Trial Outcomes & Findings for FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial (NCT NCT04149210)
NCT ID: NCT04149210
Last Updated: 2026-03-24
Results Overview
The primary outcome measure is the postoperative recurrence of trachomatous trichiasis (TT), defined as one or more eyelashes in the upper eyelid touching the globe or evidence of epilation (lash stubs) in the upper eyelid on examination, or a history of repeat trichiasis surgery at any time in the upper eyelid during the one year follow-up period after the baseline surgery.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2410 participants
Primary outcome timeframe
12 months
Results posted on
2026-03-24
Participant Flow
Participant milestones
| Measure |
Artificial Tears
Placebo comparator - one drop two times daily for four weeks
|
Fluorometholone
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
|---|---|---|
|
Overall Study
STARTED
|
1206
|
1204
|
|
Overall Study
COMPLETED
|
1181
|
1180
|
|
Overall Study
NOT COMPLETED
|
25
|
24
|
Reasons for withdrawal
| Measure |
Artificial Tears
Placebo comparator - one drop two times daily for four weeks
|
Fluorometholone
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
|---|---|---|
|
Overall Study
Death
|
6
|
8
|
|
Overall Study
Lost to Follow-up
|
14
|
14
|
|
Overall Study
Other
|
5
|
2
|
Baseline Characteristics
FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial
Baseline characteristics by cohort
| Measure |
Artificial Tears
n=1632 Study Eyes
Placebo comparator - one drop two times daily for four weeks
|
Fluorometholone
n=1603 Study Eyes
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
Total
n=3235 Study Eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.8 Years
STANDARD_DEVIATION 15.2 • n=138 Participants
|
47.3 Years
STANDARD_DEVIATION 14.9 • n=62 Participants
|
47.6 Years
STANDARD_DEVIATION 15.1 • n=123 Participants
|
|
Sex: Female, Male
Female
|
856 Participants
n=138 Participants
|
836 Participants
n=62 Participants
|
1692 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
350 Participants
n=138 Participants
|
368 Participants
n=62 Participants
|
718 Participants
n=123 Participants
|
|
Laterality of TT Surgery
Unilateral
|
779 Participants
n=138 Participants
|
803 Participants
n=62 Participants
|
1582 Participants
n=123 Participants
|
|
Laterality of TT Surgery
Bilateral
|
425 Participants
n=138 Participants
|
398 Participants
n=62 Participants
|
823 Participants
n=123 Participants
|
|
Laterality of TT Surgery
No surgery due to withdrawal after randomization
|
2 Participants
n=138 Participants
|
3 Participants
n=62 Participants
|
5 Participants
n=123 Participants
|
|
Reading ability: unable
|
1085 Participants
n=138 Participants
|
1082 Participants
n=62 Participants
|
2167 Participants
n=123 Participants
|
|
Self-reported pain or discomfort
None
|
335 Participants
n=138 Participants
|
316 Participants
n=62 Participants
|
651 Participants
n=123 Participants
|
|
Self-reported pain or discomfort
Slight
|
418 Participants
n=138 Participants
|
419 Participants
n=62 Participants
|
837 Participants
n=123 Participants
|
|
Self-reported pain or discomfort
Moderate
|
234 Participants
n=138 Participants
|
249 Participants
n=62 Participants
|
483 Participants
n=123 Participants
|
|
Self-reported pain or discomfort
Severe
|
182 Participants
n=138 Participants
|
169 Participants
n=62 Participants
|
351 Participants
n=123 Participants
|
|
Self-reported pain or discomfort
Extreme
|
