Trial Outcomes & Findings for Performance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms. (NCT NCT05931861)
NCT ID: NCT05931861
Last Updated: 2025-01-31
Results Overview
The primary endpoint is the change from baseline (Day 1) to Day 36 in the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score. CLDEQ-8 consists of 8 questions designed to measure dry eye symptoms specifically related to the use of contact lenses. The total score is obtained by adding the scores obtained for each answer. The final score is ranging from 1 to 37. 37 is the worst score.
COMPLETED
NA
34 participants
CLDEQ- score is assessed at Day 1 and Day 36
2025-01-31
Participant Flow
Participant milestones
| Measure |
T2769
One drop in each eye, from 3 to 6 times daily, at any time but only when patients are wearing their contact lenses.
T2769: T2769: sodium hyaluronate 0.15%, Trehalose 3%, Naaga 2.45% in a 12.5 mL ABAK® multi-dose bottle.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
T2769
n=34 Participants
One drop in each eye, from 3 to 6 times daily, at any time but only when patients are wearing their contact lenses.
T2769: T2769: sodium hyaluronate 0.15%, Trehalose 3%, Naaga 2.45% in a 12.5 mL ABAK® multi-dose bottle.
|
|---|---|
|
Age, Continuous
|
39.7 years
STANDARD_DEVIATION 14 • n=34 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=34 Participants
|
PRIMARY outcome
Timeframe: CLDEQ- score is assessed at Day 1 and Day 36The primary endpoint is the change from baseline (Day 1) to Day 36 in the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score. CLDEQ-8 consists of 8 questions designed to measure dry eye symptoms specifically related to the use of contact lenses. The total score is obtained by adding the scores obtained for each answer. The final score is ranging from 1 to 37. 37 is the worst score.
Outcome measures
| Measure |
T2769
n=34 Participants
One drop in each eye, from 3 to 6 times daily, at any time but only when patients are wearing their contact lenses.
T2769: T2769: sodium hyaluronate 0.15%, Trehalose 3%, Naaga 2.45% in a 12.5 mL ABAK® multi-dose bottle.
|
|---|---|
|
Change From Baseline in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Total Score.
|
-12.6 score on a scale
Standard Deviation 5.0
|
Adverse Events
T2769
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The data resulting from this clinical investigation will be the proprietary information of Sponsor. An investigator shall not publish any data (poster, abstract, paper, etc.) without having consulted with Laboratoires THÉA in advance.
- Publication restrictions are in place
Restriction type: OTHER