Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the repeated use of SYSTANE® BALANCE on stabilizing the tear film of dry eye patients with an unstable tear film.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SYSTANE BALANCE SYSTANE® BALANCE eyedrops, 1 drop 4 times a day for a continuous period of 1 month |
Other: SYSTANE® BALANCE eyedrops
|
| Active Comparator: Minims Saline Minims® Saline 0.9% eyedrops, 1 drop 4 times a day for a continuous period of 1 month |
Other: Minims® Saline 0.9% eyedrops
|
Outcome Measures
Primary Outcome Measures
- Mean Bulbar Conjunctival Staining [Month 1]
The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.
Secondary Outcome Measures
- High Contrast logMAR Time Controlled Visual Acuity (TCVA) [Month 1]
TCVA (functional visual performance) was measured with both eyes together under controlled lighting, contrast and temporal conditions using the OTG computerized vision testing system prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation with the subject's up-to-date vision correction in place. TCVA is measured in logarithm of the minimum angle of resolution (logMAR), with logMAR acuity of 0.0 considered normal distance eyesight. A negative logMAR value denotes better visual acuity.
- Non Invasive Tear Film Break-up-time (NIBUT) [Month 1]
NIBUT was measured prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation. The time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film as observed with a specialized illumination source was recorded. A higher number represents a lengthening in the tear film break up time and greater perceived ocular comfort.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Non-contact lens wearer;
-
Symptomatology as defined by the Ocular Surface Disease Index (OSDI) questionnaire;
-
Lipid deficiency;
-
Best visual acuity of 6/9 or better in each eye;
-
Willingness to adhere to the instructions set in the clinical protocol;
-
Signature of the subject informed consent form;
-
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
-
Use of systemic medication which might produce dry eye side effects;
-
Systemic disease which might produce dry eye side effects;
-
Active or recent ocular inflammation or infection;
-
Use of ocular medication;
-
Significant ocular anomaly;
-
Previous ocular surgery;
-
Previous use of Restasis;
-
Any medical condition that might be prejudicial to the study;
-
Pregnant or lactating;
-
Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Alcon Research
Investigators
- Principal Investigator: Michel Guillon, PhD, FCOptom, FAAO, CCTI, OTG Research & Consultancy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A00977
Study Results
Participant Flow
| Recruitment Details | Participants were recruited from 1 clinical site located in the UK. |
|---|---|
| Pre-assignment Detail | A total of 91 participants were enrolled and randomized. This reporting group includes all randomized participants (91). |
| Arm/Group Title | SYSTANE BALANCE | Minims Saline |
|---|---|---|
| Arm/Group Description | One drop 4 times a day for a continuous period of 1 month | One drop 4 times a day for a continuous period of 1 month |
| Period Title: Overall Study | ||
| STARTED | 46 | 45 |
| COMPLETED | 45 | 44 |
| NOT COMPLETED | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | SYSTANE BALANCE | Minims Saline | Total |
|---|---|---|---|
| Arm/Group Description | One drop 4 times a day for a continuous period of 1 month | One drop 4 times a day for a continuous period of 1 month | Total of all reporting groups |
| Overall Participants | 46 | 45 | 91 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
46.8
(16.51)
|
44.6
(14.84)
|
45.7
(15.66)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
30
65.2%
|
29
64.4%
|
59
64.8%
|
| Male |
16
34.8%
|
16
35.6%
|
32
35.2%
|
Outcome Measures
| Title | Mean Bulbar Conjunctival Staining |
|---|---|
| Description | The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome. |
| Time Frame | Month 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment. |
| Arm/Group Title | SYSTANE BALANCE | Minims Saline |
