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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02117687
Recruitment Status : Completed
First Posted : April 21, 2014
Results First Posted : February 19, 2016
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Keratoconjunctivitis Sicca Drug: carboxymethylcellulose 0.5%/glycerin 0.9% Drug: sodium hyaluronate 0.18% Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Actual Study Start Date : May 14, 2014
Actual Primary Completion Date : January 27, 2015
Actual Study Completion Date : March 17, 2015


Arm Intervention/treatment
Active Comparator: OPTIVE FUSION™
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.
Drug: 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.
Other Name: OPTIVE FUSION™

Active Comparator: VISMED® Multi
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.
Drug: 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.
Other Name: VISMED® Multi




Primary Outcome Measures :
  1. Change From Baseline in Global Ocular Staining Score in the Study Eye [ Time Frame: 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 :
  1. Change From Baseline in Global Ocular Staining Score in the Study Eye [ Time Frame: 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.

  2. Change From Baseline in Ocular Surface Disease Index© (OSDI) Score [ Time Frame: 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.

  3. Change From Baseline in the Schirmer Test in the Study Eye [ Time Frame: 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).

  4. Subject Assessment of Dry Eye Symptoms on a 5-Point Scale [ Time Frame: Baseline, Day 35, Month 3 ]
    Subjects assess dry eye symptoms on a 5-point scale (none, mild, moderate, severe, very severe).

  5. Subject Global Assessment of Treatment Efficacy on a 5-Point Scale [ Time Frame: 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).

  6. Subject Assessment of Treatment Acceptability on a 5-Point Scale [ Time Frame: Day 35 ]
    Subjects assess treatment acceptability (likability and comfort) on a 5-point scale (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree).

  7. Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale [ Time Frame: Day 35, Month 3 ]
    Investigators assess global treatment efficacy on a 4-point scale (very satisfactory, satisfactory, poor, very poor).

  8. Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye [ Time Frame: 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).

  9. Work Productivity and Activity Impairment Questionnaire Score [ Time Frame: 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.

  10. Change From Baseline in Corneal Staining in the Study Eye [ Time Frame: 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).

  11. Change From Baseline in Conjunctival Staining in the Study Eye [ Time Frame: 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).

  12. Conjunctival Hyperaemia in the Study Eye [ Time Frame: 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).

  13. Study Product Use [ Time Frame: Day 8, Day 35, Month 3 ]
    The number of times the study product is administered per day is recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117687


Locations
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France
Paris, France
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
Publications:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02117687    
Other Study ID Numbers: MAF-AGN-OPH-DE-016
First Posted: April 21, 2014    Key Record Dates
Results First Posted: February 19, 2016
Last Update Posted: April 18, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Carboxymethylcellulose Sodium
Hyaluronic Acid
Glycerol
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents
Laxatives
Gastrointestinal Agents
Cryoprotective Agents