37 Participants
n=138 Participants
|
51 Participants
n=62 Participants
|
88 Participants
n=123 Participants
|
|
Ocular Surface Disease Index (OSDI) ocular symptoms score
|
48.6 scores on a scale
STANDARD_DEVIATION 29.5 • n=138 Participants
|
48.5 scores on a scale
STANDARD_DEVIATION 29.9 • n=62 Participants
|
48.6 scores on a scale
STANDARD_DEVIATION 29.7 • n=123 Participants
|
|
Ocular Surface Disease Index (OSDI) total score
|
37.8 scores on a scale
STANDARD_DEVIATION 23.2 • n=138 Participants
|
37.9 scores on a scale
STANDARD_DEVIATION 23.4 • n=62 Participants
|
37.9 scores on a scale
STANDARD_DEVIATION 23.3 • n=123 Participants
|
|
Type of TT surgery
BLTR
|
524 Study Eyes
n=47 Study Eyes
|
515 Study Eyes
n=45 Study Eyes
|
1039 Study Eyes
n=47 Study Eyes
|
|
Type of TT surgery
PLTR
|
1105 Study Eyes
n=47 Study Eyes
|
1084 Study Eyes
n=45 Study Eyes
|
2189 Study Eyes
n=47 Study Eyes
|
|
Type of TT surgery
No surgery due to withdrawal after randomization
|
3 Study Eyes
n=47 Study Eyes
|
4 Study Eyes
n=45 Study Eyes
|
7 Study Eyes
n=47 Study Eyes
|
|
Presenting Visual Acuity
20/20
|
103 Study Eyes
n=47 Study Eyes
|
81 Study Eyes
n=45 Study Eyes
|
184 Study Eyes
n=47 Study Eyes
|
|
Presenting Visual Acuity
20/25 - 20/40
|
586 Study Eyes
n=47 Study Eyes
|
566 Study Eyes
n=45 Study Eyes
|
1152 Study Eyes
n=47 Study Eyes
|
|
Presenting Visual Acuity
20/50 - 20/63
|
438 Study Eyes
n=47 Study Eyes
|
466 Study Eyes
n=45 Study Eyes
|
904 Study Eyes
n=47 Study Eyes
|
|
Presenting Visual Acuity
20/80 - 20/160
|
344 Study Eyes
n=47 Study Eyes
|
321 Study Eyes
n=45 Study Eyes
|
665 Study Eyes
n=47 Study Eyes
|
|
Presenting Visual Acuity
20/200 - 20/400
|
88 Study Eyes
n=47 Study Eyes
|
92 Study Eyes
n=45 Study Eyes
|
180 Study Eyes
n=47 Study Eyes
|
|
Presenting Visual Acuity
Worse than 20/400
|
73 Study Eyes
n=47 Study Eyes
|
77 Study Eyes
n=45 Study Eyes
|
150 Study Eyes
n=47 Study Eyes
|
|
Total number of upper eyelid lashes touching the globe or the cornea
0 (epilating)
|
236 Study Eyes
n=47 Study Eyes
|
252 Study Eyes
n=45 Study Eyes
|
488 Study Eyes
n=47 Study Eyes
|
|
Total number of upper eyelid lashes touching the globe or the cornea
1-5
|
1058 Study Eyes
n=47 Study Eyes
|
1005 Study Eyes
n=45 Study Eyes
|
2063 Study Eyes
n=47 Study Eyes
|
|
Total number of upper eyelid lashes touching the globe or the cornea
6-9
|
143 Study Eyes
n=47 Study Eyes
|
178 Study Eyes
n=45 Study Eyes
|
321 Study Eyes
n=47 Study Eyes
|
|
Total number of upper eyelid lashes touching the globe or the cornea
10-19
|
152 Study Eyes
n=47 Study Eyes
|
130 Study Eyes
n=45 Study Eyes
|
282 Study Eyes
n=47 Study Eyes
|
|
Total number of upper eyelid lashes touching the globe or the cornea
20+
|
43 Study Eyes
n=47 Study Eyes
|
38 Study Eyes
n=45 Study Eyes
|
81 Study Eyes
n=47 Study Eyes
|
|
Mean total number of upper eyelid lashes touching the globe or the cornea
|
3.9 Upper lid lashes touching globe/cornea
STANDARD_DEVIATION 4.8 • n=47 Study Eyes
|
3.8 Upper lid lashes touching globe/cornea
STANDARD_DEVIATION 4.8 • n=45 Study Eyes
|
3.9 Upper lid lashes touching globe/cornea
STANDARD_DEVIATION 4.8 • n=47 Study Eyes
|
|
Evidence/extent of epilation in the upper eyelid
None
|
1386 Study Eyes
n=47 Study Eyes
|
1341 Study Eyes
n=45 Study Eyes
|
2727 Study Eyes
n=47 Study Eyes
|
|
Evidence/extent of epilation in the upper eyelid
<1/3 of the lid margin
|
39 Study Eyes
n=47 Study Eyes
|
30 Study Eyes
n=45 Study Eyes
|
69 Study Eyes
n=47 Study Eyes
|
|
