The purpose of this research study is to compare Systane Balance Lubricant Eye Drops to Preservative-Free 0.9% Saline as necessary to support Systane Balance reimbursement in France.
ID
Source
Brief title
Condition
- Ocular sensory symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Efficacy:
* Change from baseline in TFBUT at Day 35
Secondary outcome
Secondary Efficacy:
* Change from baseline in Total Ocular Surface Staining (TOSS) score at Day 35
* Change from baseline in OSDI score at Day 35
* Change from baseline in Impact of Dry Eye on Everyday Life (IDEEL) Treatment
Effectiveness score at Day 35
* Change from baseline in IDEEL Treatment Inconvenience score at Day 35
Supportive:
* Change from baseline in MGD score (Expressibility) at Day 35
* Change from baseline in MGD score (Meibum Quality) at Day 35
* Change from baseline in TFBUT at Day 15
* Change from baseline in TOSS score at Day 15
* Change from baseline in MGD score (Expressibility) at Day 15
* Change from baseline in MGD score (Meibum Quality) at Day 15
* Dosing frequency during Treatment Phase II.
Background summary
The tear film is a thin layer of moisture on the eye composed of a fatty layer
(exposed to the air), a viscous (gooey) layer next to the eye and a thicker
watery layer in the middle. Lipid deficient dry eye means that there is less
of the fatty layer in the tear film. As a result, the watery layer evaporates
quicker and the cells on the cornea become exposed to the air which causes the
burning, stinging, and redness symptoms. Often the eye responds with symptoms
such as itchiness and swelling. Treatment for dry eye disease is aimed at
relieving those symptoms. Lubricating eye drops try to replenish the fatty and
watery layers of the tear film so the cells on the cornea have less exposure to
air.
Study objective
The purpose of this research study is to compare Systane Balance Lubricant Eye
Drops to Preservative-Free 0.9% Saline as necessary to support Systane Balance
reimbursement in France.
Study design
Approximately 3,5 months (105 days, wash-out included), 2 arms, parallel
groups, multicenter, observer masked, randomized study:
* Systane Balance Lubricant Eyedrops (dosed 4x per day for 35 days & as often
as needed for an additional 55 days)
or
* Preservative-Free 0.9% Saline (dosed 4x per day for 35 days & as often as
needed for an additional 55 days)
Intervention
Not applicable
Study burden and risks
In a period of 3,5 months (105 days) patients need to come to the hospital 5
times for an ophthalmic examination. Each visit will take between 1 and 2 hours
of their time. None of the tests are experimental. After a wash-out period
(with preservative-Free 0.9% Saline), the subjects will receive orSystane
Balance Lubricant Eyedrops (dosed 4x per day for 35 days & as often as needed
for an additional 55 days) or Preservative-Free 0.9% Saline (dosed 4x per day
for 35 days & as often as needed for an additional 55 days)
There is no increased risk expected with the use of either one of the eye drops
used in this study.
The examinations that will be conducted during the study may cause some
discomfort.
The yellow dye (fluorescein) and green dye (lissamine) put in the eye for the
staining examinations could make the skin and bodily secretions and excretions
change color or cause some irritation.
One may experience side effects related to the use of the study eye drops which
are expected to be temporary. Many side effects go away after the study eye
drops is stopped but, in some cases, the side effects may be serious and/or
lasting. Common side effects are listed below but they will vary from person
to person.
Vision may be temporarily blurred when these products are first used. Minor eye
pain, eye redness, burning, stinging, irritation, watery eyes, unpleasant taste
in the mouth and change in vision may temporarily occur. One may also
experience continued eye redness and irritation.
Administration of the study drug and/or the examination dyes, like any
medication, may cause an allergic reaction. Allergic reactions may be mild
(rash, hives) to severe (difficulty breathing, or a collapse of blood
circulation and breathing systems). A severe allergic reaction would require
immediate medical treatment and could result in permanent disability or death.
