A Safety and Efficacy Study of OPTIVE FUSION™ With VISMED® Multi for the Management of Dry Eye

Phase 4

Completed

• Conditions: Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Interventions: Drug: carboxymethylcellulose 0.5%/glycerin 0.9%; Drug: sodium hyaluronate 0.18%

• Registration Number: NCT02117687
• Lead Sponsor: Allergan

Brief Summary

This study will evaluate the safety and efficacy of OPTIVE FUSION™ compared to VISMED® Multi for the management of dry eye.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-04-16
• Study First Posted: 2014-04-21
• Study Start: 2014-05-14
• Primary Completion: 2015-01-27
• Study Completion: 2015-03-17
• Results First Submitted: 2016-01-22
• Results First Submitted QC: 2016-01-22
• Results First Posted: 2016-02-19
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Use of artificial tears for dry eye in both eyes for at least 3 months
• Use of preservative-free artificial tears at least twice daily for 2 weeks;

Exclusion Criteria

• Cataract, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK) surgery in the last 12 months
• Use of punctal plugs or contact lenses in the last month
• Active ocular allergy within last 2 years
• Best corrected visual acuity (BCVA) less than 20/200 in either eye

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPTIVE FUSION™	carboxymethylcellulose 0.5%/glycerin 0.9%	1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
VISMED® Multi	sodium hyaluronate 0.18%	1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Global Ocular Staining Score in the Study Eye	Baseline, Day 35	Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal.

Secondary Outcome Measures

Name	Time	Method
Subject Global Assessment of Treatment Efficacy on a 5-Point Scale	Baseline, Day 35, Month 3	Subjects assess global treatment efficacy compared to baseline on a 5-point scale (much worse, worse, about the same, improved, much improved).
Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye	Baseline, Day 35	TBUT is the time required for dry spots to appear on the surface of the eye after blinking in the worse eye. 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) and a negative number change from baseline indicates a decrease in TBUT (worsening).
Conjunctival Hyperaemia in the Study Eye	Baseline, Day 35, Month 3	Macroscopic conjunctival hyperemia (eye redness) is graded in the study eye on a 5-point scale (none, trace, mild, moderate, severe).
Change From Baseline in Ocular Surface Disease Index© (OSDI) Score	Baseline, Day 35	The OSDI is a 12-question survey for patients to document their dry eye disease symptoms on a 5-point scale (0=none of the time and 4=all of the time). Higher scores represent greater disability. 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 and a positive number change from baseline represents a worsening.
Change From Baseline in the Schirmer Test in the Study Eye	Baseline, Day 35	The Schirmer's Test measures the rate of secretion of tears produced by the study eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement) and a negative number change from baseline indicates a decrease in tears (worsening).
Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale	Day 35, Month 3	Investigators assess global treatment efficacy on a 4-point scale (very satisfactory, satisfactory, poor, very poor).
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale	Baseline, Day 35, Month 3	Subjects assess dry eye symptoms on a 5-point scale (none, mild, moderate, severe, very severe).
Subject Assessment of Treatment Acceptability on a 5-Point Scale	Day 35	Subjects assess treatment acceptability (likability and comfort) on a 5-point scale (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree).
Change From Baseline in Global Ocular Staining Score in the Study Eye	Baseline, Month 3	Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal.
Change From Baseline in Conjunctival Staining in the Study Eye	Baseline, Day 35, Month 3	The conjunctiva is the clear membrane covering the white surface of the eye. Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining) in the temporal and nasal locations. A negative number change from baseline represents a decrease in corneal staining (improvement) and a positive number change from baseline represents an increase in corneal staining (worsening).
Study Product Use	Day 8, Day 35, Month 3	The number of times the study product is administered per day is recorded.
Work Productivity and Activity Impairment Questionnaire Score	Baseline, Day 35, Month 3	The Work Productivity and Activity questionnaire assesses the effect of dry eye on the ability of subjects to work and perform regular activities on a scale from 0 to 10 during the past 7 days (0=dry eye had no effect on my work/daily activities to 10=dry eye completely prevented me from working/doing my daily activities). Since not all subjects were in full time employment during the study, not all items of the questionnaire were applicable to all subjects at each visit. Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Change From Baseline in Corneal Staining in the Study Eye	Baseline, Day 35, Month 3	The cornea is the transparent front part of the eye which covers the iris and pupil. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). A negative number change from baseline represents a decrease in corneal staining (improvement) and a positive number change from baseline represents an increase in corneal staining (worsening).