Evidence/extent of epilation in the upper eyelid
≥ 1/3 to ≤ 2/3 of the lid margin
|
75 Study Eyes
n=47 Study Eyes
|
81 Study Eyes
n=45 Study Eyes
|
156 Study Eyes
n=47 Study Eyes
|
|
Evidence/extent of epilation in the upper eyelid
> 2/3 of the lid margin
|
132 Study Eyes
n=47 Study Eyes
|
151 Study Eyes
n=45 Study Eyes
|
283 Study Eyes
n=47 Study Eyes
|
|
Severity of upper eyelid trichiasis
Severe (total number of lashes ≥ 6, or epilation ≥ 1/3)
|
541 Study Eyes
n=47 Study Eyes
|
576 Study Eyes
n=45 Study Eyes
|
1117 Study Eyes
n=47 Study Eyes
|
|
Severity of upper eyelid trichiasis
Not severe
|
1091 Study Eyes
n=47 Study Eyes
|
1027 Study Eyes
n=45 Study Eyes
|
2118 Study Eyes
n=47 Study Eyes
|
|
Upper Eyelid Entropion
E0: None
|
176 Study Eyes
n=47 Study Eyes
|
168 Study Eyes
n=45 Study Eyes
|
344 Study Eyes
n=47 Study Eyes
|
|
Upper Eyelid Entropion
E1: Mild
|
642 Study Eyes
n=47 Study Eyes
|
598 Study Eyes
n=45 Study Eyes
|
1240 Study Eyes
n=47 Study Eyes
|
|
Upper Eyelid Entropion
E2: Moderate
|
466 Study Eyes
n=47 Study Eyes
|
439 Study Eyes
n=45 Study Eyes
|
905 Study Eyes
n=47 Study Eyes
|
|
Upper Eyelid Entropion
E3: Severe
|
246 Study Eyes
n=47 Study Eyes
|
287 Study Eyes
n=45 Study Eyes
|
533 Study Eyes
n=47 Study Eyes
|
|
Upper Eyelid Entropion
E4: Total
|
102 Study Eyes
n=47 Study Eyes
|
111 Study Eyes
n=45 Study Eyes
|
213 Study Eyes
n=47 Study Eyes
|
|
Conjunctivalization of the lid margin grade
CM0: None
|
25 Study Eyes
n=47 Study Eyes
|
16 Study Eyes
n=45 Study Eyes
|
41 Study Eyes
n=47 Study Eyes
|
|
Conjunctivalization of the lid margin grade
CM1: posterior to the line of meibomian gland
|
169 Study Eyes
n=47 Study Eyes
|
175 Study Eyes
n=45 Study Eyes
|
344 Study Eyes
n=47 Study Eyes
|
|
Conjunctivalization of the lid margin grade
CM2: less than 50% of the lid
|
627 Study Eyes
n=47 Study Eyes
|
589 Study Eyes
n=45 Study Eyes
|
1216 Study Eyes
n=47 Study Eyes
|
|
Conjunctivalization of the lid margin grade
CM3: greater than 50% of the lid
|
811 Study Eyes
n=47 Study Eyes
|
823 Study Eyes
n=45 Study Eyes
|
1634 Study Eyes
n=47 Study Eyes
|
|
Trichiasis of the lower eyelid
No
|
1571 Study Eyes
n=47 Study Eyes
|
1509 Study Eyes
n=45 Study Eyes
|
3080 Study Eyes
n=47 Study Eyes
|
|
Trichiasis of the lower eyelid
Yes
|
61 Study Eyes
n=47 Study Eyes
|
94 Study Eyes
n=45 Study Eyes
|
155 Study Eyes
n=47 Study Eyes
|
|
Corneal opacity
C0: None
|
1046 Study Eyes
n=47 Study Eyes
|
1004 Study Eyes
n=45 Study Eyes
|
2050 Study Eyes
n=47 Study Eyes
|
|
Corneal opacity
C1: Peripheral
|
357 Study Eyes
n=47 Study Eyes
|
376 Study Eyes
n=45 Study Eyes
|
733 Study Eyes
n=47 Study Eyes
|
|
Corneal opacity
C2a: Off center faint
|
75 Study Eyes
n=47 Study Eyes
|
79 Study Eyes
n=45 Study Eyes
|
154 Study Eyes
n=47 Study Eyes
|
|
Corneal opacity
C2b: Off center dense
|
16 Study Eyes
n=47 Study Eyes
|
12 Study Eyes
n=45 Study Eyes
|
28 Study Eyes
n=47 Study Eyes
|
|
Corneal opacity
C2c: Central faint
|
110 Study Eyes
n=47 Study Eyes
|
95 Study Eyes
n=45 Study Eyes
|
205 Study Eyes
n=47 Study Eyes
|
|
Corneal opacity
C2d: Central dense
|
18 Study Eyes
n=47 Study Eyes
|
24 Study Eyes
n=45 Study Eyes
|
42 Study Eyes
n=47 Study Eyes
|
|
Corneal opacity
C3: Total/central dense
|
10 Study Eyes
n=47 Study Eyes
|
13 Study Eyes
n=45 Study Eyes
|
23 Study Eyes
n=47 Study Eyes
|
|
Corneal opacity
C4: Phthisis
|
0 Study Eyes
n=47 Study Eyes
|
0 Study Eyes
n=45 Study Eyes
|
0 Study Eyes
n=47 Study Eyes
|
|
Upper eyelid conjunctival scarring
S0: None
