The purpose of this study is to assess long-term ocular safety of fluticasone furoate nasal spray in adult and adolescent subjects diagnosed with perennial allergic rhinitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
550
fluticasone furoate nasal spray
placebo
Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)
An event for P (opacity in the lens positioned just anterior to the posterior lens capsule and characterized by the posterior migration of lens epithelial cells from the lens bow) is defined as an increase of \>=0.3 from baseline in Lens Opacities Classification System, Version III (LOCS III; system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for P (range=0.1 \[lens clear\] to 5.9 \[lens unclear\]), in either eye. Data represent the Kaplan-Meier estimate for the CU of par. with an event of P based on a lifetest table.
Time frame: Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104
Cumulative Proportion of Participants, as Measured as a Percentage, With an Intraocular Pressure (IOP) Event
An event for IOP is defined as an increase of 7 millimeters of mercury (mm Hg) or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry (GAT). GAT is a commonly used method of determining approximate intraocular pressure. The data below represent the Kaplan-Meier estimate for the cumulative proportion of participants with an IOP event based on a lifetest table.
Time frame: Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104
Change From Baseline in LOCS III Posterior Subcapsular Opacity at Week 52 and Week 104
An event for P (opacity in the lens positioned just anterior to the posterior lens capsule and characterized by the posterior migration of lens epithelial cells from the lens bow) is defined as an increase of \>=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for P (range=0.1 \[lens clear\] to 5.9 \[lens unclear\]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.
Time frame: Baseline, Week 52, and Week 104
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GSK Investigational Site
Oxford, Alabama, United States
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Fresno, California, United States
GSK Investigational Site
Huntington Beach, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Mission Viejo, California, United States
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Rolling Hills Estates, California, United States
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Roseville, California, United States
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Sacramento, California, United States
GSK Investigational Site
San Diego, California, United States
...and 46 more locations
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
An event for P is defined as an increase of \>=0.3 from baseline in LOCS III (classification system based on standard color photographic transparencies) grade for P (range=0.1 \[lens clear\] to 5.9 \[lens unclear\]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.
Time frame: Baseline, Week 52, and Week 104
Change From Baseline in LOCS III Cortical Opacity (C) at Week 52 and Week 104
An event for C (an opacity starting at the outer edge of the lens and progressing toward the center) is defined as an increase of \>=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for C (range=0.1 \[lens clear\] to 5.9 \[lens unclear\]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.
Time frame: Baseline, Week 52, and Week 104
Number of Participants With the Indicated Change From Baseline in Cortical Opacity by Increment Categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104
An event for C (an opacity starting at the outer edge of the lens and progressing toward the center) is defined as an increase of \>=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for C (range=0.1 \[lens clear\] to 5.9 \[lens unclear\]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.
Time frame: Baseline, Week 52, and Week 104
Change From Baseline in LOCS III Nuclear Opacity (NO) at Week 52 and Week 104
Nuclear opacity refers to the opacity in the central nucleus of the eye.The range for NO is 0.1 (no opacity) to 6.9 (maximum opacity). Change from baseline in NO was calculated by subtracting the baseline value from the Week 52 or Week 104 value.
Time frame: Baseline, Week 52, and Week 104
Change From Baseline in Nuclear Color (NC) at Week 52 and Week 104
Nuclear color is associated with the force required to compress a lens to 75% of its original depth. The range for NC is 0.1 (no opacity) to 6.9 (maximum opacity). Change from baseline in NC was calculated by subtracting the baseline value from the Week 52 or Week 104 value.
Time frame: Baseline, Week 52, and Week 104
Change From Baseline in Intraocular Pressure (IOP) at Weeks 52 and 104
An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline was calculated by subtracting the baseline value from the Week 52 or Week 104 value.
Time frame: Baseline, Week 52, and Week 104
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline was calculated by subtracting the baseline value from the Week 52 value.
Time frame: Baseline and Week 52
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline in IOP was calculated by subtracting the baseline value from the Week 104 value.
Time frame: Baseline and Week 104
Change From Baseline in Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity (VA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts at Week 52 and Week 104
ETDRS charts are used to measure VA (the ability to resolve fine image details). Participants must have had a best-corrected distance VA of =\< 0.18 on the LogMAR scale using ETDRS charts in both eyes measured separately. The LogMAR scale (expressed as the \[decadic\] logarithm of the minimum angle of resolution \[range from +1.00 to -0.30\]) converts the geometric sequence of a traditional chart to a linear scale. It measures VA loss; positive values indicate vision loss, whereas negative values denote normal or better VA. A lower LogMAR value indicates better VA.
Time frame: Baseline, Week 52, and Week 104
Percent Change From Baseline in the Funduscopic Horizontal Cup-to-disc Ratio at Week 104
The funduscopic horizontal cup-to-risk ratio assesses the progression of glaucoma. Percent change from baseline in funduscopic horizontal cup-to-disc ratio at Week 104 was calculated by substracting the baseline value from the Week 104 value (both expressed as a percent). The cup-to-disc ratio compares the diameter of the "cup" portion of the optic disc with the total diameter of the optic disc. A large cup-to-disc ratio may imply glaucoma or other pathology.
Time frame: Baseline and Week 104
Change From Baseline in the Daily Reflective Total Nasal Symptom Score (rTNSS) for the Indicated Study Periods
rTNSS was evaluated on a 4-point categorical scale (sum of the scores for rhinorrhea, nasal congestion, nasal itching, and sneezing; range=0-12). The data collected were used as a measure for treatment compliance. The scores on the scale were based on the severity of each nasal symptom: 0=none (symptom is not present); 1=mild (sign/symptom is clearly present but minimal awareness; easily tolerated); 2=moderate (definite awareness of sign/symptom that is bothersome but tolerable); 3=severe (sign/symptom is hard to tolerate; causes interference with activities of daily living and/or sleeping).
Time frame: Baseline, Weeks 1 to 26, Weeks 27 to 52, Weeks 53 to 78, and Weeks 79 to 104