Trial Outcomes & Findings for Study to Compare the Efficacy of the Ophthalmic Solution Humylub Ofteno® PF With Hyabak® and Lagricel Ofteno® PF as Treatment for Dry Eye. (NCT NCT04702776)
NCT ID: NCT04702776
Last Updated: 2026-01-13
Results Overview
OSDI is a 12-item questionnaire used to evaluate symptoms associated with dry eye disease, as well as classify their severity. According the obtained score, categories are as follows: normal (0-12 points), mild (13-22 points), moderate (23-32 points), or severe (33-100 points). A higher score is a worse outcome. • This outcome measure considered the Per Protocol (PP) population.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
182 participants
Primary outcome timeframe
Days: 0 (± 2) (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
Results posted on
2026-01-13
Participant Flow
The minimun sample size was not reached secondary to follow up loss and protocol deviations. Therefore, the efficacy analysis was performed in an exploratory manner and it was not possible to contrast the hypoteses.
Participant milestones
| Measure |
Arm 1; Humylub Ofteno® PF
Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%: Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.
|
Arm 2; Hyabak®
Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.15%: Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.
|
Arm 3; Lagricel Ofteno® PF
Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.4%: Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
61
|
61
|
60
|
|
Overall Study
COMPLETED
|
56
|
56
|
52
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
8
|
Reasons for withdrawal
| Measure |
Arm 1; Humylub Ofteno® PF
Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%: Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.
|
Arm 2; Hyabak®
Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.15%: Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.
|
Arm 3; Lagricel Ofteno® PF
Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.4%: Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
4
|
|
Overall Study
Protocol Violation
|
2
|
2
|
3
|
Baseline Characteristics
Study to Compare the Efficacy of the Ophthalmic Solution Humylub Ofteno® PF With Hyabak® and Lagricel Ofteno® PF as Treatment for Dry Eye.
Baseline characteristics by cohort
| Measure |
Arm 1; Humylub Ofteno® PF
n=61 Participants
Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%: Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.
|
Arm 2; Hyabak®
n=61 Participants
Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.15%: Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.
|
Arm 3; Lagricel Ofteno® PF
n=60 Participants
Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.4%: Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=210 Participants
|
61 Participants
n=19 Participants
|
60 Participants
n=123 Participants
|
182 Participants
n=123 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
|
Age, Continuous
|
29.5 years
STANDARD_DEVIATION 11 • n=210 Participants
|
31.7 years
STANDARD_DEVIATION 11.7 • n=19 Participants
|
31.4 years
STANDARD_DEVIATION 10.2 • n=123 Participants
|
30.9 years
STANDARD_DEVIATION 11 • n=123 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=210 Participants
|
33 Participants
n=19 Participants
|
36 Participants
n=123 Participants
|
102 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=210 Participants
|
28 Participants
n=19 Participants
|
24 Participants
n=123 Participants
|
80 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
61 Participants
n=210 Participants
|
61 Participants
n=19 Participants
|
60 Participants
n=123 Participants
|
182 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
|
Region of Enrollment
Mexico
|
61 participants
n=210 Participants
|
61 participants
n=19 Participants
|
60 participants
n=123 Participants
|
182 participants
n=123 Participants
|
|
Conjunctival hyperemia
|
24 Participants
n=210 Participants
|
19 Participants
n=19 Participants
|
16 Participants
n=123 Participants
|
59 Participants
n=123 Participants
|
PRIMARY outcome
Timeframe: Days: 0 (± 2) (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).Population: In total, 18 participants were discontinued from the study.
OSDI is a 12-item questionnaire used to evaluate symptoms associated with dry eye disease, as well as classify their severity. According the obtained score, categories are as follows: normal (0-12 points), mild (13-22 points), moderate (23-32 points), or severe (33-100 points). A higher score is a worse outcome. • This outcome measure considered the Per Protocol (PP) population.
Outcome measures
| Measure |
Arm 1; Humylub Ofteno® PF
n=46 Participants
Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%: Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.
|
Arm 2; Hyabak®
n=49 Participants
Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.15%: Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.
|
Arm 3; Lagricel Ofteno® PF
n=40 Participants
Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.4%: Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
|
|---|---|---|---|
|
Change in Ocular Surface Disease Index (OSDI)
Elegibility visit
|
26.4 score on a scale
Standard Deviation 5.1
|
26.3 score on a scale
Standard Deviation 5.8
|
26.6 score on a scale
Standard Deviation 4.9
|
|
Change in Ocular Surface Disease Index (OSDI)
First follow-up visit
|
16.4 score on a scale
Standard Deviation 8.3
|
14.0 score on a scale
Standard Deviation 10.4
|
15.2 score on a scale
Standard Deviation 8.3
|
|
Change in Ocular Surface Disease Index (OSDI)
Final visit
|
11.2 score on a scale
Standard Deviation 9.4
|
8.8 score on a scale
Standard Deviation 7.5
|
10.7 score on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Days: 0 - 2 (baseline visit),17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).Population: In total, 18 participants were discontinued from the study.