|
86 Study Eyes
n=47 Study Eyes
|
69 Study Eyes
n=45 Study Eyes
|
155 Study Eyes
n=47 Study Eyes
|
|
Upper eyelid conjunctival scarring
S1: Mild
|
90 Study Eyes
n=47 Study Eyes
|
102 Study Eyes
n=45 Study Eyes
|
192 Study Eyes
n=47 Study Eyes
|
|
Upper eyelid conjunctival scarring
S2: Moderate
|
806 Study Eyes
n=47 Study Eyes
|
811 Study Eyes
n=45 Study Eyes
|
1617 Study Eyes
n=47 Study Eyes
|
|
Upper eyelid conjunctival scarring
S3: Severe
|
650 Study Eyes
n=47 Study Eyes
|
621 Study Eyes
n=45 Study Eyes
|
1271 Study Eyes
n=47 Study Eyes
|
|
IOP
|
12.0 mmHg
STANDARD_DEVIATION 3.2 • n=47 Study Eyes
|
11.9 mmHg
STANDARD_DEVIATION 3.2 • n=45 Study Eyes
|
11.9 mmHg
STANDARD_DEVIATION 3.2 • n=47 Study Eyes
|
|
Diagnosed with cataract: Yes
|
18 Study Eyes
n=47 Study Eyes
|
26 Study Eyes
n=45 Study Eyes
|
44 Study Eyes
n=47 Study Eyes
|
|
Previous eye surgery: Yes
|
7 Study Eyes
n=47 Study Eyes
|
7 Study Eyes
n=45 Study Eyes
|
14 Study Eyes
n=47 Study Eyes
|
|
Previous eye injury: Yes
|
23 Study Eyes
n=47 Study Eyes
|
27 Study Eyes
n=45 Study Eyes
|
50 Study Eyes
n=47 Study Eyes
|
|
Race/Ethnicity, Customized
African
|
1206 Participants
n=138 Participants
|
1204 Participants
n=62 Participants
|
2410 Participants
n=123 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Numbers analyzed may differ due to different number of patients that completed each follow up visit due to reasons such as death or lost to follow up.
The primary outcome measure is the postoperative recurrence of trachomatous trichiasis (TT), defined as one or more eyelashes in the upper eyelid touching the globe or evidence of epilation (lash stubs) in the upper eyelid on examination, or a history of repeat trichiasis surgery at any time in the upper eyelid during the one year follow-up period after the baseline surgery.
Outcome measures
| Measure |
Fluorometholone
n=1593 Study eyes
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
Artificial Tears
n=1625 Study eyes
Placebo comparator - one drop two times daily for four weeks
|
|---|---|---|
|
Incidence of Postoperative TT by One Year, as Determined by Trained Study Team Members
PTT at any time during one-year follow-up · PTT at any time during one-year follow-up
|
213 Study eyes
|
218 Study eyes
|
|
Incidence of Postoperative TT by One Year, as Determined by Trained Study Team Members
PTT present at 4 weeks · PTT at any time during one-year follow-up
|
36 Study eyes
|
32 Study eyes
|
|
Incidence of Postoperative TT by One Year, as Determined by Trained Study Team Members
PTT present at 6 months · PTT at any time during one-year follow-up
|
136 Study eyes
|
137 Study eyes
|
|
Incidence of Postoperative TT by One Year, as Determined by Trained Study Team Members
PTT present at 12 months · PTT at any time during one-year follow-up
|
167 Study eyes
|
168 Study eyes
|
|
Incidence of Postoperative TT by One Year, as Determined by Trained Study Team Members
Early-onset PTT (incident by the time of the 6-month visit) · PTT at any time during one-year follow-up
|
146 Study eyes
|
150 Study eyes
|
|
Incidence of Postoperative TT by One Year, as Determined by Trained Study Team Members
Late-onset PTT (incident after the 6-month visit) · PTT at any time during one-year follow-up
|
67 Study eyes
|
68 Study eyes
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Numbers analyzed may differ due to different number of patients that completed each follow up visit due to reasons such as death or lost to follow up.