|---|---|---|
| Arm/Group Description | One drop 4 times a day for a continuous period of 1 month | One drop 4 times a day for a continuous period of 1 month |
| Measure Participants | 45 | 44 |
| Right eye |
0.743
(1.685)
|
0.442
(0.999)
|
| Left eye |
0.531
(1.056)
|
0.443
(1.404)
|
| Title | High Contrast logMAR Time Controlled Visual Acuity (TCVA) |
|---|---|
| Description | TCVA (functional visual performance) was measured with both eyes together under controlled lighting, contrast and temporal conditions using the OTG computerized vision testing system prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation with the subject's up-to-date vision correction in place. TCVA is measured in logarithm of the minimum angle of resolution (logMAR), with logMAR acuity of 0.0 considered normal distance eyesight. A negative logMAR value denotes better visual acuity. |
| Time Frame | Month 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment. |
| Arm/Group Title | SYSTANE BALANCE | Minims Saline |
|---|---|---|
| Arm/Group Description | One drop 4 times a day for a continuous period of 1 month | One drop 4 times a day for a continuous period of 1 month |
| Measure Participants | 45 | 44 |
| Baseline |
0.220
(1.105)
|
0.253
(0.100)
|
| 60 minutes |
0.206
(1.106)
|
0.295
(0.840)
|
| 90 minutes |
0.240
(1.124)
|
0.202
(0.826)
|
| 120 minutes |
0.293
(1.090)
|
0.206
(0.973)
|
| Title | Non Invasive Tear Film Break-up-time (NIBUT) |
|---|---|
| Description | NIBUT was measured prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation. The time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film as observed with a specialized illumination source was recorded. A higher number represents a lengthening in the tear film break up time and greater perceived ocular comfort. |
| Time Frame | Month 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment. Here, n represents the number of participants with non-missing values at the specific time point for each arm group, respectively. |
| Arm/Group Title | SYSTANE BALANCE/Right Eye | SYSTANE BALANCE/Left Eye | Minims Saline/Right Eye | Minims Saline/Left Eye |
|---|---|---|---|---|
| Arm/Group Description | One drop 4 times a day for 1 month | One drop 4 times a day for 1 month | One drop 4 times a day for 1 month | One drop 4 times a day for 1 month |
| Measure Participants | 45 | 45 | 44 | 44 |
| Baseline (n=44,44) |
9.39
(7.68)
|
7.47
(7.38)
|
9.53
(13.19)
|
7.66
(8.32)
|
| 60 minutes (n=44,43) |
7.81
(10.17)
|
8.74
(10.42)
|
8.17
(10.45)
|
6.96
(6.16)
|
| 90 minutes (n=44,43) |
8.41
(9.55)
|
7.59
(9.64)
|
7.31
(8.33)
|
6.97
(5.39)
|
| 120 minutes (n=44,43) |
6.92
(6.52)
|
7.26
(6.71)
|
8.63
(10.08)
|
6.16
(6.59)
|
Adverse Events
| Time Frame | Adverse events (AEs) were collected for the duration of the study (Dec2012 to Nov2013). This analysis population includes all subjects who were randomized into the study, used at least 1 eye drop, and completed at least 1 post-treatment safety assessment. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device. | |||
| Arm/Group Title | SYSTANE BALANCE | Minims Saline | ||
| Arm/Group Description | One drop 4 times a day for a continuous period of 1 month | One drop 4 times a day for a continuous period of 1 month | ||
All Cause Mortality |
||||
| SYSTANE BALANCE | Minims Saline | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| SYSTANE BALANCE | Minims Saline | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/46 (2.2%) | 1/45 (2.2%) | ||
| Infections and infestations | ||||
| Blood poisoning | 1/46 (2.2%) | 0/45 (0%) | ||
| Surgical and medical procedures | ||||
| Knee operation | 0/46 (0%) | 1/45 (2.2%) | ||
Other (Not Including Serious) Adverse Events |
||||
| SYSTANE BALANCE | Minims Saline | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/46 (0%) | 0/45 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
| Name/Title | Abayomi Ogundele, Global Brand Medical Affairs Lead |
|---|---|
| Organization | Alcon Research, Ltd. |
| Phone | 1-888-451-3937 |
| alcon.medinfo@alcon.com |
- A00977