Phase 4
N=180
A Study of Sodium Carboxymethylcellulose for Post Cataract Surgery Dry Eye Symptoms
Dry Eye Syndromes · Cataract
Bottom Line
View on ClinicalTrials.gov: NCT02028754 ↗Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Tear Break-Up Time (TBUT) in the Study Eye — 8.5; 6.6 Seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sodium Carboxymethylcellulose (Drug); Levofloxacin (Drug); Prednisolone (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tear Break-Up Time (TBUT) in the Study Eye |
9.0; 6.7 | — |
| PRIMARY Tear Break-Up Time (TBUT) in the Study Eye |
9.0; 6.7 | — |
| SECONDARY Fluorescein Staining Score in the Study Eye |
2.0; 1.8; 1.1; 1.2 | — |
| SECONDARY Lissamine Green Staining Score in the Study Eye |
2.9; 2.6; 2.1; 2.3 | — |
| SECONDARY Results of Schirmer I Test With Anesthetics in the Study Eye |
11.8; 12.5; 12.7; 12.6 | — |
| SECONDARY Ocular Surface Disease Index (OSDI) Questionnaire Score in the Study Eye |
15.6; 18.1; 12.7; 14.2 | — |
| SECONDARY Subjective Symptom Total Score in the Study Eye |
6.1; 6.4; 5.1; 5.6 | — |
Summary
This study will evaluate the effect of sodium carboxymethylcellulose eye drops in the treatment of dry eye after cataract surgery.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of age-related cataract in the study eye
- Scheduled for cataract surgery and lens implant
Exclusion Criteria
- Diagnosis of ocular surface disease or glaucoma
- Ocular surgery in the past 3 months
- Wearing a corneal contact lens in the study eye
Data sourced from ClinicalTrials.gov (NCT02028754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.