Glaucoma
Conditions
Keywords
Bilateral Glaucoma, Bilateral ocular hypertension, Bilateral primary open angle glaucoma, Bilateral ocular hypertension already treated and controlled by mono-therapy of Xalatan® (1drop per day), With local intolerance signs in at least one eye
Brief summary
This phase IV study aims to assess the safety and the efficacy in intra ocular pressure of Geltim LP® 1 mg/g (0.1% unpreserved timolol maleate gel) in glaucomatous patients initially treated and stabilised by monotherapy of Xalatan® with ocular objective signs of intolerance to prostaglandin eye drops.
Detailed description
The primary objectives are to compare the safety and the efficacy of Geltim LP® 1mg/g eye drops versus Xalatan® eye drops with respect to: The assessment of the ocular tolerance: * Ocular symptoms * Objective ocular signs. The maintain of the IOP efficient lowering effect. Comparison between the 2 study products of the mean basal IOP after a 12 weeks treatment period (84 days ±7).
Interventions
DRUGGeltim LP 1 mg/g
one drop in the conjunctival sac of each eye in the morning (84 days).
DRUGXalatan
one drop in the conjunctival sac of each eye in the morning (84 days).
Sponsors
Laboratoires Thea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent. * Association of the 4 following criteria: 1. \- Bilateral primary open angle glaucoma or bilateral ocular hypertension already treated and controlled by mono-therapy of Xalatan® (1drop per day), 2. \- With local intolerance signs.
Exclusion criteria
* Presence of severe objective ocular sign. * Any ocular hypertension other than primary ocular hypertension or primary chronic open angle glaucoma (such as congenital, angle closure glaucoma, secondary glaucoma). * Absolute defect in the ten degrees central point of the visual field. * Best far corrected visual acuity ≤ 1/10.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Tolerance | Day 84 | 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 77 |
| 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). | 73 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 |
| Overall Study | non-medical reason | 1 | 2 |
Baseline characteristics
| Characteristic | Geltim LP® | Xalatan® | Total |
|---|---|---|---|
| Age, Continuous | 65.94 years STANDARD_DEVIATION 11.79 | 64.86 years STANDARD_DEVIATION 11.62 | 65.41 years STANDARD_DEVIATION 11.68 |
| Region of Enrollment France | 77 participants | 73 participants | 150 participants |
| Sex: Female, Male Female | 49 Participants | 50 Participants | 99 Participants |
| Sex: Female, Male Male | 28 Participants | 23 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 77 | 0 / 73 |
| serious Total, serious adverse events | 0 / 77 | 0 / 73 |
Outcome results
Primary
Ocular Tolerance
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.
Time frame: Day 84
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Geltim LP® | Ocular Tolerance | 65 participants |
| Xalatan® | Ocular Tolerance | 34 participants |
p-value: <0.001Fisher Exact