Presence and extent of entropion of the upper eyelid
Outcome measures
| Measure |
Fluorometholone
n=1567 Study eyes
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
Artificial Tears
n=1600 Study eyes
Placebo comparator - one drop two times daily for four weeks
|
|---|---|---|
|
Efficacy Measure 1 - Entropion
|
234 Study eyes
|
208 Study eyes
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Numbers analyzed may differ due to different number of patients that completed each follow up visit due to reasons such as death or lost to follow up.
Number of study eyes undergoing reoperation for postoperative trichiasis
Outcome measures
| Measure |
Fluorometholone
n=1593 Study eyes
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
Artificial Tears
n=1625 Study eyes
Placebo comparator - one drop two times daily for four weeks
|
|---|---|---|
|
Efficacy Measure 2 - Reoperation
|
3 Study eyes
|
1 Study eyes
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Numbers analyzed may differ due to different number of patients that completed each follow up visit due to reasons such as death or lost to follow up.
Number and location of trichiatic lashes from the upper eyelid touching the globe
Outcome measures
| Measure |
Fluorometholone
n=1567 Study eyes
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
Artificial Tears
n=1600 Study eyes
Placebo comparator - one drop two times daily for four weeks
|
|---|---|---|
|
Efficacy Measure 3 - Lashes
Number of upper eyelid lashes touching the cornea at one year
|
0.13 Lashes touching
Standard Deviation 0.57
|
0.16 Lashes touching
Standard Deviation 0.73
|
|
Efficacy Measure 3 - Lashes
Total number of upper eyelid lashes touching the globe or the cornea at one year
|
0.21 Lashes touching
Standard Deviation 0.78
|
0.22 Lashes touching
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: 1 yearMarginal cost per case of postoperative trichiasis avoided (Cost-effectiveness in the use of Fluorometholone 0.1%)
Outcome measures
| Measure |
Fluorometholone
n=1180 Participants
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
Artificial Tears
n=1181 Participants
Placebo comparator - one drop two times daily for four weeks
|
|---|---|---|
|
Efficacy Measure 4 - Health Economic Analysis
|
55556 cost (2026 USD)/(PTT case avoided)
|
0 cost (2026 USD)/(PTT case avoided)
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Numbers analyzed may differ due to different number of patients that completed each follow up visit due to reasons such as death or lost to follow up.
Presence and grade of corneal opacity in study eyes
Outcome measures
| Measure |
Fluorometholone
n=1567 Study eyes
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
Artificial Tears
n=1600 Study eyes
Placebo comparator - one drop two times daily for four weeks
|
|---|---|---|
|
Safety/Adverse Outcomes 1 - Corneal Opacity
No
|
1064 Study eyes
|
1068 Study eyes
|
|
Safety/Adverse Outcomes 1 - Corneal Opacity
Yes
|
503 Study eyes
|
532 Study eyes
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Numbers analyzed may differ due to different number of patients that completed each follow up visit due to reasons such as death or lost to follow up.
Presence of overcorrection in study eyes
Outcome measures
| Measure |
Fluorometholone
n=1567 Study eyes
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
Artificial Tears
n=1600 Study eyes
Placebo comparator - one drop two times daily for four weeks
|
|---|---|---|
|
Safety/Adverse Outcomes 2 - Overcorrection
No
|
1558 Study eyes
|
1587 Study eyes
|
|
Safety/Adverse Outcomes 2 - Overcorrection
Yes
|
9 Study eyes
|
13 Study eyes
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Numbers analyzed may differ due to different number of patients that completed each follow up visit due to reasons such as death or lost to follow up.
Presence of eyelid notching/eyelid contour abnormalities in study eyes
Outcome measures
| Measure |
Fluorometholone
n=1567 Study eyes
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
Artificial Tears
n=1600 Study eyes
Placebo comparator - one drop two times daily for four weeks
|
|---|---|---|
|
Safety/Adverse Outcomes 3 - Eyelid Abnormalities
No
|
1525 Study eyes
|
1542 Study eyes
|
|
Safety/Adverse Outcomes 3 - Eyelid Abnormalities
Yes
|
42 Study eyes
|
58 Study eyes
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Numbers analyzed may differ due to different number of patients that completed each follow up visit due to reasons such as death or lost to follow up.
Presence of lid closure defect in study eyes
Outcome measures
| Measure |
Fluorometholone
n=1567 Study eyes
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
Artificial Tears
n=1600 Study eyes
Placebo comparator - one drop two times daily for four weeks
|
|---|---|---|
|
Safety/Adverse Outcome 4 - Lid Closure Defect
No
|
1567 Study eyes
|
1598 Study eyes
|
|
Safety/Adverse Outcome 4 - Lid Closure Defect
Yes
|
0 Study eyes
|
2 Study eyes
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Numbers analyzed may differ due to different number of patients that completed each follow up visit due to reasons such as death or lost to follow up.
