Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01010282

Enrollment

288

Registered

2009-11-10

Start date

2009-11-30

Completion date

2010-04-30

Last updated

2015-08-17

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

Conditions

Dry Eye Syndrome

Brief summary

This study will evaluate the safety, efficacy, and acceptability of two artificial tears compared to a currently available artificial tear in subjects with dry eye.

Interventions

DRUGGlycerin and Polysorbate 80 based artificial tear

1-2 drops in each eye, as needed, but at least twice daily

DRUGFormulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear

1-2 drops in each eye, as needed, but at least twice daily

DRUGFormulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear

1-2 drops in each eye, as needed, but at least twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Current use of an artificial tear at least twice daily, for at least three months prior to Day 1, on average * Ability/agreement to wear habitual correction (glasses) during study period

Exclusion criteria

* Known allergy or sensitivity to the study product(s) or its components * Anticipate contact lens wear during the study, or subject has worn contact lenses in the last six months * Chronic use of systemic medications which may affect a dry eye condition * Active ocular allergy or infection * Use of Restasis® or other topical cyclosporine products within 3 months prior to Day 1 * Current use of any topical ophthalmic medications, have used within 2 weeks prior to Day 1, or are likely to use during study.

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90	Baseline (Day 1), Day 90	Change from baseline in SESoD score at day 90. The SESoD is a 5-point scale where 0 equals no dryness, 1 equals trace dryness, 2 equals mild dryness, 3 equals moderate dryness, and 4 equals severe dryness. A negative number change from baseline indicates a decrease (improvement) in the symptom of dryness.

Secondary

Measure	Time frame	Description
Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90	Baseline (Day 1), Day 90	Change from baseline in the OSDI total score at day 90. 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) at Day 90	Baseline (Day 1), Day 90	Change from baseline in TBUT at day 90. 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).
Change From Baseline in Corneal Staining at Day 90	Baseline (Day 1), Day 90	Change from baseline in corneal staining at 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 (0=no staining, 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 represents a decrease in corneal staining (improvement).
Change From Baseline in Conjunctival Staining Severity Score at Day 90	Baseline (Day 1), Day 90	Change from baseline in conjunctival staining severity score at 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 (0=no staining, 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 represents a decrease in the severity of conjunctival staining (improvement).

Countries

United States

Participant flow

Participants by arm

Arm	Count
Artificial Tears Formulation 1 Artificial Tears Formulation 1	97
Artificial Tears Formulation 2 Artificial Tears Formulation 2	95
Glycerin and Polysorbate 80 Based Artificial Tear Glycerin and Polysorbate 80 based artificial tear	96
Total	288

Baseline characteristics

Characteristic	Artificial Tears Formulation 1	Artificial Tears Formulation 2	Glycerin and Polysorbate 80 Based Artificial Tear	Total
Age, Customized <30 years	6 participants	9 participants	4 participants	19 participants
Age, Customized >40 years	85 participants	77 participants	81 participants	243 participants
Age, Customized between 30 and 40 years	6 participants	9 participants	11 participants	26 participants
Sex: Female, Male Female	76 Participants	70 Participants	70 Participants	216 Participants
Sex: Female, Male Male	21 Participants	25 Participants	26 Participants	72 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	28 / 97	14 / 95	37 / 96
serious Total, serious adverse events	2 / 97	0 / 95	4 / 96

Outcome results

Primary

Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90

Change from baseline in SESoD score at day 90. The SESoD is a 5-point scale where 0 equals no dryness, 1 equals trace dryness, 2 equals mild dryness, 3 equals moderate dryness, and 4 equals severe dryness. A negative number change from baseline indicates a decrease (improvement) in the symptom of dryness.

Time frame: Baseline (Day 1), Day 90