This study compares patient symptoms and anterior segment safety in patients treated with timolol hemihydrate, generic timolol gel forming solution or timolol maleate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
0.5%
0.5%
Unnamed facility
Bourbonnais, Illinois, United States
Unnamed facility
Charlotte, North Carolina, United States
Stinging on Instillation
Assessed from subject response to survey question asking about tolerability of medicine upon instillation, using a 0 through 7 scale, with 0=complete comfort and 7=worst pain imaginable.
Time frame: following 3 days of treatment
Conjunctival Hyperemia
Assessed by investigator using a slit lamp and a photographic grading scale. Photographs were graded: grade 0, grade 1, grade 2, grade 3. The higher the graded the worse the hyperemia.
Time frame: following 3 days of treatment
Tear Film Break-up Time
Time frame: following 3 days of treatment
Corneal Staining Grade
Assessed by the investigator using a slit lamp and Oxford Scheme, grading 0,1,2,3,4,5. The higher the grade the worse the staining.
Time frame: following 3 days of treatment
Corneal Staining Count
Assessed by the investigator using a slit lamp, counting the number of spots.
Time frame: following 3 days of treatment
Intraoclular Pressure
Time frame: following 3 days of treatment
Basic Schirmer's
Schirmer's measures basic tear function. The higher the number, the less dry the eye.
Time frame: following 3 days of treatment
Conjunctival Staining - Nasal Grade
Assessed by investigator using a slit lamp and the Oxford Scheme, grading 0,1,2,3,4,5 according to pictures provided. The higher the grade the worse the staining.
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Time frame: following 3 days of treatment
Conjunctival Staining - Nasal Count
Assessed by investigator using slit lamp and counting number of spots.
Time frame: following 3 days of treatment
Conjunctival Staining - Temporal Grade
Assessed by investigator using a slit lamp and Oxford Scheme, grading 0,1,2,3,4,5 according to pictures provided. The higher the grade the worse the staining.
Time frame: following 3 days of treatment
Conjunctival Staining - Temporal Count
Assessed by investigator using a slit lamp and counting number of spots.
Time frame: following 3 days of treatment
Visual Acuity
The visual acuity score is a count of the number of letters the subject successfully read from the eye chart. The higher the score, the better the vision.
Time frame: following 3 days of treatment