseline through 2 Weeks

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.

Speed Score Baseline (worse eye)

Group	Value	95% CI
Systane Complete	10.27	± 3.60
No Treatment	9.67	± 3.93

Speed Score 2 weeks (worse eye)

Group	Value	95% CI
Systane Complete	7.55	± 4.31
No Treatment	9.29	± 4.14

Corneal Staining Secondary · Baseline through 2 Weeks

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.

Corneal Staining Extent (baseline)

Group	Value	95% CI
Systane Complete	1.73	± 2.45
No Treatment	1.63	± 2.50

Corneal Staining Depth (baseline)

Group	Value	95% CI
Systane Complete	1.22	± 1.54
No Treatment	0.92	± 1.32

Corneal Staining Type (baseline)

Group	Value	95% CI
Systane Complete	1.18	± 1.56
No Treatment	0.92	± 1.32

Corneal Staining Extent (2 weeks)

Group	Value	95% CI
Systane Complete	1.41	± 2.42
No Treatment	1.75	± 1.98

Corneal Staining Depth (2 weeks)

Group	Value	95% CI
Systane Complete	0.91	± 1.38
No Treatment	1.04	± 1.30

Corneal Staining Type (2 weeks)

Group	Value	95% CI
Systane Complete	0.86	± 1.36
No Treatment	0.92	± 1.06

Schirmer's I Test Without Anesthetic Secondary · Baseline through 2 Weeks

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.

Schirmers Strip Baseline

Group	Value	95% CI
Systane Complete	15.68	± 9.70
No Treatment	20.88	± 10.65

Schirmers Strip (2 weeks)

Group	Value	95% CI
Systane Complete	15.41	± 9.29
No Treatment	18.30	± 10.69

Tear Break-Up Time (TBUT) Secondary · Baseline through 2 Weeks

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.

Tear Break Up Time (seconds) (baseline)

Group	Value	95% CI
Systane Complete	7.70	± 5.20
No Treatment	8.50	± 5.10

Tear Break Up Time (seconds) (2 weeks)

Group	Value	95% CI
Systane Complete	8.57	± 4.73
No Treatment	8.80	± 5.08

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Lubricating drops for contact lens discomfort in adults.
   Caffery B, Pucker AD, Chidi-Egboka NC, Obinwanne CJ, et al · · 2024 · cited 3× · PMID 39234924 · DOI 10.1002/14651858.cd015751.pub2