This evaluation will be performed through an Oculus Keratograph 5M, and the parameter "first break-up time" will be recorded as NIKBUT. A lower value is a worse outcome. This outcome measure considered the Per Protocol (PP) population.
Outcome measures
| Measure |
Arm 1; Humylub Ofteno® PF
n=46 Participants
Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%: Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.
|
Arm 2; Hyabak®
n=49 Participants
Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.15%: Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.
|
Arm 3; Lagricel Ofteno® PF
n=40 Participants
Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.4%: Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
|
|---|---|---|---|
|
Noninvasive Keratograph Break-up Time (NIKBUT)
Baseline visit
|
6.8 seconds
Standard Deviation 3.9
|
5.2 seconds
Standard Deviation 3.0
|
7.1 seconds
Standard Deviation 4.3
|
|
Noninvasive Keratograph Break-up Time (NIKBUT)
First follow-up visit
|
7.3 seconds
Standard Deviation 4.8
|
6.9 seconds
Standard Deviation 4.8
|
7.7 seconds
Standard Deviation 4.9
|
|
Noninvasive Keratograph Break-up Time (NIKBUT)
Final visit
|
8.7 seconds
Standard Deviation 5.3
|
7.8 seconds
Standard Deviation 4.9
|
7.1 seconds
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).Population: In total, 18 participants were discontinued from the study.
The change in proportion of participant's abscence of conjunctival and corneal staining with lissamine green will be analyzed. The evaluation will take place after applying the lissamine green stain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V). This outcome measure considered the Per Protocol (PP) population.
Outcome measures
| Measure |
Arm 1; Humylub Ofteno® PF
n=46 Participants
Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%: Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.
|
Arm 2; Hyabak®
n=49 Participants
Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.15%: Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.
|
Arm 3; Lagricel Ofteno® PF
n=40 Participants
Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.4%: Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
|
|---|---|---|---|
|
Change of Conjunctival and Corneal Staining With Lissamine Green
Eligibility visit · 0
|
20 Participants
|
23 Participants
|
16 Participants
|
|
Change of Conjunctival and Corneal Staining With Lissamine Green
Eligibility visit · I
|
21 Participants
|
22 Participants
|
24 Participants
|
|
Change of Conjunctival and Corneal Staining With Lissamine Green
Eligibility visit · II
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Change of Conjunctival and Corneal Staining With Lissamine Green
Eligibility visit · III
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Change of Conjunctival and Corneal Staining With Lissamine Green
Eligibility visit · IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change of Conjunctival and Corneal Staining With Lissamine Green
First follow-up visit · 0
|
25 Participants
|
28 Participants
|
25 Participants
|
|
Change of Conjunctival and Corneal Staining With Lissamine Green
First follow-up visit · I
|
16 Participants
|
19 Participants
|
12 Participants
|
|
Change of Conjunctival and Corneal Staining With Lissamine Green
First follow-up visit · II
|
4 Participants
|
1 Participants
|
3 Participants
|
|
Change of Conjunctival and Corneal Staining With Lissamine Green
First follow-up visit · III
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change of Conjunctival and Corneal Staining With Lissamine Green
First follow-up visit · IV
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Change of Conjunctival and Corneal Staining With Lissamine Green
Final visit · 0
|
33 Participants
|
32 Participants
|
23 Participants
|
|
Change of Conjunctival and Corneal Staining With Lissamine Green
Final visit · I
|
12 Participants
|
15 Participants
|
17 Participants
|
|
Change of Conjunctival and Corneal Staining With Lissamine Green
Final visit · II
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Change of Conjunctival and Corneal Staining With Lissamine Green
Final visit · III
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change of Conjunctival and Corneal Staining With Lissamine Green
Final visit · IV
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).Population: In total, 18 participants were discontinued from the study.
The change in proportion of participant's abscence of conjunctival and corneal staining with fluorescein will be analyzed. The evaluation will take place after applying the fluorescein stain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V). This outcome measure considered the Per Protocol (PP) population.
