Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01294384

Enrollment

305

Registered

2011-02-11

Start date

2011-05-01

Completion date

2012-09-25

Last updated

2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes

Brief summary

This study will investigate the safety, efficacy and acceptability of two new eye drop formulations compared with Refresh Tears® in patients with dry eye disease.

Interventions

DRUGcarboxymethylcellulose sodium based New Eye Drop Formulation 1

1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.

DRUGcarboxymethylcellulose sodium based New Eye Drop Formulation 2

1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.

DRUGcarboxymethylcellulose sodium based Eye Drops

1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Current use of an artificial tear product at least twice daily for at least 3 months, on average * Ability/agreement to continue wearing existing spectacle correction (glasses) during study

Exclusion criteria

* Anticipated contact lens wear during study or contact lens use within 6 months * Active ocular infection or allergy * Use of any topical ophthalmic medications (eg, topical ophthalmic steroids, glaucoma drops) within 2 weeks * Use of any topical cyclosporine products within 3 months

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Ocular Surface Disease Index© (OSDI) Score	Baseline, Day 90	The OSDI is a questionnaire consisting of 12 questions assessing severity of dry eye using a 5-point scale where 0=none of the time to 4=all of the time. The total score is the sum of the individual scores normalized (standardized) to a severity scale of 0=no symptoms (best score) to 100=maximum severity (worst score). A negative change from Baseline indicated improvement.

Secondary

Measure	Time frame	Description
Percentage of Participants Much Better or Better in Near Visual Acuity (Low Contrast)	Baseline, Day 90	Near Visual Acuity was determined using the number of letters read correctly on a low contrast eye chart (gray letters on a white background). An increase in the number of letters read correctly indicated improvement. Much Better is defined as an increase of 10 or more letters read correctly at Day 90 compared to the worse eye at Baseline. Better is defined as an increase of 5 to 9 letters read correctly at Day 90 compared to the worse eye at Baseline.
Percentage of Participants Much Better or Better in Near Visual Acuity (High Contrast)	Baseline, Day 90	Near Visual Acuity was determined using the number of letters read correctly on a high contrast eye chart (black letters on a white background). An increase in the number of letters read correctly indicated improvement. Much Better is defined as an increase of 10 or more letters read correctly at Day 90 compared to the worse eye at Baseline. Better is defined as an increase of 5 to 9 letters read correctly at Day 90 compared to the worse eye at Baseline.
Change From Baseline in Tear Break-Up Time (TBUT)	Baseline, Day 90	TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from Baseline indicated improvement.
Change From Baseline in Visual Analog (VAS) Symptom Scale: Dryness	Baseline, Day 90	The participant rated the severity of their dry eye symptom: dryness using a VAS scale. Participants put a mark on a 100 millimeter line where 0 (far left on the line)=no symptoms to 100 (far right on the line)=most severe symptoms.
Change From Baseline in Conjunctival Staining	Baseline, Day 90	The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale where 0=no staining to 5=severe staining over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represented a decrease in the severity of conjunctival staining (improvement).
Change From Baseline in Schirmer Test	Baseline, Day 90	The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye where Normal=greater than or equal to 10 millimeters (mm) of tears and Dry Eye=less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicated an increase in tears (improvement).
Change From Baseline in Corneal Staining	Baseline, Day 90	The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale where 0=no staining to 5=severe staining over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative number change from baseline represented a decrease in corneal staining (improvement).

Countries

Australia, Canada

Participant flow

Participants by arm

Arm	Count
New Eye Drop Formulation 1 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.	101
New Eye Drop Formulation 2 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.	100
Refresh Tears® 1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.	104
Total	305

Baseline characteristics

Characteristic	Total	New Eye Drop Formulation 1	New Eye Drop Formulation 2	Refresh Tears®
Age, Customized 40 to 60 years	118 Participants	42 Participants	33 Participants	43 Participants
Age, Customized < 40 years	29 Participants	9 Participants	13 Participants	7 Participants
Age, Customized > 60 years	158 Participants	50 Participants	54 Participants	54 Participants
Sex: Female, Male Female	248 Participants	78 Participants	80 Participants	90 Participants
Sex: Female, Male Male	57 Participants	23 Participants	20 Participants	14 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	0 / 102	0 / 101	0 / 103
serious Total, serious adverse events	2 / 102	2 / 101	1 / 103

Outcome results

Primary

Change From Baseline in Ocular Surface Disease Index© (OSDI) Score

The OSDI is a questionnaire consisting of 12 questions assessing severity of dry eye using a 5-point scale where 0=none of the time to 4=all of the time. The total score is the sum of the individual scores normalized (standardized) to a severity scale of 0=no symptoms (best score) to 100=maximum severity (worst score). A negative change from Baseline indicated improvement.

Time frame: Baseline, Day 90