Presence of granuloma in study eyes at 1 year
Outcome measures
| Measure |
Fluorometholone
n=1567 Study eyes
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
Artificial Tears
n=1600 Study eyes
Placebo comparator - one drop two times daily for four weeks
|
|---|---|---|
|
Safety/Adverse Outcomes 5 - Granuloma
No
|
1564 Study eyes
|
1595 Study eyes
|
|
Safety/Adverse Outcomes 5 - Granuloma
Yes
|
3 Study eyes
|
5 Study eyes
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Numbers analyzed may differ due to different number of patients that completed each follow up visit due to reasons such as death or lost to follow up.
Pain scale score ranges from 5 (least pain) to 20 (most pain)
Outcome measures
| Measure |
Fluorometholone
n=1567 Study eye
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
Artificial Tears
n=1600 Study eye
Placebo comparator - one drop two times daily for four weeks
|
|---|---|---|
|
Safety/Adverse Outcomes 6 - Pain Level
|
5.32 Point
Standard Deviation 1.4
|
5.35 Point
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Numbers analyzed may differ due to different number of patients that completed each follow up visit due to reasons such as death or lost to follow up.
Intraocular pressure (IOP) elevation ≥ 10 mmHg from baseline in study eyes at week 4
Outcome measures
| Measure |
Fluorometholone
n=1189 Participants
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
Artificial Tears
n=1195 Participants
Placebo comparator - one drop two times daily for four weeks
|
|---|---|---|
|
Safety/Adverse Outcomes 7 - IOP in mmHg
No
|
1577 Study eyes
|
1612 Study eyes
|
|
Safety/Adverse Outcomes 7 - IOP in mmHg
Yes
|
7 Study eyes
|
5 Study eyes
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Numbers analyzed may differ due to different number of patients that completed each follow up visit due to reasons such as death or lost to follow up.
Occurrence of cataract surgery in study eyes
Outcome measures
| Measure |
Fluorometholone
n=1593 Study eyes
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
Artificial Tears
n=1625 Study eyes
Placebo comparator - one drop two times daily for four weeks
|
|---|---|---|
|
Safety/Adverse Outcomes 8 - Cataract Surgery
No
|
1590 Study eyes
|
1618 Study eyes
|
|
Safety/Adverse Outcomes 8 - Cataract Surgery
Yes
|
3 Study eyes
|
7 Study eyes
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Consider fellow eye that doesn't have previous upper lid eyelid surgery for TT and diagnosis of upper eyelid TT at baseline, and fellow eye that cannot determine the TT status based on week 4, month 6 and month 12 visit are excluded.
Cumulative incidence of TT in the fellow eye by one year
Outcome measures
| Measure |
Fluorometholone
n=550 Fellow eye
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
Artificial Tears
n=513 Fellow eye
Placebo comparator - one drop two times daily for four weeks
|
|---|---|---|
|
Safety/Adverse Outcomes 9 - TT in Non-study Eye
Number of Fellow Eye without TT
|
431 Fellow eye
|
406 Fellow eye
|
|
Safety/Adverse Outcomes 9 - TT in Non-study Eye
Number of Fellow Eye with TT
|
119 Fellow eye
|
107 Fellow eye
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Numbers analyzed may differ due to different number of patients that completed each follow up visit due to reasons such as death or lost to follow up.
Adverse events attributed to study treatment by one year
Outcome measures
| Measure |
Fluorometholone
n=1204 Participants
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
Artificial Tears
n=1206 Participants
Placebo comparator - one drop two times daily for four weeks
|
|---|---|---|
|
Safety/Adverse Outcomes 10 - Adverse Events
No
|
1197 Participants
|
1195 Participants
|
|
Safety/Adverse Outcomes 10 - Adverse Events
Yes, not serious
|
4 Participants
|
9 Participants
|
|
Safety/Adverse Outcomes 10 - Adverse Events
No surgery due to withdrawal after randomization
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Numbers analyzed may differ due to different number of patients that completed each follow up visit due to reasons such as death or lost to follow up.