Outcome measures
| Measure |
Arm 1; Humylub Ofteno® PF
n=46 Participants
Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%: Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.
|
Arm 2; Hyabak®
n=49 Participants
Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.15%: Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.
|
Arm 3; Lagricel Ofteno® PF
n=40 Participants
Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.4%: Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
|
|---|---|---|---|
|
Change of Conjunctival and Corneal Staining With Fluorescein
Elegibility visit · 0
|
19 Participants
|
20 Participants
|
16 Participants
|
|
Change of Conjunctival and Corneal Staining With Fluorescein
Elegibility visit · I
|
19 Participants
|
27 Participants
|
20 Participants
|
|
Change of Conjunctival and Corneal Staining With Fluorescein
Elegibility visit · II
|
7 Participants
|
2 Participants
|
4 Participants
|
|
Change of Conjunctival and Corneal Staining With Fluorescein
Elegibility visit · III
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Change of Conjunctival and Corneal Staining With Fluorescein
First follow-up visit · 0
|
31 Participants
|
23 Participants
|
25 Participants
|
|
Change of Conjunctival and Corneal Staining With Fluorescein
First follow-up visit · I
|
12 Participants
|
22 Participants
|
14 Participants
|
|
Change of Conjunctival and Corneal Staining With Fluorescein
First follow-up visit · II
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Change of Conjunctival and Corneal Staining With Fluorescein
First follow-up visit · III
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change of Conjunctival and Corneal Staining With Fluorescein
Final visit · 0
|
36 Participants
|
34 Participants
|
24 Participants
|
|
Change of Conjunctival and Corneal Staining With Fluorescein
Final visit · I
|
10 Participants
|
15 Participants
|
14 Participants
|
|
Change of Conjunctival and Corneal Staining With Fluorescein
Final visit · II
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Change of Conjunctival and Corneal Staining With Fluorescein
Final visit · III
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).Population: In total, 18 participants were discontinued from the study.
The change in proportion of participant's score will be analyzed. Rate of conjunctival hyperemia will be evaluated through the Efron scale which includes 5 grades: Normal (0), Very Mild (I), Mild (II), Moderate (3), and Severe (4). This outcome measure considered the Per Protocol (PP) population.
Outcome measures
| Measure |
Arm 1; Humylub Ofteno® PF
n=46 Participants
Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%: Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.
|
Arm 2; Hyabak®
n=49 Participants
Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.15%: Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.
|
Arm 3; Lagricel Ofteno® PF
n=40 Participants
Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.4%: Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
|
|---|---|---|---|
|
Change in Conjunctival Hyperemia
Final visit · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Conjunctival Hyperemia
Elegibility visit · Very Mild
|
14 Participants
|
17 Participants
|
12 Participants
|
|
Change in Conjunctival Hyperemia
Elegibility visit · Mild
|
9 Participants
|
15 Participants
|
11 Participants
|
|
Change in Conjunctival Hyperemia
Elegibility visit · Normal
|
21 Participants
|
15 Participants
|
14 Participants
|
|
Change in Conjunctival Hyperemia
Elegibility visit · Moderate
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Change in Conjunctival Hyperemia
Elegibility visit · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Conjunctival Hyperemia
First follow-up visit · Normal
|
23 Participants
|
22 Participants
|
22 Participants
|
|
Change in Conjunctival Hyperemia
First follow-up visit · Very Mild
|
17 Participants
|
22 Participants
|
14 Participants
|
|
Change in Conjunctival Hyperemia
First follow-up visit · Mild
|
6 Participants
|
5 Participants
|
4 Participants
|
|
Change in Conjunctival Hyperemia
First follow-up visit · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Conjunctival Hyperemia
First follow-up visit · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Conjunctival Hyperemia
Final visit · Normal
|
32 Participants
|
33 Participants
|
27 Participants
|
|
Change in Conjunctival Hyperemia
Final visit · Very Mild
|
11 Participants
|
14 Participants
|
13 Participants
|
|
Change in Conjunctival Hyperemia
Final visit · Mild
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Change in Conjunctival Hyperemia
Final visit · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days: 0 (eligibility visit), 0 - 2 (baseline visit),17 - 19 (± 1) (first follow-up visit), 31 - 33 (± 1) (final visit), and 38 - 40 (± 1) (safety call).Number of related non expected adverse events observed per group. This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.
Outcome measures
| Measure |
Arm 1; Humylub Ofteno® PF
n=61 Participants
Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%: Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.
|
Arm 2; Hyabak®
n=61 Participants
Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.15%: Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.
|
Arm 3; Lagricel Ofteno® PF
n=60 Participants
Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.4%: Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
|
|---|---|---|---|
|
Incidence of Related Non Expected Adverse Events
|
5 adverse events
|
5 adverse events
|
10 adverse events
|
SECONDARY outcome
Timeframe: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).Population: This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.
