Dry Eye Syndromes, Keratoconjunctivitis Sicca
Conditions
Brief summary
This study will evaluate the safety and efficacy of OPTIVE® MD for ocular surface integrity in symptomatic dry eye condition in absence of obvious eye-lid inflammation.
Interventions
DRUGcarboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD)
One drop in each eye three to six times daily, as needed
DRUGsodium hyaluronate 0.18% (VISMED® Multi)
One drop in each eye three to six times daily, as needed
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have been using artificial tears for at least 3 months prior to study inclusion * Have been using preservative free artificial tears at least three times daily (TIB) for at least 2 weeks immediately prior to study inclusion * Having moderate to severe symptoms suggestive of dry eye
Exclusion criteria
* Current enrollment in an investigational drug or device study or participation in such a study within 3 months prior to entry into this study * Moderate to severe blepharitis * History or active signs of ocular trauma, ocular infection, or ocular inflammation within the last 3 months * History or active signs of ocular allergic disease or ocular herpes within the last year * History or active signs of severe or serious ocular conditions such as inflammatory corneal ulcers, recurrent erosions, and uveitis at any time.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Global Ocular Staining Score at Day 35 | Baseline, Day 35 | Change from baseline in global ocular staining score (range from 0-15) at Day 35. The global ocular staining score is the sum of three different staining severities, each with a score of 0-5 on a 6-point scale, where 0 is no staining (best) and 5 is diffuse staining (worst). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35 | Baseline, Day 35 | Change from baseline in Ocular Surface Disease Index (OSDI) questionnaire score at Day 35. The OSDI questionnaire consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (where 0=none of the time and 4=all of the time). The score is converted to a 0-100 point score where 0 is no symptoms and 100 is most symptoms. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD) carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD) | 41 |
| Sodium Hyaluronate 0.18% (VISMED® Multi) sodium hyaluronate 0.18% (VISMED® Multi) | 41 |
| Total | 82 |
Baseline characteristics
| Characteristic | Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD) | Sodium Hyaluronate 0.18% (VISMED® Multi) | Total |
|---|---|---|---|
| Age, Customized <65 years | 22 participants | 29 participants | 51 participants |
| Age, Customized >=65 years | 19 participants | 12 participants | 31 participants |
| Sex: Female, Male Female | 36 Participants | 38 Participants | 74 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 41 | 0 / 38 |
| serious Total, serious adverse events | 1 / 41 | 1 / 38 |
Outcome results
Primary
Change From Baseline in Global Ocular Staining Score at Day 35
Change from baseline in global ocular staining score (range from 0-15) at Day 35. The global ocular staining score is the sum of three different staining severities, each with a score of 0-5 on a 6-point scale, where 0 is no staining (best) and 5 is diffuse staining (worst).
Time frame: Baseline, Day 35
Population: Per Protocol: All subjects who were randomised, who received at least one dose of the study product, had at least one follow-up visit and who did not have significant protocol violations and who completed the assessment of this outcome measure at Day 35.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD) | Change From Baseline in Global Ocular Staining Score at Day 35 | Baseline | 5.4 Number on a scale (score) | Standard Deviation 1.59 |
| Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD) | Change From Baseline in Global Ocular Staining Score at Day 35 | Day 35 | -1.8 Number on a scale (score) | Standard Deviation 1.95 |
| Sodium Hyaluronate 0.18% (VISMED® Multi) | Change From Baseline in Global Ocular Staining Score at Day 35 | Baseline | 5.9 Number on a scale (score) | Standard Deviation 1.47 |
| Sodium Hyaluronate 0.18% (VISMED® Multi) | Change From Baseline in Global Ocular Staining Score at Day 35 | Day 35 | -1.8 Number on a scale (score) | Standard Deviation 2.3 |
Secondary
Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35
Change from baseline in Ocular Surface Disease Index (OSDI) questionnaire score at Day 35. The OSDI questionnaire consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (where 0=none of the time and 4=all of the time). The score is converted to a 0-100 point score where 0 is no symptoms and 100 is most symptoms.
Time frame: Baseline, Day 35
Population: Per Protocol: All subjects who were randomised, who received at least one dose of the study product, had at least one follow-up visit and who did not have significant protocol violations and who completed the assessment of this outcome measure at Day 35.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD) | Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35 | Baseline | 49.05 Number on a scale (score) | Standard Deviation 17.06 |
| Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD) | Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35 | Day 35 | -13.58 Number on a scale (score) | Standard Deviation 19.047 |
| Sodium Hyaluronate 0.18% (VISMED® Multi) | Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35 | Baseline | 51.98 Number on a scale (score) | Standard Deviation 18.164 |
| Sodium Hyaluronate 0.18% (VISMED® Multi) | Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35 | Day 35 | -13.66 Number on a scale (score) | Standard Deviation 16.542 |