Patient satisfaction level in regards to the trichiasis surgery outcome measured on a likert scale for satisfaction (from very dissatisfied to very satisfied)
Outcome measures
| Measure |
Fluorometholone
n=1567 Study eyes
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
Artificial Tears
n=1600 Study eyes
Placebo comparator - one drop two times daily for four weeks
|
|---|---|---|
|
Patient-reported Outcomes 1 - Patient Satisfaction
Very dissatisfied
|
0 Study eyes
|
1 Study eyes
|
|
Patient-reported Outcomes 1 - Patient Satisfaction
Very satisfied
|
1468 Study eyes
|
1461 Study eyes
|
|
Patient-reported Outcomes 1 - Patient Satisfaction
Satisfied
|
93 Study eyes
|
128 Study eyes
|
|
Patient-reported Outcomes 1 - Patient Satisfaction
Neither satisfied nor dissatisfied
|
4 Study eyes
|
5 Study eyes
|
|
Patient-reported Outcomes 1 - Patient Satisfaction
Dissatisfied
|
2 Study eyes
|
5 Study eyes
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Numbers analyzed may differ due to different number of patients that completed each follow up visit due to reasons such as death or lost to follow up.
Patient satisfaction level in regards to the cosmetic outcome of the trichiasis surgery measured on a likert scale for satisfaction (from very dissatisfied to very satisfied)
Outcome measures
| Measure |
Fluorometholone
n=1567 Study eyes
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
Artificial Tears
n=1600 Study eyes
Placebo comparator - one drop two times daily for four weeks
|
|---|---|---|
|
Patient-reported Outcomes 2 - Cosmetic Outcome
Very satisfied
|
1457 Study eyes
|
1458 Study eyes
|
|
Patient-reported Outcomes 2 - Cosmetic Outcome
Satisfied
|
105 Study eyes
|
136 Study eyes
|
|
Patient-reported Outcomes 2 - Cosmetic Outcome
Very dissatisfied
|
0 Study eyes
|
1 Study eyes
|
|
Patient-reported Outcomes 2 - Cosmetic Outcome
Neither satisfied nor dissatisfied
|
4 Study eyes
|
3 Study eyes
|
|
Patient-reported Outcomes 2 - Cosmetic Outcome
Dissatisfied
|
1 Study eyes
|
2 Study eyes
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Numbers analyzed may differ due to different number of patients that completed each follow up visit due to reasons such as death or lost to follow up.
Quality of life assessed using the tool EuroQol 5 Dimensions (EQ-5D) comprising mobility, self-care, usual activities, pain/discomfort and anxiety/depression dimensions and assessed on five levels from no problems to extreme problems
Outcome measures
| Measure |
Fluorometholone
n=1180 Participants
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
Artificial Tears
n=1181 Participants
Placebo comparator - one drop two times daily for four weeks
|
|---|---|---|
|
Patient-reported Outcomes 3 - Health Utility
Severity index (0-25, higher is worse)
|
6.3 Point
Standard Deviation 2.69
|
6.3 Point
Standard Deviation 2.61
|
|
Patient-reported Outcomes 3 - Health Utility
Health state score (0-100, higher is better)
|
79.6 Point
Standard Deviation 15.66
|
80.2 Point
Standard Deviation 15.51
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Numbers analyzed may differ due to different number of patients that completed each follow up visit due to reasons such as death or lost to follow up.
Visual acuity with presenting correction in study eyes
Outcome measures
| Measure |
Fluorometholone
n=1567 Study eyes
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
Artificial Tears
n=1600 Study eyes
Placebo comparator - one drop two times daily for four weeks
|
|---|---|---|
|
Additional Variables 1 - Visual Acuity
Visual acuity at 1 year
|
0.48 logMAR
Standard Deviation 0.48
|
0.48 logMAR
Standard Deviation 0.48
|
|
Additional Variables 1 - Visual Acuity
Change from baseline at 1 year
|
-0.03 logMAR
Standard Deviation 0.33
|
-0.02 logMAR
Standard Deviation 0.36
|
Adverse Events
Artificial Tears
Serious events: 83 serious events
Other events: 382 other events
Deaths: 6 deaths
Fluorometholone
Serious events: 88 serious events
Other events: 287 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Artificial Tears
n=1206 participants at risk
Placebo comparator - one drop two times daily for four weeks
|
Fluorometholone
n=1204 participants at risk
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
|---|---|---|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/1206 • From enrollment until end of follow-up, up to 1 year
|
0.08%
1/1204 • Number of events 1 • From enrollment until end of follow-up, up to 1 year
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/1206 • From enrollment until end of follow-up, up to 1 year
|
0.08%
1/1204 • Number of events 1 • From enrollment until end of follow-up, up to 1 year
