Contact Lens Discomfort, Meibomian Gland Dysfunction
Conditions
Brief summary
The purpose of this study is to compare electronic debridement of the eyelid margin (BlephEx) to manual debridement of the eyelid margin as treatment options for patients intolerant to contact lens wear consequent to Meibomian gland dysfunction.
Interventions
DEVICEBlephEx
Electronic lid margin debridement
DEVICEManual debridement
Manual lid margin debridement
Sponsors
American Academy of Optometry
University of the Incarnate Word
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Habitual contact lens wearers whose contact lens wear time has reduced due to MGD will be preferentially considered for this study. Subjects who currently cannot wear contact lenses due to MGD may be considered on a case-by-case basis.
Exclusion criteria
* Subjects who are currently using any prescription ophthalmic medications (such as antibiotics, steroids and immunomodulatory drugs) will be excluded from participation. * Subjects who have active ocular infections will be excluded from participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic relief | 60 days | Betterment of symptoms (improvement in contact lens discomfort) will be measured using two different surveys - Ocular Surface Disease Index (OSID) and Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8). The OSDI scores can range from 0 to 100. The CLDEQ-8 scores can range from 0 to 37. In both the questionnaires, a lowering of the score during follow-up visits represents a betterment of symptoms suffered by the patient. The numerical change in the scores on these two questionnaires will be documented as the change in symptom profile of the patient (betterment / worsening / stability). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Meibography | 60 days | Meibomian gland imaging will be performed to document any changes in the Meibomian gland during the study period. |
| Lissamine green staining grade of the lid margin | 60 days | The lid margin will be stained with Lissamine green dye. For the purpose of this study, Lissamine green staining of the eyelid margins will be graded from 0 to 4. (Zero representing normal or no staining; Four representing the highest degree of staining). During the course of the study, a decrease in lid margin staining will indicate a betterment of the health of the eyelid margin. |
| Inflammatory activity | 60 days | The presence or absence of Matrix Metalloproteinase-9 (MMP-9) in the tear fluid will be documented during the study visits. Presence of MMP-9 in the tear fluid indicates the presence of inflammatory activity in the tear fluid. |
| Tear break-up time | 60 days | Improvement in non-invasive tear break-up time measurement will be an objective outcome of the study. |
Countries
United States
Outcome results
None listed