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Dry EyeNCT01791426

A Study to Evaluate the Performance and Safety of Artelac Rebalance® Versus Vismed in the Management of Dry Eye

A study testing Artelac Rebalance and Vismed in people with Dry Eye, run by Bausch & Lomb Incorporated.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The objective of this investigation is to show that the performance of Artelac Rebalance eye drops is non-inferior to that of Vismed eye drops in subjects with moderate to severe dry eye, and to assess the safety of Artelac Rebalance after a 90-day (± 10 day) treatment administered 3 to 5 times per day. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye
What is being tested?
Artelac Rebalance and Vismed
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
May 2013to Oct 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who have been using tear substitutes for at least 3 months prior to inclusion, and who will use preservative-free ART (Artelac® UNO CL hypromellose 0.32% w/v eye drops, single dose unit) up to 6 times a day for at least 2 weeks immediately prior to randomization
  • Subjects with at least 1 eye with the following signs of keratoconjunctivitis sicca at 2 consecutive visits (Visit 1[Screening] and Visit 2 [Randomization])
  • Schirmer test without anesthesia of ≤ 9 mm/5min
  • Tear break-up time of ≤ 10sec (mean of 3 measurements)
  • Total ocular surface staining score ≥ 4 and ≤ 9. This assessment combines corneal fluorescein staining and nasal and temporal bulbar conjunctival lissamine green staining, each graded 0-5 according to the Oxford Scheme
  • Subjects who have a decimal visual acuity (VA) with habitual correction equal to or better than 0.1 (Snellen E chart) in both eyes
  • Subjects who are receiving stable systemic treatment (unchanged for 1 month or longer)

Who cannot join

  • Subjects with moderate or severe blepharitis
  • Subjects who have severe ocular dryness accompanied by 1 of the following:
  • Lid abnormality (except mild blepharitis)
  • Corneal disease
  • Ocular surface metaplasia
  • Filamentary keratitis
Show all 20Show fewer
  • Corneal neovascularization
  • Subjects who currently wear contact lenses or have worn contact lenses within 90 days prior to study start
  • Subjects who have received ocular surgery, including laser surgery, in either eye within 180 days prior to study start
  • Subjects with a history of ocular trauma, non-dry eye ocular inflammation, or ocular infection within 90 days prior to study start
  • Subjects with a history of ocular allergic disease or ocular herpes within
  • 1 year prior to study start
  • Subjects with a history of any inflammatory ulcerative keratitis, recurrent corneal erosion, or uveitis
  • Subjects with known hypersensitivity or contraindications to any of the ingredients in the test or comparator products
  • Subjects with planned initiation of, or changes to, concomitant medication that could affect dry eye within 30 days of Visit 1 (Screening) or during the study
  • Subjects who have received ocular therapy (either eye) with any ophthalmic medication, except tear substitutes, within 2 weeks prior to study start
  • Subjects expected to receive ocular therapy during the study
  • Subjects treated with topical ocular steroidal or non-steroidal anti- inflammatory medication within 30 days prior to study start
  • Subjects expected to receive ocular therapy with immunosuppressants (eg, cyclosporine) during the study or who have used ocular immunosuppressants within 90 days prior to study start
  • Subjects who have received occlusion therapy with lacrimal or punctum plugs within 90 days prior to study start

About this study

The objective of this investigation is to show that the performance of Artelac Rebalance eye drops is non-inferior to that of Vismed eye drops in subjects with moderate to severe dry eye, and to assess the safety of Artelac Rebalance after a 90-day (± 10 day) treatment administered 3 to 5 times per day.

Read the detailed description

Artelac Rebalance and Vismed are in compliance with European Directives (CE marked) products in the European Union (EU).

Conditions
Dry Eye
Being tested
Artelac Rebalance, Vismed
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Artelac RebalanceDevice

    Instill 1 drop of the Artelac Rebalance eye drops in each eye 3 to 5 times per day for 90(± 10) day treatment.

  • VismedDevice

    Instill 1 drop of the Vismed eye drops in each eye 3 to 5 times per day for 90(± 10) day treatment.

Study groups in NCT01791426
Study groupRoleWhat they receive
Artelac RebalanceExperimentalArtelac Rebalance ophthalmic solution contains 0.15% hyaluronic acid, is unpreserved and presented in single dose units with a fill volume of 0.5 mL.
Receives: Device: Artelac Rebalance
VismedActive comparatorVismed ophthalmic solution, contains 0.18% sodium hyaluronate, is unpreserved and presented in single dose units with a fill volume of 0.3 mL.
Receives: Device: Vismed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combined Ocular Surface Staining Score

    Total combined ocular surface staining grade of 0-15 combining corneal fluorescein staining score, nasal and temporal bulbar conjunctiva lissamine green staining score (each graded 0-5 on the Oxford Scheme) in the study eye.

    Measured: Mean change from baseline (CFB) to visit 4 (day 28)

Secondary outcomes (6)

  1. Combined Ocular Surface Staining Score

    Mean CFB in the study eye at Visits 3, 4 and 5 in total combined ocular surface staining score.

    Measured: Mean CFB to visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)

  2. Corneal Fluorescein Staining Score

    Mean CFB in the study eye in corneal fluorescein staining score at each follow-up visit

    Measured: Mean CFB at each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)

  3. Nasal Conjunctival Lissamine Green Staining

    Mean CFB in the study eye in nasal conjunctival lissamine green staining at each follow-up visit.

    Measured: Mean CFB at each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)

  4. Temporal Conjunctival Lissamine Green Staining

    Mean CFB in the study eye in temporal conjunctival lissamine green staining at each follow-up visit

    Measured: Mean CFB at each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)

  5. Tear Film Break-up Time

    Mean CFB in the study eye in tear film break-up time (TFBUT) at each follow-up visit.

    Measured: Mean CFB at each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)

  6. Study Drop Sensation

    Study drop sensation, as reported by subject in subject diary

    Measured: Each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionOct 2013
  4. Study completionOct 2013

Why it stopped: Adjustment of company focus due to acquision by Valeant Pharmaceuticals

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01791426
Sponsor's protocol ID
810
Status last verified
Oct 2013
First submitted
4 Feb 2013
Last updated
11 Oct 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Artelac Rebalance and Vismed in people with Dry Eye, run by Bausch & Lomb Incorporated.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined Ocular Surface Staining Score (time frame: Mean change from baseline (CFB) to visit 4 (day 28)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01791426.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2013.

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