Clinical Effects and Safety of 3% Diquafosol After Cataract Surgery
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|ClinicalTrials.gov Identifier: NCT02608489|
Recruitment Status : Completed
First Posted : November 18, 2015
Results First Posted : October 17, 2016
Last Update Posted : October 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Syndromes||Drug: Diquafosol (Diquas) Drug: Sodium Hyaluronate (Hyalein)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Effects and Safety of 3% Diquafosol Ophthalmic Solution for Patients With Dry Eye After Cataract Surgery: A Randomized Controlled Trial|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Active Comparator: Diqufosol
3% Diquafosol Tetrasodium Ophthalmic Solution
Drug: Diquafosol (Diquas)
Diquafosol group used diquafosol 6 times a day during study period.
Placebo Comparator: Hyaluronate
0.1% Sodium Hyaluronate Ophthalmic Solution
Drug: Sodium Hyaluronate (Hyalein)
Hyaluronate group used sodium hyaluronate 6 times a day during study period.
- an Ocular Surface Disease Index (OSDI) Questionnaire That is Related to Dry Eye Severity. [ Time Frame: 12 weeks ]The OSDI questionnaire consists of 12 questions that evaluate subjective symptoms related to dry eye and vision The score ranges were between 0 and 100 scores and the higher scores represent a worse outcome.
- Schirmer I Test Without Anesthesia That is Related to Dry Eye Severity. [ Time Frame: 12 weeks ]Schirmer paper strips were placed into the temporal one third of the lower conjunctival sac for 5 min and the wetness on the strips was measured.
- Changes in HOAs After Blinking That is Related to Dry Eye Severity. [ Time Frame: 12 weeks ]Corneal HOAs and serial measurement of ocular total HOAs were evaluated using a KR-1W wavefront analyzer (Topcon Medical System, Inc., Tokyo, Japan). Serial measurement of total ocular HOAs was measured every second for 10 s after complete blinking in continuous measurement mode. The difference between the fifth and first HOA was used to evaluate the tear film instability.
- Tear Break-up Time (TBUT) That is Related to Dry Eye Severity. [ Time Frame: 12 weeks ]TBUT was assessed by instillation of a drop of 2% sterile fluorescein into the conjunctival sac and recording the interval between the last complete blink and the first appearance of a dry spot or disruption of the tear film.
- Corneal Fluorescein Staining That is Related to Dry Eye Severity. [ Time Frame: 12 weeks ]
Ocular surface damage was assessed by the National Eye Institute (NEI) workshop grading system, and corneal fluorescein staining was evaluated. Instillation of fluorescein in both eyes. After 1 or 2 full blinks, the intensity of staining of both cornea was scored. According to the National Eye Institute (NEI) workshop grading system, the cornea was divided into five sections. The minimum staining score was 0 and the maximum staining score was 15 points (up to 3 points for each section).
0 : best score (no corneal damage) 15 : worst score (severe corneal damages)
- Lissamine Green (LG) Conjunctival Staining That is Related to Dry Eye Severity [ Time Frame: 12 weeks ]
Ocular surface damage was assessed by the National Eye Institute (NEI) workshop grading system, and conjunctival LG staining were evaluated. Instillation of 1% lissamine green in both eyes. After 1 or 2 full blinks, the intensity of staining of both medial and lateral bulbar conjunctiva was cored. According to the National Eye Institute (NEI) workshop grading system, the conjunctiva was divided into six sections. The minimum staining score was 0 and the maximum staining score was 18 points (up to 3 points for each section).
0 : best score (no conjunctival damage) 18 : worst score (severe conjunctival damages)
- Grades of Anterior Chamber Cells. [ Time Frame: 12 weeks ]
Anterior chamber inflammation was examined with a slit-lamp clinically, and divided into six grades using the Standardization of Uveitis Nomenclature (SUN) working group grading scheme.
grade 0 : <1 cell in field, grade 0.5 : 1-5 cells in field, grade 1 : 6-15 cells in field, grade 2 : 16-25 cells in field grade 3 : 26-50 cells in field, grade 4 : >50 cells in field Field size is a 1 mm X 1 mm slit beam
- Number of Participants Who Stop Using the Eye Drops Due to Drug-related Discomfort [ Time Frame: 12 weeks ]Drug-related discomfort is defined as having started after eye drop instillation and lasting several minutes, occurring every time during instillation at any time up to 12 weeks into the follow-up period. Patients that had any adverse events or wanted to stop using the eye drops were excluded from the study, but these patients were included in the safety evaluation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608489
|Principal Investigator:||Jin Kwon Chung, MD||Soonchunhyang University Hospital|