Rijksweg 14
Puurs B2870
BE
Rijksweg 14
Puurs B2870
BE
Listed location countries
Age
Inclusion criteria
1. Willing and able to attend all study visits
2. Must have all of the following in at least 1 eye at Screening (Day -15):
a. Meibomian Gland Dysfunction (MGD) grading for Expressibility * 2 and Meibum Quality * 2,
b. The average of 3 measures of TFBUT < 5 seconds, and
c. Unanesthetized Schirmer I test of * 3 mm
3. Must have an Ocular Surface Disease Index (OSDI) Score * 18 at Visit 1 (Day 0) prior to randomization (ie, after 2 weeks of run-in with Preservative-Free 0.9% Saline administered 4 times a day)
4. Must have best-corrected visual acuity of 55 letters or better in each eye as assessed using an ETDRS chart (letter read method)
5. Physician diagnosis of dry eye at least 6 months prior to Screening visit
6. Must be at least 18 years old and able to provide written informed consent
Exclusion criteria
1. Subjects on topical ocular treatments containing benzalkonium chloride (BAK), or other products with known toxicity to the corneal surface, within 30 days of Screening
2. Subjects who have started, stopped, or changed a lid hygiene regimen within 30 days of Screening. Note: Subjects who have been on a consistent lid hygiene regimen (ie, no change to the type of lid hygiene therapy that is being used as well as the frequency of use) for at least 30 days prior to Screening are not excluded. However, they cannot stop or change this regimen for the
duration of the study. In addition, subjects who do not currently use lid hygiene therapy cannot start for the duration of the study.
3. Use of any artificial tears/lubricants/gels/rewetting drops within 4 hours of Screening
4. Women of childbearing potential (those who are not surgically sterilized or postmenopausal for at least 2 years) are excluded from participating in this study if they meet any of the following conditions:
* They are currently pregnant, or
* Test positive for pregnancy at Screening visit, or
* They are currently breast feeding, or
* Are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study
5. Hypersensitivity to the use of any of the study products or allergy to any ingredient in the study products
6. Has an active ocular allergy
7. Ocular abnormalities that could adversely affect the safety or efficacy outcome such as:
* Eyelid anomalies that affect proper lid closure or proper blink function (eg, ectropion, entropion,
trichiasis, lid margin lesions, tarsal plate pathology, unresolved Bell*s palsy, etc.)
* Evidence of benign hemifacial spasm, benign essential blepharospasm, or eyelid apraxia
* Corneal disorders or abnormality such as active corneal ulcer, current corneal abrasion, keratoconus or corneal dystrophies which are actively changing or affect vision
* Metaplasia of the ocular surface
* History of corneal erosion syndrome or recurrent corneal erosion syndrome
* Clinically significant corneal epithelial anterior membrane dystrophy (subjects with
minor/insignificant predominantly peripheral corneal epithelial dystrophy [not central dystrophy] without a history of corneal erosion syndrome can be included)
* Current filamentous keratitis
* Evidence of corneal neovascularization
* Any history of Herpes Simplex or Herpes Zoster Keratitis
8. Subjects taking any systemic medication known to cause dry eye (eg, anti-histamines, anti-depressants, antipsychotics, etc.) unless they have been on stable therapy/dosage for at least 30 days prior to Screening and will remain on a stable dosage for the duration of the study
9. Subjects with a history of any ocular or intraocular surgery (including periocular Botox injections), eyelid surgery, keratorefractive procedure, corneal transplant and its variants (eg, penetrating keratoplasty, DSEK, DMEK, DSAEK, DALK), or serious ocular trauma within 1 year of Screening
10. Active ocular infection (bacterial, viral or fungal), active inflammation not associated with dry eye such as uveitis, iritis, active blepharitis, active allergic conjunctivitis, etc
11. Subjects with punctal plug insertion or diathermy procedure initiated within 30 days of Screening
12. Have any significant illnesses that could, in the opinion of the Investigator, be expected to interfere with the study parameters
13. Subjects with active oculodermal rosacea with meibomian gland dysfunction
14. Have participated in an investigational drug or device trial within 30 days of Screening
15. Contact lens use within 30 days prior to Screening, or unwilling to avoid contact lens use during the course of the study
16. Unwilling to avoid the use of additional artificial tears/lubricants/gels/rewetting drops (other than the assigned study medication) throughout the course of the study (including the run-in period)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01967147 |
| CCMO | NL46716.018.13 |