With the patient's best possible refractive correction, visual acuity will be evaluated through the Snellen chart. Its notation (decimal) is described as the distance from the chart at which the test is performed, divided by the distance at which a letter equals vertically 5 minutes of arc. Visual acuity (VA) is a test of visual function. It will be evaluated with the Snellen chart. The Snellen chart is the standard tool used to evaluate visual acuity. It was located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20
Outcome measures
| Measure |
Arm 1; Humylub Ofteno® PF
n=61 Participants
Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%: Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.
|
Arm 2; Hyabak®
n=61 Participants
Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.15%: Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.
|
Arm 3; Lagricel Ofteno® PF
n=60 Participants
Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.4%: Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
|
|---|---|---|---|
|
Change in Best Corrected Visual Acuity (BCVA)
Elegibility visit
|
0.97 decimal
Standard Deviation 0.18
|
0.95 decimal
Standard Deviation 0.21
|
0.94 decimal
Standard Deviation 0.20
|
|
Change in Best Corrected Visual Acuity (BCVA)
First follow-up visit
|
0.99 decimal
Standard Deviation 0.17
|
0.98 decimal
Standard Deviation 0.26
|
0.96 decimal
Standard Deviation 0.22
|
|
Change in Best Corrected Visual Acuity (BCVA)
Final visit
|
0.99 decimal
Standard Deviation 0.2
|
0.96 decimal
Standard Deviation 0.18
|
0.96 decimal
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).Chemosis will be evaluated as present (if conjunctiva separates from the sclera in ≥ 1/3 of the palpebral opening area or if it exceeds the eyelid's gray line) or absent per subject. This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.
Outcome measures
| Measure |
Arm 1; Humylub Ofteno® PF
n=61 Participants
Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%: Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.
|
Arm 2; Hyabak®
n=61 Participants
Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.15%: Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.
|
Arm 3; Lagricel Ofteno® PF
n=60 Participants
Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.4%: Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
|
|---|---|---|---|
|
Change in Incidence of Chemosis
Elegibility visit
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Incidence of Chemosis
First follow-up visit
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Incidence of Chemosis
Final visit
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Arm 1; Humylub Ofteno® PF
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Arm 2; Hyabak®
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Arm 3; Lagricel Ofteno® PF
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1; Humylub Ofteno® PF
n=61 participants at risk
Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%: Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.
|
Arm 2; Hyabak®
n=61 participants at risk
Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.15%: Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.
|
Arm 3; Lagricel Ofteno® PF
n=60 participants at risk
Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.4%: Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
|
|---|---|---|---|
|
Nervous system disorders
Convulsive Crisis
|
1.6%
1/61 • Number of events 1 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
0.00%
0/61 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
0.00%
0/60 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
Other adverse events
| Measure |
Arm 1; Humylub Ofteno® PF
n=61 participants at risk
Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%: Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.
|
Arm 2; Hyabak®
n=61 participants at risk
Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.15%: Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.
|
Arm 3; Lagricel Ofteno® PF
n=60 participants at risk
Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 30 days.
Sodium hyaluronate 0.4%: Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
|
|---|---|---|---|
|
Eye disorders
Ocular burning
|
44.3%
27/61 • Number of events 27 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
47.5%
29/61 • Number of events 33 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
50.0%
30/60 • Number of events 31 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
|
Eye disorders
Pruritus
|
18.0%
11/61 • Number of events 12 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
8.2%
5/61 • Number of events 5 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
25.0%
15/60 • Number of events 15 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
|
Eye disorders
Ocular hyperemia
|
1.6%
1/61 • Number of events 1 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
3.3%
2/61 • Number of events 2 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
0.00%
0/60 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
|
Nervous system disorders
Headache
|
0.00%
0/61 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
0.00%
0/61 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
5.0%
3/60 • Number of events 3 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
|
Eye disorders
Foreign body sensation in the eye
|
8.2%
5/61 • Number of events 5 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
3.3%
2/61 • Number of events 2 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
15.0%
9/60 • Number of events 9 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
|
Eye disorders
Eyestrain
|
3.3%
2/61 • Number of events 2 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
0.00%
0/61 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
3.3%
2/60 • Number of events 2 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
|
Eye disorders
Tearing
|
3.3%
2/61 • Number of events 3 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
1.6%
1/61 • Number of events 1 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
3.3%
2/60 • Number of events 2 • Adverse event data was recollected starting from the elegibility visit (day 0) until the security call (day 38 - 40) done at the end of the study. In this study, AE were collected during of 1 year, 5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place