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Background <p>Once a day ophthalmic solution has a higher patient compliance and reduces the issues of multiple dosing regimen. We compared a gel free reservoir containing timolol maleate for efficacy and safety as monotherapy once-daily administration with timolol maleate eye drops 0.5% twice daily.</p> Methods <p>A 6-week, randomized, open-label, parallel-group, active-controlled, multi-centric study in patients aged ≥ 18 years with primary open-angle glaucoma (POAG) or ocular hypertension (OHT). 100 patients were randomized to either a test timolol maleate ophthalmic solution 0.5% once-daily or a comparator twice daily imolol maleate ophthalmic solution 0.5% (Timoptic<sup>®</sup>). Efficacy end points were assessed at two time points on visits 3, 4 and 5 versus baseline.</p> Results <p>The intraocular pressure (IOP)-lowering efficacy of once-a-day timolol Maleate ophthalmic solution 0.5% was comparable to Timoptic<sup>®</sup> administered twice a day at all time points (mean IOP difference and 95% confidence interval within ± 1.2 mmHg; <i>P</i> = 0.2872 to <i>P</i> = 0.3643). The test and the comparator showed no statistically significant differences between Test and Reference in change from baseline at all time-points during the study (<i>P</i> = 0.2872, <i>P</i> = 0.3144, <i>P</i> = 0.3643 at days 8, 15 and 43 respectively). Measurements of peak effect on IOP over the course of the study showed an average reduction of 7.52 mmHg for Test and 6.73 mmHg for Reference, with both the formulations showing significant IOP reduction as compared to the baseline. Both the treatment groups had favourable overall safety profiles with eye irritation and conjunctival ocular hyperemia as the most frequent adverse event in a small proportion of patients.</p> Conclusion <p>A gel free reservoir once-a-day timolol maleate ophthalmic solution was as effective and well tolerated as Timoptic<sup>®</sup>, twice a day solution for treatment of elevated IOP in patients with open-angle glaucoma or ocular hypertension.</p> <p>The permission to conduct this study was obtained from Directorate General of Health Services, Central Drug Standard Control Organization (new Drug Division) Government of India, letter #10,217/935, 14/08/08.</p>

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Efficacy and Safety of Gel-Free Reservoir Ophthalmic Formulation Containing Timolol Maleate in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension

  • 期刊论文

  • 发表日期：

    2026年3月25日

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  • Purvi Bhagat,
  • Anjali Nicholson,
  • Mustafa A. Parekh,
  • Shefali Parikh,
  • Rajul Parikh,
  • Pooja Bhomaj,
  • Nilesh Parekh,
  • Pradeep Jain,
  • Shravanti Bhowmik,
  • Ajay J Khopade,
  • Arindam Halder,
  • Vivek Patel

摘要

Background

Once a day ophthalmic solution has a higher patient compliance and reduces the issues of multiple dosing regimen. We compared a gel free reservoir containing timolol maleate for efficacy and safety as monotherapy once-daily administration with timolol maleate eye drops 0.5% twice daily.

Methods

A 6-week, randomized, open-label, parallel-group, active-controlled, multi-centric study in patients aged ≥ 18 years with primary open-angle glaucoma (POAG) or ocular hypertension (OHT). 100 patients were randomized to either a test timolol maleate ophthalmic solution 0.5% once-daily or a comparator twice daily imolol maleate ophthalmic solution 0.5% (Timoptic®). Efficacy end points were assessed at two time points on visits 3, 4 and 5 versus baseline.

Results

The intraocular pressure (IOP)-lowering efficacy of once-a-day timolol Maleate ophthalmic solution 0.5% was comparable to Timoptic® administered twice a day at all time points (mean IOP difference and 95% confidence interval within ± 1.2 mmHg; P = 0.2872 to P = 0.3643). The test and the comparator showed no statistically significant differences between Test and Reference in change from baseline at all time-points during the study (P = 0.2872, P = 0.3144, P = 0.3643 at days 8, 15 and 43 respectively). Measurements of peak effect on IOP over the course of the study showed an average reduction of 7.52 mmHg for Test and 6.73 mmHg for Reference, with both the formulations showing significant IOP reduction as compared to the baseline. Both the treatment groups had favourable overall safety profiles with eye irritation and conjunctival ocular hyperemia as the most frequent adverse event in a small proportion of patients.

Conclusion

A gel free reservoir once-a-day timolol maleate ophthalmic solution was as effective and well tolerated as Timoptic®, twice a day solution for treatment of elevated IOP in patients with open-angle glaucoma or ocular hypertension.

The permission to conduct this study was obtained from Directorate General of Health Services, Central Drug Standard Control Organization (new Drug Division) Government of India, letter #10,217/935, 14/08/08.