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/1206 • From enrollment until end of follow-up, up to 1 year
|
0.08%
1/1204 • Number of events 1 • From enrollment until end of follow-up, up to 1 year
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.08%
1/1206 • Number of events 1 • From enrollment until end of follow-up, up to 1 year
|
0.00%
0/1204 • From enrollment until end of follow-up, up to 1 year
|
|
Investigations
SURGERY
|
0.00%
0/1206 • From enrollment until end of follow-up, up to 1 year
|
0.17%
2/1204 • Number of events 2 • From enrollment until end of follow-up, up to 1 year
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.08%
1/1206 • Number of events 1 • From enrollment until end of follow-up, up to 1 year
|
0.00%
0/1204 • From enrollment until end of follow-up, up to 1 year
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
0.08%
1/1206 • Number of events 1 • From enrollment until end of follow-up, up to 1 year
|
0.00%
0/1204 • From enrollment until end of follow-up, up to 1 year
|
|
Endocrine disorders
GOITRE
|
0.00%
0/1206 • From enrollment until end of follow-up, up to 1 year
|
0.08%
1/1204 • Number of events 1 • From enrollment until end of follow-up, up to 1 year
|
|
Eye disorders
BLINDNESS
|
0.08%
1/1206 • Number of events 1 • From enrollment until end of follow-up, up to 1 year
|
0.00%
0/1204 • From enrollment until end of follow-up, up to 1 year
|
|
Eye disorders
ECTROPION
|
0.08%
1/1206 • Number of events 1 • From enrollment until end of follow-up, up to 1 year
|
0.00%
0/1204 • From enrollment until end of follow-up, up to 1 year
|
|
Eye disorders
EYE PAIN
|
0.08%
1/1206 • Number of events 1 • From enrollment until end of follow-up, up to 1 year
|
0.00%
0/1204 • From enrollment until end of follow-up, up to 1 year
|
|
Eye disorders
GLAUCOMA
|
0.17%
2/1206 • Number of events 2 • From enrollment until end of follow-up, up to 1 year
|
0.00%
0/1204 • From enrollment until end of follow-up, up to 1 year
|
|
Eye disorders
INTRAOCULAR PRESSURE INCREASED
|
0.08%
1/1206 • Number of events 1 • From enrollment until end of follow-up, up to 1 year
|
0.08%
1/1204 • Number of events 1 • From enrollment until end of follow-up, up to 1 year
|
|
Eye disorders
TRICHIASIS
|
5.6%
67/1206 • Number of events 67 • From enrollment until end of follow-up, up to 1 year
|
5.8%
70/1204 • Number of events 70 • From enrollment until end of follow-up, up to 1 year
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/1206 • From enrollment until end of follow-up, up to 1 year
|
0.08%
1/1204 • Number of events 1 • From enrollment until end of follow-up, up to 1 year
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/1206 • From enrollment until end of follow-up, up to 1 year
|
0.08%
1/1204 • Number of events 1 • From enrollment until end of follow-up, up to 1 year
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/1206 • From enrollment until end of follow-up, up to 1 year
|
0.08%
1/1204 • Number of events 1 • From enrollment until end of follow-up, up to 1 year
|
|
General disorders
HERNIA
|
0.08%
1/1206 • Number of events 1 • From enrollment until end of follow-up, up to 1 year
|
0.00%
0/1204 • From enrollment until end of follow-up, up to 1 year
|
|
General disorders
DEATH
|
0.50%
6/1206 • Number of events 6 • From enrollment until end of follow-up, up to 1 year
|
0.66%
8/1204 • Number of events 8 • From enrollment until end of follow-up, up to 1 year
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.08%
1/1206 • Number of events 1 • From enrollment until end of follow-up, up to 1 year
|
0.08%
1/1204 • Number of events 1 • From enrollment until end of follow-up, up to 1 year
|
Other adverse events
| Measure |
Artificial Tears
n=1206 participants at risk
Placebo comparator - one drop two times daily for four weeks
|
Fluorometholone
n=1204 participants at risk
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
|
|---|---|---|
|
Eye disorders
ECTROPION
|
13.5%
163/1206 • Number of events 172 • From enrollment until end of follow-up, up to 1 year
|
9.9%
119/1204 • Number of events 122 • From enrollment until end of follow-up, up to 1 year
|
|
Eye disorders
EYELID DISORDER
|
17.2%
207/1206 • Number of events 220 • From enrollment until end of follow-up, up to 1 year
|
14.0%
168/1204 • Number of events 178 • From enrollment until end of follow-up, up to 1 year
|
|
Eye disorders
EYELID VASCULAR DISORDER
|
8.7%
105/1206 • Number of events 111 • From enrollment until end of follow-up, up to 1 year
|
3.1%
37/1204 • Number of events 37 • From enrollment until end of follow-up, up to 1 year
|
Additional Information
John Kempen, MD, MPH, PhD, MHS
Massachusetts Eye and Ear
Phone: +1-617-573-4494
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place