Avunduk 2005.
| Methods | Parallel‐group RCT | |
| Participants | 49 participants recruited with seasonal allergic conjunctivitis | |
| Interventions | Three treatment arms: ketotifen 0.025% ophthalmic solution; olopatadine hydrochloride 0.1% ophthalmic solution; artificial tear substitute (preservative free). Duration of treatment 30 days, follow‐up 30 days (2‐month study) | |
| Outcomes | Participant evaluation of ocular symptoms (itching, tearing) Investigator assessment of ocular signs (redness, eyelid swelling, chemosis) Mean scores (using a scale range 0‐3; 0 = none, 3 = severe) Time points: at day 0, 15, and 30 of treatment |
|
| Country | Turkey | |
| Number randomised, gender (male:female) | 39 participants randomised. M:F 20:19 | |
| Age mean (SD), median, range | Overall range 18‐61 years | |
| Notes | Study conducted from April to May 2004. Source of funding not stated. Declaration of interest by the authors was not stated | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated list (p.1394 ‐ study medications): "Eligible patients were randomly assigned, in a 1:1 ratio using a computer‐generated list of random numbers..." |
| Allocation concealment (selection bias) | Unclear risk | The method used to conceal the allocation sequence was not described |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Data were nearly fully reported for each intervention group with 20% lost to follow‐up (Figure 1 in the trial report), reasons were not given. A similar number of participants were lost to follow‐up in each arm |
| Selective reporting (reporting bias) | Low risk | Evidence was available of proper outcome reporting |
| Other bias | Low risk | No apparent evidence of other risk of bias |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Masking of participants (p.1394 ‐ study medications): "To maintain masking, all medications had identical packaging, color, consistency, pH, and texture" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Investigators masked (p.1394 ‐ efficacy assessments): "...ocular signs (redness, eyelid swelling, and chemosis) were graded, using slit‐lamp examination and ordinal grading scales, by an investigator masked to treatment assignment." |