Cataract, Dry Eye Disease
Conditions
Brief summary
The primary objective of this study is to demonstrate reduced corneal staining with use of Systane Hydration among subjects with dry eye disease (DED) undergoing routine cataract removal and monofocal intraocular lens (IOL) implantation.
Detailed description
Subjects will attend 6 scheduled study visits for an individual duration of participation of 6 weeks. One eye (study eye) will be followed.
Interventions
Sterile solution indicated for the temporary relief of burning and irritation due to dryness of the eye
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Seeking routine (age-related) cataract extraction with monofocal intraocular lens implantation; * Able to provide informed consent; * Willing and able to attend all study visits and comply with treatment; * Have dry eyes per dry eye questionnaire. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Subjects who use of ocular drugs, other than the test article (for treatment group only) and other standard of care postoperative medications, during the study; * History of intraocular or corneal surgery in the study eye; * Use of artificial tears, steroids, or other medications as specified in the protocol; * Clinically significant corneal scarring; * Corneal degeneration, retinal degeneration or other ocular pathology as specified in the protocol. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal staining | Up to Day 30 post-operative | The National Eye Institute (NEI) grading scale will be used to evaluate the five corneal regions: Superior, inferior, central, temporal and nasal. Each region will be graded on a 0-3 scale, where 0 = normal (no staining), 1 = mild/superficial stippling micropunctate staining, 2 = moderate/macropunctate staining with some coalescent areas, and 3 = severe/numerous coalescent macropunctate areas and/or patches. The regions will be summed for a resultant overall score of 0 to 15. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DEQ-5 Score | Up to Day 30 post-operative | The Dry Eye Questionnaire-5 (DEQ-5) is a patient-reported outcome measures questionnaire designed to assess symptoms of dry eye disease. Subjects will respond to 5 questions using a 0-4 Likert-type scale, for a resultant overall score of 0 (best) to 20 (worst). |
| Ocular Comfort Questionnaire Score: My eyes are comfortable | Up to Day 30 post-operative | Subjects will provide a comfort score (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) to the following question: My eyes are comfortable. |
| Ocular Comfort Questionnaire Score: At the end of the day, my eyes feel comfortable | Up to Day 30 post-operative | Subjects will provide a comfort score (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) to the following question: At the end of the day, my eyes feel comfortable. |
| Ocular Comfort Questionnaire Score: My eyes are comfortable all day long | Up to Day 30 post-operative | Subjects will provide a comfort score (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) to the following question: My eyes are comfortable all day long. |
Countries
Spain
Outcome results
None listed