Trial Outcomes & Findings for Safety, Efficacy Assessment of Geltim LP® 1 mg/g in Ocular Hypertensive or Glaucomatous Patients. (NCT NCT01155219)
NCT ID: NCT01155219
Last Updated: 2017-04-04
Results Overview
Response defined as a combination of satisfactory or acceptable effect on IOP and a reduction of at least 20% of the total tolerance score in the worse eye.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
150 participants
Primary outcome timeframe
Day 84
Results posted on
2017-04-04
Participant Flow
Participant milestones
| Measure |
Geltim LP®
Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days).
Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days).
|
Xalatan®
Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.
Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days).
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
73
|
|
Overall Study
COMPLETED
|
73
|
70
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Geltim LP®
Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days).
Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days).
|
Xalatan®
Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.
Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days).
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
non-medical reason
|
1
|
2
|
Baseline Characteristics
Safety, Efficacy Assessment of Geltim LP® 1 mg/g in Ocular Hypertensive or Glaucomatous Patients.
Baseline characteristics by cohort
| Measure |
Geltim LP®
n=77 Participants
Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days).
Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days).
|
Xalatan®
n=73 Participants
Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.
Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days).
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.94 years
STANDARD_DEVIATION 11.79 • n=99 Participants
|
64.86 years
STANDARD_DEVIATION 11.62 • n=107 Participants
|
65.41 years
STANDARD_DEVIATION 11.68 • n=206 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Region of Enrollment
France
|
77 participants
n=99 Participants
|
73 participants
n=107 Participants
|
150 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 84Population: Full Analysis Set
Response defined as a combination of satisfactory or acceptable effect on IOP and a reduction of at least 20% of the total tolerance score in the worse eye.
Outcome measures
| Measure |
Geltim LP®
n=71 Participants
Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days).
Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days).
|
Xalatan®
n=70 Participants
Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.
Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days).
|
|---|---|---|
|
Ocular Tolerance
|
65 participants
|
34 participants
|
Adverse Events
Geltim LP®
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Xalatan®
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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 All the results of the Trial are the sole and exclusive property of THEA, and cannot be used in whatever form without prior written agreement of THEA.
- Publication restrictions are in place
Restriction type: OTHER