Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02117687
Other study ID # MAF-AGN-OPH-DE-016
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 14, 2014
Est. completion date March 17, 2015

Study information

Verified date April 2019
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date March 17, 2015
Est. primary completion date January 27, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Allergan

Countries where clinical trial is conducted

France,  United Kingdom, 

References & Publications (1)

Labetoulle M, Chiambaretta F, Shirlaw A, Leaback R, Baudouin C. Osmoprotectants, carboxymethylcellulose and hyaluronic acid multi-ingredient eye drop: a randomised controlled trial in moderate to severe dry eye. Eye (Lond). 2017 Oct;31(10):1409-1416. doi: 10.1038/eye.2017.73. Epub 2017 Apr 28. Erratum in: Eye (Lond). 2017 Oct;31(10 ):1512. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Global Ocular Staining Score in the Study Eye 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. Baseline, Day 35
Secondary Change From Baseline in Global Ocular Staining Score in the Study Eye 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. Baseline, Month 3
Secondary Change From Baseline in Ocular Surface Disease Index© (OSDI) Score 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. Baseline, Day 35
Secondary Change From Baseline in the Schirmer Test in the Study Eye 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). Baseline, Day 35
Secondary Subject Assessment of Dry Eye Symptoms on a 5-Point Scale Subjects assess dry eye symptoms on a 5-point scale (none, mild, moderate, severe, very severe). Baseline, Day 35, Month 3
Secondary Subject Global Assessment of Treatment Efficacy on a 5-Point Scale Subjects assess global treatment efficacy compared to baseline on a 5-point scale (much worse, worse, about the same, improved, much improved). Baseline, Day 35, Month 3
Secondary Subject Assessment of Treatment Acceptability on a 5-Point Scale Subjects assess treatment acceptability (likability and comfort) on a 5-point scale (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree). Day 35
Secondary Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale Investigators assess global treatment efficacy on a 4-point scale (very satisfactory, satisfactory, poor, very poor). Day 35, Month 3
Secondary Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye 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). Baseline, Day 35
Secondary Work Productivity and Activity Impairment Questionnaire Score 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. Baseline, Day 35, Month 3
Secondary Change From Baseline in Corneal Staining in the Study Eye 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). Baseline, Day 35, Month 3
Secondary Change From Baseline in Conjunctival Staining in the Study Eye 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). Baseline, Day 35, Month 3
Secondary Conjunctival Hyperaemia in the Study Eye Macroscopic conjunctival hyperemia (eye redness) is graded in the study eye on a 5-point scale (none, trace, mild, moderate, severe). Baseline, Day 35, Month 3
Secondary Study Product Use The number of times the study product is administered per day is recorded. Day 8, Day 35, Month 3
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04425551 - Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction N/A
Not yet recruiting NCT06379685 - Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface. Phase 1
Recruiting NCT04701086 - 3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis N/A
Active, not recruiting NCT03697876 - Safety and Tolerability of the Ophthalmic Gel PRO-165 Versus Artelac® Nightime Gel Phase 1
Terminated NCT02815293 - Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye Phase 3
Completed NCT02910713 - Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation N/A
Completed NCT04104997 - A Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of GLH8NDE After Single and Mutiple Ocular Administrations in Healthy Korean and Caucasian Volunteers Phase 1
Recruiting NCT02595606 - 0.3% Sodium Hyaluronate in the Treatment of Dry Eye of Diabetic Patients Phase 4
Completed NCT01711424 - An Observational Study of OPTIVE PLUS® for the Treatment of Dry Eye Disease N/A
Completed NCT01202747 - Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction Phase 2/Phase 3
Completed NCT01015209 - Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers Phase 1
Completed NCT00969280 - Acupuncture for Dry Eye Syndrome Phase 3
Completed NCT00756678 - Efficacy and Acceptability of Two Lubricant Eye Drops Phase 4
Completed NCT01496482 - Comparison of Evaporimetry With the Established Methods of Tear Film Measurement N/A
Completed NCT00739713 - Effects of Sea Buckthorn Oil on Dry Eye N/A
Completed NCT00370747 - Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome Phase 2
Completed NCT00349440 - Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy Phase 4
Completed NCT05162261 - to Evaluate the Effectiveness and Safety of the Tixel® , VS LipiFlow® in the Treatment of Meibomian Gland Dysfunction N/A
Completed NCT02871440 - A Two Comparator, Controlled Phase 3 Study in Patients With and Without Evaporative Dry Eye Phase 3
Completed NCT05042960 - Computer Screen Properties Study N/A