Malini, D (2022) Comparison of the Efficacy and Safety of Preservative Free Travoprost 0.004% with Travoprost 0.004% with Polyqaternium-1 as Preservative in Patients with Primary Open Angle Glaucoma and Ocular Hypertension: A Randomized Controlled Trial. Masters thesis, Christian Medical College, Vellore.
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Abstract
AIM OF THE STUDY: To compare the efficacy and safety of preservative free Travoprost 0.004% (AWARENE PF®) with polyquarternium-1 preserved Travoprost 0.004% (TRAVATAN*) in patients with primary open angle glaucoma (POAG) and ocular hypertension (OHT). DESIGN: A prospective, randomised controlled Phase 3 clinical trial. SETTING: Department of Ophthalmology, Christian Medical College, Vellore SAMPLE SIZE CALCULATION: The sample size was calculated based on the primary outcome measure i.e., the difference in the mean IOP at 6 weeks by treatment groups. Allowing for an estimated dropout rate of 10%, a mean difference of 3 mm Hg between the groups, a power of 80%, the sample size was planned to include a total of 62 patients in the study with 31 in each arm. PARTICIPANTS: Given the Covid 19 pandemic, its restrictions and the stringent inclusion, exclusion and follow up criteria, we were able to recruit only 15 patients with newly diagnosed POAG and OHT in the study after an informed consent. Participants included in the study were randomly allocated in a 1:1 ratio to one of the two treatment groups using a computer-generated block randomization with block size 2, 4 and 6. METHODOLOGY: All patients underwent ocular surface examination including TBUT, Schirmer 1A, SPK grading and conjunctival staining with Lissamine Green and slitlamp photograph for conjunctival hyperemia. Intraocular pressure measurement using Goldmann applanation tonometer at 9:00am, 1:00pm and 5:00pm, gonioscopy and slit lamp biomicroscopic examination of the optic nerve head using a 78 diopters condensing lens were performed. Central corneal thickness measurement was done using TOMEY BIO & PACHY METER AL-4000, automated perimetry using Humphrey field analyzer ZIESS 750I, and OCT scans for retinal nerve fiber layer thickness and macular thickness using SWEPT SOURCE OCT DRI TRITON (plus) TOPCON as per standard protocol were performed on all patients at baseline. Those in ARM A, were dispensed Awarene® PF eye drops and those in ARM B, were started on Travatan* eye drops. Patients were advised to keep the allotted medication in the refrigerator to ensure that the temperature is below 300C and instill the drops at the same time everyday (9:00 pm +/- 30 minutes) for 6 weeks. Patients were followed up at 2 weeks for IOP measurement. Those patients with inadequate reduction in IOP and major adverse events were taken out of the study. At the 6 week follow up, a slit lamp photograph of conjunctiva, IOP measurement at 09:00 am, 1:00 pm, and 5:00pm and ocular surface evaluation including TBUT, Schirmer 1A, SPK grading and conjunctival staining with Lissamine Green were performed. MAIN OUTCOME MEASURES: The primary outcome was to assess and compare IOP reduction at 6 weeks in both arms. Secondary outcome was to assess and compare the ocular side effects and surface changes. RESULTS: 15 patients with POAG and OHT were randomized to receive either preservative free Travoprost 0.004% (Awarene® PF; Arm A) or polyquarternium-1 preserved Travoprost 0.004% (TRAVATAN*; Arm B). 8 patients were treated with Awarene® PF and 7 patients received TRAVATAN*. All patients were followed up at two and six weeks. Fischer exact test done for comparing categorical variables since more than 20% of the cells had expected count less than 5 and t test was used to compare the means of two arms. There was a significant reduction of IOP at 2 weeks with both AWARENE® PF (32%) and with TRAVATAN*(28%). This reduction persisted at 6 weeks with 36% reduction in Arm A and 27% reduction in Arm B. There was no statistically significant difference in mean IOP between the two arms at 2 weeks (p=0.961) and 6 weeks (p=0.156). . There was no major ocular surface complication in either Arm at 6 weeks when compared to baseline. CONCLUSIONS: Travoprost 0.004% preserved with polyquarternium-1 (TRAVATAN*) and preservative free Travoprost 0.004% (Awarene PF®) produced adequate IOP reduction in patients with POAG and OHT from 2 weeks to 6 weeks follow up. There was no statistically significant difference in IOP reduction at 2-6 weeks follow up between both medications. There were no significant ocular side effects and surface changes in eyes with TRAVATAN* and Awarene PF® PF up to 6 weeks.
| Item Type: | Thesis (Masters) |
|---|---|
| Additional Information: | 221913305 |
| Uncontrolled Keywords: | Glaucoma, intraocular pressure, ocular surface changes, prostaglandin analogue. preservatives. |
| Subjects: | MEDICAL > Ophthalmology > MEDICAL > Ophthalmology |
| Depositing User: | Subramani R |
| Date Deposited: | 11 Apr 2021 09:38 |
| Last Modified: | 08 Jan 2024 03:27 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/14599 |
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