A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02280473

Enrollment

188

Registered

2014-10-31

Start date

2014-11-13

Completion date

2015-03-16

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 evaluate the safety and efficacy o fRefresh Optive® Gel Drops in patients with dry eye disease.

Interventions

DRUGRefresh Optive® Gel Drops

Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.

DRUGREFRESH LIQUIGEL®

REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 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 * Visual acuity of at least 20/32 (while wearing glasses, if necessary).

Exclusion criteria

* Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study * Cataract surgery, laser-assisted in situ keratomileusis \[LASIK\], or photorefractive keratectomy, within the last 6 months * Current eye infection or inflammation

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score	Baseline, Day 30	The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.

Secondary

Measure	Time frame	Description
Change From Baseline in the OSDI© Score	Baseline, Day 7	The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.
Change From Baseline in Tear Break-up Time (TBUT)	Baseline, Day 30	TBUT is the time 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 short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement). The eye with shorter average TBUT at baseline is reported for each patient.
Change From Baseline in the Combined Corneal and Conjunctival Staining Scores	Baseline, Day 30	The cornea is the transparent front part of the eye which covers the iris and pupil. The conjunctiva is the clear membrane covering the white surface of the eye. The cornea is divided into 5 zones and the nasal and temporal conjunctiva is divided into 6 zones. The combined staining score is based on the sum of the five zones on the cornea and the six zones on the conjunctiva. Each zone is graded on a 0-5 scale (0=None; 1=trace; 2=mild; 3=moderate; 4=severe; 5=very severe), for a total score ranging from 0-55. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of staining (improvement). The eye with higher score at baseline is reported for each subject.
Change From Baseline in the Schirmer Test	Baseline, Day 30	The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears.. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates improvement. The eye with the lower value at baseline is used for each subject.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Refresh Optive® Gel Drops Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.	94
REFRESH LIQUIGEL® REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.	94
Total	188

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	1
Overall Study	Lack of Efficacy	0	1
Overall Study	Lost to Follow-up	0	1

Baseline characteristics

Characteristic	Refresh Optive® Gel Drops	REFRESH LIQUIGEL®	Total
Age, Customized 18 to less than 30 years	11 Participants	13 Participants	24 Participants
Age, Customized 30 to 40 years	11 Participants	14 Participants	25 Participants
Age, Customized More than 40 years	72 Participants	67 Participants	139 Participants
Sex: Female, Male Female	78 Participants	75 Participants	153 Participants
Sex: Female, Male Male	16 Participants	19 Participants	35 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	7 / 94	5 / 94
serious Total, serious adverse events	0 / 94	1 / 94

Outcome results

Primary

The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.

Time frame: Baseline, Day 30